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Introduction to Cgmp Sampling: the Basics

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Introduction to Cgmp Sampling: the Basics Introduction to cGMP Sampling: The Basics ampling” is a key current This article is an Good Manufacturing attempt to provide “SPractice (cGMP) activity that impacts nearly every activity of both a general manufacturing pharmaceutical prod- overview of ucts. Sampling is used during the sampling as it assessment of: applies to • Raw materials, labeling, and pharmaceutical components prior to release manufacturing, • Validation of equipment, pro- cesses, systems, and products AND a series • Products during production of specific • Finished products prior to release • Products during stability studies, applications and of sampling • Data before, during, and after pro- approaches for duction various products The appropriate knowledge and and activities application of cGMP requirements for sampling is critical to the development encountered in of a scientifically sound quality sys- industry. tem. This article is an attempt to pro- vide both a general overview of sam- by pling as it applies to pharmaceutical Eldon Henson manufacturing, and a series of specif- Director, Quality Assurance ic applications of sampling approach- KV Pharmaceutical es for various products and activities encountered in industry. 2 A Pocket Guide to cGMP Sampling Eldon Henson In this article, a general discussion of cGMP requirements for sampling will be followed by targeted discussions for incoming materials and dosage forms. Where applicable, specific examples and experiences of the author are provided to address typical situ- ations that can arise. The purpose of this article is not to provide a statistical tutorial on the mathematical principles of sampling plans, or to recom- mend definitive sampling plans to use in every circumstance. In- stead, the general principles and approaches that should be con- sidered for cGMP applications of sampling are presented and discussed. It is the author’s hope that this report will stimulate al- ternative approaches, introduce new considerations, and answer basic questions that create hurdles and issues in pharmaceutical manufacturing. Though the final section of this article provides a listing of sev- eral important and useful resources on sampling that may answer specific questions and concerns, the ultimate reference on acceptance sampling is Juran’s Quality Control Handbook. This exhaustive resource should be viewed as a “must-have” for every Quality Assurance (QA) professional. Juran’s Quality Control Handbook1 includes sections on sampling risks, implementation of acceptance sampling programs, attributes versus variables, relia- bility sampling, bulk sampling, and the definitive statistical basis for all aspects of sampling programs. No sampling plan should be developed without some regard for the approaches and