Pharmaceutical Terminology

Pharmaceutical Terminology 04/2020 AI Application Identifier Defines the purpose of the data in the symbol and how it is Acronym Term Explanation to be used. It is commonly used in GS1 . API Application Programming An application programming interface is a set of routines, 0-9 Interface data structures, object classes and/or protocols provided 1D One-dimensional barcodes are linear barcodes. They by libraries and/or operating system services in order to consist of vertical lines of varying widths with specific gaps support the building of applications. resulting in a particular pattern. Application Software (ISO) Software or a program that is specific to the solution of an 2D barcode (2D ) Two-dimansional barcodes look like squares or rectangles application problem. that contain many small, individual dots. A single 2D bar- ARGUS The unique ARGUS wt-system from Laetus offers a mo- code can hold a significant amount of information and may dular and network-ready packaging control system for the remain legible even when printed at a small size or etched packaging process with: device independent product data- onto a product. base, user managament, administration of devices, audit 3PSWL 3rd Party Software Layer Software that does not come frome the manufactureer. It trail. was programmed by a third party software provider. Audit (ISO) Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. A Audit Trail An audit trail (also called audit log) is a security-relevant Acceptance Criteria (IEEE) The criteria that a system or component must satisfy in or- chronological record and source of records that provide do- der to be accepted by a user, customer or other authorized cumentary evidence of the sequence of activities that have entity. affected a specific operation, procedure, or event. Acceptance Test (IEEE) Testing conducted to determine whether or not a system Authentication Authentication is the process of verifying that the product satisfies its acceptance criteria and to enable the customer code on the drug package is genuine and originated from to determine whether or not to accept the system. See also the authorized pharmaceutical manufacturer. Authentication Factory Acceptance Test (FAT), Site Acceptance Test (SAT). uses the unique product serial number information stored Active Directory A Microsoft Windows Server Service to manage access on a RFID tag or barcode on a drug’s packaging, at the rights in the network of the customer. The LNT User Ma- unit of sale level, so that it can be used by wholesalers and nagement can be linked to that service to allow a global set- pharmacies to verify the integrity of the drug package. up and maintenance of all users in the customer network. AUTMLB Auto Multiple Labels Label Layout design with static and variable data. ATTP Advanced Track & Trace Software platform based on Laetus S-TTS and UP Techno- AUTPRN Auto Label Printout Label Layout design with static and specific filled variable Platform logy. data as printout. ANVISA Agência Nacional de Vigilân- Brazilian Health Regulatory Agency is a regulatory body of AIC Autorizzazione all‘immissione To be marketed in Italy a medicinal product must have cia Sanitária the Brazilian government. It is responsible for the regulation in commercio obtained the Autorizzazione all‘Immissione in Commercio and approval of pharmaceutical drugs, sanitary standards (AIC) from AIFA or the European Commission. The marke- and regulation of the food industry. ting authorisation is issued following a scientific evaluation Aggregation Aggregation refers to the requirement by the manufacturer of quality and safety requirements of the medical product. to serialize each drug packaging unit (or unit of sale) with a Auxiliary code Used when auxiliary (helping) code or data are used for unique identity with the creation and recording of incremen- tracking the pack trough the packaging line. tal parent-child associations at each subsequent stage of packaging - bundles, cases and pallets. These associations enable single scans of pallets or shipping cases to capture B the detail of all units contained within. Batch Aa specific quantity of a drug or other material that is inten- AGSCHK AGgregation Size CHKeck Upon closing an order, the system performs a number of ded to have uniform character and quality, within specified checks in order to ensure the consistency of the aggrega- limits, and is produced according to a single manufacturing tion size of aggregated units and to identify items which are order during the same cycle of manufacture. in the status “Good Marked” or “Removed” but are not part BATCH constant The needed data in a production batch that is variable like of an aggregation. for example the date of expiry, but it is only entered once to AC Alternating Current Electric current which periodically reverses direction. the system per Lot and is the constant from production start Aluminum Seal Aluminum seal & „Flip-Off“ plastic cap units come pre-as- until the end sembled, ready to crimp using a required specialty crimper. BO Batch Order The procedure that instructs all the manufacturing lines on Color may be used for vial identification. See also Flip-Off how to produce a certain amount of some specific products. cap. Normally it is generated by a Plant Server. ANSI American National Standards Private non-profit organization that oversees the develop- Batch Protocol (Log file) Batch related protocol about all system events during a Institute ment of voluntary consensus standards for products, batch including inspection statistics (Total, Good, Ejected), services, processes, systems, and personnel in the United date (Year, Day, Time), configuration (used devices), events States. (user inputs, error) and other batch related data.

Pharmaceutical Terminology 04/2020 Pharmaceutical Terminology 04/2020 BDL Behaviour Description Lan- BDL is a programming language based on ANSI C with Change Control (PDA) A formal process by which qualified representatives from guage extensions for hardware description, developed to describe appropriate disciplines review proposed or actual changes hardware at levels ranging from the algorithm level to the to a computer system. The main objective is to document functional level. the changes and ensure that the system is maintained in a BBD Best before Date Also known as „expiry date“ in german it is called „Verfalls- state of control. datum = MHD = Mindesthaltbarkeitsdatum“ CW Check Weigher Automatic or manual machine for checking the weight of BCR (or Scanner) Device used to manually or automatically read a barcode. packaged commodities. Usually found towards the end of a production process and used to ensure that the weight of a Bespoke System (GAMP) A system produced for a specific customer, to meet their unit is within specified limits. defined set of user requirements. Also called Custom Built System. A managed process for developing and maintai- CFDA China Food and Drug Admi- The National Medical Products Administration (NMPA) (for- ning cross-organizational plans to counteract interruptions nistration merly the China Food and Drug Administration, or CFDA) to business activities. was founded on the basis of the former State Food and Drug Administration (SFDA). In March 2013, the former re- BOM Bill of Materials. Describe the raw materials, sub-assemblies, intermediate gulatory body was rebranded and restructured as the China assemblies, sub-components, components, parts and the Food and Drug Administration, elevating it to a ministe- quantities of each needed to manufacture a final product. rial-level agency. It may be used for communication between manufacturing partners, or confined to a single manufacturing plant. CIP Club Inter Pharmaceutique The CIP develops databases and services whose sole ob- jective is to facilitate interprofessional exchanges between Biometrics A method of verifying an individuals’ identity based on mea- actors in the world of health. Due to its independence, the surement of the individual’s physical feature(s) or repeata- CIP plays an essential role as a technical interface with the ble actions where those features and/or actions are both regulatory authorities, particularly in the field of traceability. unique to that individual and measurable. Closed System An environment in which system access is limited to per- Blister Blister pack is a term for several types of pre-formed plastic sons who are responsible for that content of electronic packaging used for small consumer goods, foods, and for records that are on the system. pharmaceuticals. COCAM The COCAMwt 880 is a code camera for reading bar codes Blob Detection In computer vision, blob detection methods are aimed at using a WVGA sensor with an industrial and very compact detecting regions in a digital image that differ in properties, design. It reads all current 1D and 2D bar codes including such as brightness or color, compared to surrounding regi- the PHARMA-CODE™. ons. Blockchain technology Blockchain technology is most simply defined as a decen- CFR Code of Federal Regulations The codification of the general and permanent rules and tralized, distributed ledger that records the provenance of a (US, book of law) regulations (sometimes called administrative law) published digital asset. in the Federal Register by the executive departments and Bollino Italy was one of the precursors of the implementation of agencies of the federal government of the United States. anti-counterfeit measures of drugs. “Bollino”is the word Itali- The CFR is divided into 50 titles that represent broad areas ans first used to introduce the unique serialized code. subject to federal regulation. Titel 21 - Food and Drugs. Bundle Set of cartons packed together (e.g. by a carton bundle Code Pool The Code Pool is a container of serial numbers and can be packer). considered as a big tank that regularly feeds codes to the T&T application. C COTS Commercial Off-the-Shelf Software defined by a market-driven need, commercially Calibration (ISO) The set of operations which establish, under specified Software (IEEE) available, and whose fitness for use has been demonstra- conditions, the relationship between values indicated by ted by a broad spectrum of commercial users. a measuring instrument or measuring system, or values CEN Committee for European The European Committee for Standardization (French: represented by a material measure or a reference material, Normalization Comité Européen de Normalisation) is a public standards and the corresponding values of a quantity realized by a organization whose mission is to foster the economy of the reference standard. European Union in global trading. Carton Packaging level of pharmaceutical products. Composite Code A combinations of a linear (1D) barcode and a 2D code. Case Packaging level of pharmaceutical products. Computer (ISO) A functional unit that can perform substantial computations, CRPT Center for Research in The CRPT was created to carry out global projects in the including numerous arithmetic operations and logic opera- Perspective Technologies in digital economy. It is developing the concept of the Eurasi- tions without human intervention. Russia an Economic Union marking to ensure the free movement Computer System (IEEE) A system containing one or more computers and associated of goods through the internal borders of the union and the software. ability to trace the movement of goods within this territory. CSV Computer Systems Validation Confirmation by examination and provision of objective evi- cGMP Current Good Manufacturing Practice. See also GMP. dence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled.

Pharmaceutical Terminology 04/2020 Pharmaceutical Terminology 04/2020 CIJ Continuous Inkjet printer Continuous-Inkjet-printer perform accurate and consistent DR Device Reflector The Device Reflector includes the mapping and the device product marking and coding, on almost any type of material. driver and connects a device to the standard data exchange Continuous Processing Material is simultaneously charged and discharged from the (SDE). production line process. Digital Signature An electronic signature based upon cryptographic methods CMO Contract Manufacturing Or- A company that serves other companies in the pharmaceu- of originator authentication, computed by using a set of ganization tical industry on a contract basis to provide comprehensive rules and a set of parameters such that the identity of the services from drug development through drug manufactu- signer and the integrity of the data can be verified. ring. DSCSA Drug Supply Chain Security Outlines steps to build an electronic, interoperable system COSI The COSI 221 is the most popular sensor worldwide for Act to identify and trace certain prescription drugs as they are verification of the Laetus PHARMA-CODE™, with a com- distributed in the United States. pact construction facilitating integration on any packaging machine. E Counter System functionality to count status of processed items. EAN/UPC An EAN-8 is an EAN/UPC symbology barcode and is deri- The counter can have different categories. Total (input), ved from the longer International Article Number (EAN-13) Good (output), Bad (reject). The Bad may have subcatego- code. It was introduced for use on small packages where ries like Quality (removed by QM). an EAN-13 barcode would be too large. It is encoded iden- Counterfeit A product which is produced and sold with the intent to de- tically to the 12 digits of the UPC-A barcode, except that it ceptively represent its origin, authenticity or effectiveness. has 4 (rather than 6) digits in each of the left and right hal- Crypto Code The crypto code ensures tamper-proof marking of each in- ves. EAN-8 codes are common throughout the world, and dividual product traded in Russia, through the interaction of companies may also use them to encode RCN-8 (8-digit two components: The first part is the identification element, Restricted Circulation Numbers), and use them to identify which consists of the globally unique GTIN and the serial own-brand products sold only in their stores. RCN-8 are a number. The second part is the verification element. subset of GTIN-8 which begin with a first digit of 0 or 2. Customer (ISO) Organization or person that receives a product. See also ECC 200 The term ECC200 refers to Data Matrix symbols which are User. generated according to the latest (and most sophisticated) built-in error correction methods. D ECS The ECS wt150-10 from Laetus is an eject control system specially designed for the particular requirements of a pa- Data Backup Procedure to save and restore all variable data like product cking machine. database, audit trail and batch protocol. Eject General term for items automatically removed from produc- DB Database It is a structured collection of records or data that is stored tion process. in a computer system EPC Electronic Product Code Successor to the barcode. The EPC was created as a DDS Data Distribution Service The DDS for real-time systems is an Object Management low-cost method of tracking goods using RFID technology. Group (OMG) machine-to-machine (sometimes called The EPC is designed as a universal identifier that provides middleware or connectivity framework) standard that aims a unique identity for every physical object anywhere in the to enable dependable, high-performance, interoperable, world, for all time. The EPC structure is defined in the EPC- real-time, scalable data exchanges using a publish–subscri- global Tag Data Standard, which is an open standard freely be pattern. available for download from the website of EPCglobal, Inc Data matrix code It is a two-dimensional matrix code consisting of black and EPCIS Electronic Product Code EPCIS enables users (companies, authorities, supply white „cells“ or modules arranged in either a square or rec- Information System chains, etc.) to significantly increase transparency and cont- tangular pattern. rol over their respective processes. DPL Data Processing Language As integrated development environment (IDE) and open ER Electronic Record Any combination of text, graphics, data, audio, pictorial, or source language, processing programming language has other information representation in digital form that is crea- been specifically developed for the communities of visual ted, modified, maintained, archived, retrieved, or distributed design, new media art, and electronic arts. by a computer system. De-Aggregation The break-down of a the parent - child relationship of an ES Electronic Signature A computer data compilation of any symbol or series of aggregated data set. symbols executed, adopted, or authorized by an individual Design (IEEE) (1), ISO (2) (1) The process of defining the architecture, components, to be the legally binding equivalent of the individual‘s hand- interfaces, and other characteristics of a system or compo- written signature. nent. Embedded XP Family of operating systems from Microsoft for use in (2) Set of processes that transforms requirements into spe- non-personal computer devices such as specialized indust- cified characteristics or into the specification of a product, rial controllers. process or system. End User Economics and commerce define an end-user as the per- Device Driver Converts the string generated by the mapper into a string son who uses a product. understandable for any specific device.

Pharmaceutical Terminology 04/2020 Pharmaceutical Terminology 04/2020 ERP Enterprise Resource Plan- It is an enterprise-wide information system designed to co- FDS Functional Design Specifica- A specification of an actual equipment to be designed in ning ordinate all the resources, information, and activities nee- tion order to fulfil a market need. ded to complete business processes such as order fulfilm- FEE Functional Execution Engine The functional execution engine enables several high level ent or billing. software modules to communicate with a diverse bunch of ePedigree An electronic pedigree is a legal chain of custody record hardware via the different software drivers by using a hard- that traces a drug from the manufacturer to the pharmacy ware independent execution method. and contains information about all transactions involving FS Functional Specification This specification should clearly and completely describe that drug. what the product will do. Should be produced such that EPC Global Joint venture between GS1 and GS1 US. It is an organiza- objective testing can be subsequently performed. tion set up to achieve world-wide adoption and standard- Functional Testing (IEEE) Testing that ignores the internal mechanism of a system or ization of electronic Product code (EPC) technology in an component and focuses solely on the outputs generated in ethical and responsible way. response to selected inputs and execution conditions. Also EUFMD EU Falsified Medicines Direc- Legal framework introduced by the European Commission, known as black-box testing. tive to improve the protection of public health within the Euro- FQ Functional Qualification Documented verification that a system functions according pean Union. It requires that a unique identifier must be en- to written and pre-approved specifications throughout all coded in a two-dimensional barcode printed on each unit of specified operating ranges. sale package which is to contain: product code, randomized serial number, expiration date, batch or lot number, National Healthcare Reimbursement Number (NHRN) if required G EFPIA European Federation of It represents 31 national pharmaceutical industry associati- GLN Global Location Number Part of the GS1 systems of standards. It is a simple tool Pharmaceutical Industries ons and 44 leading pharmaceutical companies operating in used to identify a location and can identify locations unique- and Associations Europe. ly where required. ECG Extended Code Generator Code generator for creating barcodes like Linear (1D) , GTIN Global Trade Item Number It is an identifier for trade items developed by GS1. Such Datamatrix (2D) / QR Codes. identifiers are used to look up product information in a data- EC External Communicator The transmission of information between a business and base which may belong to a retailer, manufacturer, collec- another person or entity in the company‘s external environ- tor, researcher, or other entity. ment. GUID Globally Unique Identifier lt is a unique 128-bit number that is produced by the Win- dows OS or by some Windows applications to identify a particular component, application, file, database entry, and/ F or user. FAT Factory Acceptance Test An Acceptance Test in the supplier‘s factory, usually invol- GAMP Good Automated Manufactu- Is both, a technical subcommittee of the International Socie- ving the customer. See also Acceptance Test. Contrast to ring Practice ty for Pharmaceutical Engineering and a set of guidelines Site Acceptance Test. for manufacturers and users of automated systems in the Flip-off cap Colored plastic cap for vials. Will be applied together with pharmaceutical industry. flip-off seal to the vial. Color may be used for vial identifi- GMP Good Manufacturing Practice For pharmaceuticals it is that part of quality assurance that cation. The plastic flip-off cap is easily removed to expose ensures that products are produced and inspected uniform- the underlying aluminum seal and center exposed rubber ly in accordance with the quality standards, ensuring that stopper or septa. Ideally suited for filling or emptying vial they conform with their intended use and approval docu- contents with a syringe. mentation. FDL Flow Description Language Allows users to describe design flows in a simple and rea- Grading Bar code quality check. Optional to verify the bar code print dable format. quality for ANSI (A … F) or ISO (4.0 … 0.5) grade. Flying (Batch) Change-over Product change from product A to product B in a continues- Recommended minimum resolution: ly running processes - without stopping the line. - Linear bar bode between 5 … 7.5 pixel / X-Module Typical in Non-Pharma processing. - Stacked bar code between 7.5 …10 pixel / X-Module FDA Food and Drug Administra- FDA is an agency within the United States Department of - 2-dimensional bar bode between 7.5 … 10 pixel / X-Modu- tion Health and Human Services. It is responsible for protecting le the public health by ensuring the safety, efficacy, and secu- The grading accuracy depends on various parameters rity of human and veterinary drugs, biological products, and especially if changed after calibration; lens adjustment medical devices. (zoom, iris, focus), camera resolution (distance), lighting intensity, camera gain. FNC1 Function Code 1 The FNC1 is an invisible character used to identify and separate fields for variable length application identifiers. GUI Graphical User Interface The user interface is the aggregate of means by which the The control character FNC1 turns a „simple data matrix“ users interact with the system, a particular machine, device, into a „GS1 data matrix“. It is coded according to the start computer program or other complex tool. character and shows the application that the code content is structured according to the GS1 standards.

Pharmaceutical Terminology 04/2020 Pharmaceutical Terminology 04/2020 GS1 Founded in 1977, GS1 is an international not-for-profit as- ISA International Society of Auto- ISA Standards help automation professionals streamline sociation dedicated to the development and implementation mation processes and improve industry safety, efficiency, and pro- of global standards and solutions to improve the efficiency fitability. and visibility of supply and demand chains globally and ISO International Standards Orga- This Organization develops and publishes International across multiple sectors. The GS1 System of standards is nization Standards ensure that products and services are safe, relia- the most widely-used supply-chain standards system in the ble and of good quality. world. ISA 95 Standard International standard for developing an automated inter- GS1-128 Code with 48 alphanumeric capacity, carries AI for Shelf face between enterprise and control systems. This standard Life, Lot code and GTIN. The GS1-128 is a standard de- has been developed for global manufacturers. Divided in veloped by the GS1 organization based on Code128. Up levels from levels. to 2009 the standard was called UCC / EAN-128 and was Level 4: Plant Production Level (usually ERP from custo- most commonly called EAN128. mer) Level 3: Manufacturing Operation Level (usually MES from H customer; Level of S-TTS Plant) Level 2: Monitoring and automation Control Level (S-TTS Handheld Scanner Manually scanning of a bar code or OCR. Line) H&S Risk Health & Safety Risk They may involve: guards not operating correctly, exposed Level 1: Production Process Level (S-TTS Cell) mechanisms causing human harm; open electrical connec- Level 0: Device Level. Not in all ISA 95 structures! tions; human contamination by API’s (active pharmaceutical Island Set of all the lines that can be controlled by a single Line ingredients). Computer. This can be defined basing on LAN characteris- HMI Human to Machine Interface Generic expression for the device providing the platform to tics, product amount, machine performances and so on. operate the GUI software. IPA Isopropyl Alcohol (70%) Most common and widely used disinfectant within pharma- ceutics, hospitals, cleanrooms, and electronics or medical I device manufacturing. Identification Device Generic terminology for units identifying parts within packa- Item Smallest unit of sales in pharmaceutical product ging process by reading a bar code or any other machine readable identifier. J In-Process Control Checks made during the production of a pharmaceutical Job Device specific setup to perform a task within production product and, if applicable, controlling the process to gua- process. rantee that the product conforms to its specification. INSPECT The Laetus INSPECT wt multi purpose camera system offers a huge range of software application modules that K make INSPECT wt a uniquely flexible web-based camera Key Practices (PDA) Processes essential for computer validation that consist of system, capable of meeting a wide variety of inspection tools, work flow and people. requirements throughout the packaging process. ICMV Inspect, Check, Mark & Verify The process on a production line that includes inspecting, L checking, marking and verifying. Label General term for layout specification of marking or printing IQ Installation qualification Documented verification that a system is installed according task. (PDA) to written and pre-approved specifications. Laetus UP The Laetus UP provides an uniform platform across all IEEE Institute of Electrical and World‘s larget technical professional organization. Profes- applications, generates and further processes large volu- Electronics Engineers sional association for electronic engineering and electrical mes of data and thereby simplifies data handling. If needs engineering. change, the solution can be quickly expanded with any IPC Industrial Personal Computer An industrial PC is a computer intended for industrial number of new modules. purposes (production of goods and services), with a form Line Application One or more process units are controlled by a line applica- factor between a nettop and a server rack. Industrial PCs tion. have higher dependability and precision standards, and are generally more expensive than consumer electronics. Line Cluster Set of physical lines whose cells can work together by aggregating in different flow lines. A line cluster may include IPC In Process Control Online monitoring of the running process, by measuring key one or more islands. parameters. Line Operator A line operator may have various roles and access rights IFAH International Forum on Ad- IFAH (previously known as the Smart Health Conference) but will typically use only prepared and approved setups or vancements in Healthcare is one of the world‘s leading healthcare conferences that PO‘s. explores the latest innovations in the industry.

Pharmaceutical Terminology 04/2020 Pharmaceutical Terminology 04/2020 LAN Local Area Network In T&T systems, the LAN connects all the cells to the Line Master Data Management Master Data is a list of the products and its packaging Computer and the Line Computer to the Plant Server. Also materials (bill of materials). Aggregation often links to the a direct link between one cell and the subsequent one can packaging materials, e.g. the blister or the carton box. be implemented. MRP Material Requirements Plan- It is a production planning and inventory control system Log File See Batch Protocol ning used to manage manufacturing processes. Login Process for the operator to enable related access rights at Maxi Code A two dimensional matrix, fixed size code. the system. MES Message Exchange System lt receives a XML file, parses it, whilst changing specified Lot A specific identified amount produced in a unit of time or data inside the database. At the same time, it also sends quantity in a manner that assures its having uniform charac- messages to the Line agent that contain information about ter and quality within specified limits. the changes that have been made. LOT number Identification number assigned to a particular quantity or lot of material from a single manufacturer. N Lot printing The batch or lot number associates an item with informa- NDC National Drug Code The NDC is a unique product identifier used in the United tion the manufacturer considers relevant for traceability of States for drugs intended for human use. (sNDC = seriali- the trade item to which the element string is applied. The zed National Drug Code) data may refer to the trade item itself or to items contained. The number may be, for example, a production lot number, NHRN National Healthcare Reimbur- GS1 developed the NHRN to meet the needs of global a shift number, a machine number, a time, or an internal sement Number supply chain participants. The NHRN allows an association production code. of the national number to the global GTIN. The national number and the GTIN can be captured in the same barcode LUMAT The luminescence sensor LUMAT by Laetus is ideal for in a single scan. recognising optically brightened materials, i.e. ones which have been enhanced with UV-luminiphores. NTIN National Trade Item Number Identification standards specifically developed for the verifi- cation of pharmaceutical products. Network (FDA) (1) (ISO) (2) (1) An arrangement of nodes and interconnecting branches. M (2) A system [transmission channels and supporting hard- Maintenance Staff Repairs, performs set-up of new production formats. Has ware and software] that connects several remotely located full parameter access and may need remote access. computers via telecommunications. Manufacturing tree Shows the material, component parts subassemblies and NAGCHK Not Aggregated Items Check Check on non aggregated (non parent - child relationship) other items in a hierarchical structure. data sets. MANVER Manual Verification Manual verification of printing by the ioperator by using hand scanner or just doing a visual inspection. O Verification manuals consist of hand-made calculation of a specific problem and comparison with results from of soft- ODL Object Description Language The original interface definition language created by Micro- ware. soft for specifying interfaces to be used in OLE Automation. MES Manufacturing Execution It manages and monitors work-in-process on the factory OTS soft- Off-the-Shelf Software A generally available software component for which the System floor including labor and production reporting, as well as ware user cannot claim complete software life cycle control. on-line inquiries and links to tasks that take place on the OPC Server Open Platform Communicati- Software module to communicate to device conform to the production floor. Manufacturing Execution Systems may ons Server OPC standard. include one or more links to work orders, receipt of goods, Open System An environment in which system access is not controlled by shipping, quality control, maintenance, scheduling or other persons who are responsible for the content of electronic related tasks. records that are on the system. Mapping Mapping describes a process to convert the incoming infor- Operating Environment All outside influences that interface with the computer sys- mation in to a string to be sent to the dedicated device (e.g. (GAMP) tem. Printer, Camera). OQ Operational qualification Documented verification that a system operates according MV Mark and Verify Mark (printing): Interface to printer: Receives serialized and (PDA) to written and pre-approved specifications throughout all non-serialized data from Line and sends it to the printing specified operating ranges. device. OCR Optical Character Recogni- It is the mechanical or electronic translation of images of Verify (verification): Interface to camera: Only in combi- tion handwritten, typewritten or printed text characters (usually nation with Mark. Receives the same data from the line as captured by a scanner) into machine-editable text. Che- Mark function and uses it as a reference to check the actual cking of text but using a specific font of characters. image in regards of readability and content. OCV Optical Character Verification Historically used in pharmaceuticals to denote checking of Marking Information about the contents and shipment of a package text by ‘show and go’ operation, without a pre-trained font of which is printed on or affixed to the surface of the package. characters. Markirovka Pilot program for Crypto Code in Russia. See also Crypto Code

Pharmaceutical Terminology 04/2020 Pharmaceutical Terminology 04/2020 OEE Overall Equipment Effective- A measure of how well a manufacturing operation is utilized POLYPHEM POLYPHEM wt is a color camera system from Laetus that ness compared to its full potential, during the periods when it is is used for online monitoring on blister machines. It features scheduled to run. It identifies the percentage of manufactu- a remarkably large range for the inspection of products in ring time that is truly productive. blisters. PDF 417 Portable Data File 417 A stacked linear barcode format used in a variety of applica- P tions such as transport, identification cards, and inventory management. The „417“ signifies that each pattern in the Packaging Level Defines the sequential steps in a packaging process. Can code consists of 4 bars and spaces in a pattern that is 17 be defined in general by Primary / Secondary / Tertiary etc. units long. or by naming the packaging level Blister, Carton, Case, Pallet etc. Predicate Rule Requirements set forth in the Act, the PHS Act, or any FDA regulation, with the exception of part 11. PO Packaging Order Special case of more general term production order. Limits the application to a packaging process. See also production Preventative Maintenance Type of maintenance that is regularly performed on a piece order. of equipment to lessen the likelihood of it failing. Palette Packaging level of pharmaceutical products. Process (ISO) A set of interrelated or interacting activities which transform inputs into outputs. Parallel Processing More than one process are running at the same time inde- pendend from each other. Process Parameter (PDA) A variable that defines or controls a process and can affect the outputs. PDA Parenteral Drug Association Gobal provider of science, technology and regulatory infor- mation and education for the pharmaceutical and biophar- Process Validation (PDA) Establishing documented evidence which provides a high maceutical community. degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications Password A series of numbers or symbols known only to the individual and quality attributes. user, for use in their unique identification to a system. Product (PDA) (1) (ISO) (2) (1) The intended result of activities or processes. Performance Qualification Documented verification that a system is capable of per- (2) Result of a process. (PDA) forming or controlling the activities of the processes it is required to perform or control, according to written and Product Database Human readable database for copy of complete system set- pre-approved specifications, while operating in its specified up related to a single product name. operating environment. PCS Production Configuration Set A PCS is a composition of parameters to run a production Periodic Review (PDA) A documented assessment of the documentation, proce- (product name, templates, system topology). An approved dures, records, and performance of a computer system to user opens a UI, where he can define product topology, determine whether it is still in a validated state and what system topology, functional topology, device layouts, map- actions, if any, are necessary to restore its validated state. pings and save the combination into a PCS which goes into The frequency of review is dependent upon the systems the repository. complexity, criticality, and rate of change. PO Production Order Process to start the real production by loading and prepa- PSI Pharmaceutical Security A trade association comprised of the security directors ring all required data. APO has a set of parameters and Institute from thirty-seven international pharmaceutical manufactu- variable data (manufacturing date, batch number, number rers. PSI’s principal mission is to address the problem of of copies). A production order uses master counterfeiting of pharmaceutical products in order to protect data and recipes. See also Packaging Order. public health. PON Production Order Number A production order is an order issued within a company to Pharmacode Also known as Pharmaceutical Binary Code, is a barcode produce a specific quantity of material within a certain timef- standard, used in the pharmaceutical industry as a packing rame. A production order may be issued pursuant to a sales control system. It is designed to be readable despite prin- order, and its issuance triggers a number of events. ting errors. Also well known as Laetus Code. PLC Programmable Logic Cont- An industrial digital computer which has been adapted for PPN Pharmacy Product Number The PPN has been developed to integrate existing local roller the control of manufacturing processes. systems into global standards of the International Standard- Programming Standards Written procedures describing coding [programming] style ization Organization (ISO). (PDA) conventions specifying rules governing the use of individual PZN Pharmazentralnummer The PZN (Pharma Central Number) is –within Germany –a constructs provided by the programming language, and unique identification key for medicine and other pharmacy naming, formatting, and documentation requirements which products to unambiguously identify products by trade name, prevent programming errors, control complexity and promo- dosage form, strength and package size. te understandability of the source code. Plant Server A computer that receives orders from a plant system. lt PO Purchase Order A commercial document and first official offer issued by a interfaces to ERP and warehouse. lt dispatches batch buyer to a seller indicating types, quantities, and agreed orders to Line Server. In addition, it may receive and store prices for products or services. Also calles a Buying Order cell device configurations as a backup feature.

Pharmaceutical Terminology 04/2020 Pharmaceutical Terminology 04/2020 Q Review (ISO) Activity undertaken to determine the suitability, adequacy QR Code Quick Response Code A two-dimensional code that was developed by the Japa- and effectiveness of the subject matter to achieve establis- nese company Denso Wave in 1994. Due to an automatic hed objectives. error correction, this method is very robust and therefore Revision Document revision: takes into account different revisions of widely used. a certain document, in order to keep a file history. Qualification (ISO) The process to demonstrate the ability to fulfill specified Rework Manual operations in production or in supply chain with requirements. LNT. Usually a change status of a serial number or perfor- Quality Management System Management system to direct and control an organization ming of a manual aggregation. (ISO) with regard to quality. Quality Plan (ISO) Document specifying which procedures and associated S resources shall be applied by whom and when to a specific Security (GAMP) The protection of computer hardware and software from project, product, process or contract. accidental or malicious access, use, modification, destruc- tion, or disclosure. Security also pertains to personnel, data, communications, and the physical protection of computer R installations. RFID Radio Frequency Identifier It is the use of an object (typically referred to as an RFID Serial Number Serial numbers are only numbers, sequential or random, tag) applied to or incorporated into a product, animal, or with a certain number of digits, reflecting some pattems. person for the purpose of identification and tracking using radio waves. SSCC Serial Shipment Container The SSCC is an 18-digit number used to identify logistics Code units. In order to automate the reading process, the SSCC Re-Aggregation As part of Rework the existing aggregation can be Re-Ag- is often encoded in a barcode, generally GS1-128, and can gregated after a previouse aggregation has been de-aggre- also be encoded in an RFID tag. gated. Serialization Serialization refers to a numerical system that assigns a Real-time It is the study of hardware and software systems that are unique number or identification code to each packaging subject to a „real-time constraint“, i.e., operational deadlines unit. A serialization scheme is built around a code structure from event to system response. that typically identifies the manufacturer, the product type, RTC Real-time Computing A computing that requires real-time constraints. and each specific item unit. RTOS Real-time Operating System An operating system conceived to deal to real-time cons- SGTIN Serialized Global Trade Item Code that consists of the GTIN plus a unique product or traints. Number serial number. The SGTIN scheme has three different enco- Record Retention (ISO) Storing and retaining quality records in an established and dings 64, 96, and 198. recorded period of time in such a way that they are readily SNI Serialized Numeric Identifier A product‘s SNI will include the item‘s National Drug Code retrievable in facilities that provide a suitable environment (NDC) and unique Serial Number (SN). SNI is also referred to prevent damage or deterioration and to prevent loss. to as sNDC or Serialized National Drug Code Records may be in the form of any type of media, such as SLA Service Level Agreement A commitment between a service provider and a client. Par- hard copy or electronic media. ticular aspects of the service – quality, availability, respon- Recipe The term recipe is no longer used for an LNT system. Re- sibilities – are agreed between the service provider and the cipe has been renamed into Production Configuration Set service user. (PCS). SAT Site Acceptance Test (IEEE) An acceptance test at the customer‘s site, usually involving Regression Analysis and A software verification and validation task to determine the the Customer. See also Acceptance Test, contrast to Facto- Testing extent of verification and validation analysis and testing that ry Acceptance Test. must be repeated when changes are made to any previous- Smart Spect The intelligent SmartSpect camera system from Laetus ly examined software products. combines a camera and high-performance image proces- Regression Testing Rerunning test cases which a program has previously exe- sing in one single unit. cuted correctly in order to detect errors spawned by chan- Source Code (FDA) (1) (1) Computer instructions and data definitions expressed in ges or corrections made during software development and (IEEE) (2) a form suitable for input to an assembler, compiler or other maintenance. translator. Reliability The ability of a system or component to perform its required (2) The human readable version of the list of instructions functions under stated conditions for a specified period of [program] that cause a computer to perform a task. time. Specification (IEEE) A document that specifies, in a complete, precise, verifi- Requirement (IEEE) (1, 2) (1) A condition or capability needed by a user to solve a able manner, the requirements, design, behavior, or other (ISO) (3) problem or achieve an objective. characteristics of a system or component, and often, the (2) A condition or capability that must be met or possessed procedures for determining whether these provisions have by a system or system component to satisfy a contract, been satisfied. specification, or other formally imposed documents. SDE Standard Data Exchange SDE is communication layer in LNT Systems; all LNT par- (3) Need or expectation that is stated, generally implied or ties (Agents) communicate exclusively through SDE. obligatory.

Pharmaceutical Terminology 04/2020 Pharmaceutical Terminology 04/2020 SOP Standard Operating Proce- A set of step-by-step instructions compiled by an organiza- Test Plan (IEEE) A document describing the scope, approach, resources, dure tion to help workers carry out complex routine operations. and schedule of intended test activities. It identifies test SOPs aim to achieve efficiency, quality output and unifor- items, the features to be tested, the testing tasks, who will mity of performance, while reducing miscommunication and do each task, and any risks requiring contingency planning. failure to comply with industry regulations. Test Procedure (IEEE) Detailed instructions for the set-up, execution, and evalua- Structural Testing (GAMP) Examining the internal structure of the source code. Inclu- tion of results for a given test case. des low-level and high-level code review, path analysis, TTO Thermal Transfer Overprinter Used for coding onto flexible packaging films and self-adhe- auditing of programming procedures, and standards actu- sive labels. Works with a high-resolution thermal print head, ally used, inspection for extraneous „dead code“, boundary which melts a wax and/or resin based ink from a very thin analysis and other techniques. Also known as white-box thermal transfer ribbon onto the substrate to be printed. testing. Traceability (ISO) Ability to trace the history, application or location of that Supplier (ISO) Organization or person that provides a product. which is under consideration. Supplier Management The ongoing process of evaluating a supplier against es- Track & Trace A system capable of uniquely identifying a specific product (GAMP) tablished quality standards, managing noted deficiencies, within the complete supply chain in both the directions (ma- and working with the supplier to improve the quality of its nufacturer to end-user and vice versa). products or services and documentation. TH Transaction History A transaction log (also transaction journal, database log, Supply Chain A supply chain, logistics network or supply network is a binary log or audit trail) is a history of actions executed by coordinated system of organizations, people, activities, a database management system used to guarantee ACID information and resources involved in moving a product or properties over crashes or hardware failures. Physically, service in physical or virtual manner from supplier to custo- a log is a file listing changes to the database, stored in a mer. stable storage format. Transaction history shows the trans- System (PDA) (ISO) (1) Equipment, procedures, and other resources required to actions that have been scheduled within bill pay. perform or control a process. TS Transaction Statement A statement, in paper or electronic form, that the entity is (2) Set of interrelated or interacting elements. transferring ownership in a transaction. System Life Cycle (IEEE) The period of time that begins when a system is conceived ITS Turkish Pharmaceutical Track The ITS defines the infrastructure constructed to track and and ends when the system is no longer available for use. and Trace System trace all units belonging to each pharmaceutical product in System Qualification (ISO) Process to demonstrate that a system has the ability to Turkey. The serialization providing the uniqueness of the fulfill specified requirements. units is ensured by the DataMatrix code instead of formerly System Restore Procedure to rebuild the complete computing system used barcode. including basic firmware, performed updates and or added options. U UDI Unique Device Identifier The Unique Device Identification System is intended to as- T sign a unique identifier to medical devices within the United TE Tamper Evident Tamper-evident describes a device or process that makes States. unauthorized access to the protected object easily detec- UID Unique Identifier Also known as a Unique Serical Code (USC); a numeric or ted. Seals, markings or other techniques may be used to alphanumeric string that is associated with a single entity make tampering evident. within a given system. UIDs make it possible to address TCP/IP Transmission Control Protocol and the Internet Protocol. It that entity, so that it can be accessed and interacted with. is the set of communications protocols used for the Internet UIM Unique Identifier of Medicine This Directive introduces harmonised European measures and other similar networks. In T&T systems such a protocol to fight medicine falsifications and ensure that medicines is used for transferring messages through the LAN. are safe and that the trade in medicines is rigorously con- Test (IEEE) (1) (ISO) (2) (1) An activity in which a system or component is execu- trolled. Measures include: ted under specified conditions, the results are observed or Obligatory safety features – a unique identifier and an an- recorded, and an evaluation is made of some aspect of the ti-tampering device - on the outer packaging of medicines. system or component. UML Unified Modelling Language It is a standardized general-purpose modelling language in (2) Determination of one or more characteristics according the field of software engineering. to a procedure. UPS Uninterrupted Power Supply An electrical apparatus that provides emergency power to a Test Case (IEEE) A set of test inputs, execution conditions, and expected load when the input power source or mains power fails. results developed for a particular objective, such as to exer- USC Unique Serial Code USCs are obtained combining serial numbers with a cer- cise a particular program path or to verify compliance with a tain product, so they become unique for that product. Can specific requirement. be applied to a carton, a bundle of cartons, a case of bund- les, a pallet of cases, etc. lt allows to uniquely identifying a product in the complete supply chain. Laetus terminology.

Pharmaceutical Terminology 04/2020 Pharmaceutical Terminology 04/2020 User (GAMP) The person, or persons, who operate or interact directly with the system. The User(s) and the Customer(s) are often not the same person(s), but may be. User ID An identity of a user known to the company, such as an employee reference number. UI User Interface Space where interactions between humans and machines occur. URS User Requirement Specifica- A requirement specification that describes what the equip- tion (GAMP) ment or system is supposed to do, thus containing at least a set of criteria or conditions that have to be met.

V Validation (FDA) Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Validation Plan (PDA) A document which describes the overall strategy and re- sponsible parties for validating a system within its operating environment. Variable Data Production data depending on the batch (lot). Different to fixed data related to the product itself. Verification (ISO) Confirmation, through the provision of objective evidence that specified requirements have been fulfilled. Virtual Aggregation ls used when the aggregaiton is performed without marking a real code or data to the pack. VDC Voltage Direct Current An abbreviation fot „volts DC.“ DC stands for „direct cur- rent,“ which means the voltage is constant

W Warehouse General term for customer area outside of standard ope- rational area. Warehouse activities may include inventory, distribution, reworking and repacking.

X XML XML - Extensible Markup It is a general-purpose specification for creating custom Language markup languages. It is classified as an extensible lan- guage, because it allows the user to define the mark-up elements. XML‘s purpose is to aid information systems in sharing structured data, especially via the Internet, to en- code documents and to serialize data. XSD XML Scheme Document Set of rules to which an XML document must conform in order to be considered valid according to that scheme. 6

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Pharmaceutical Terminology 04/2020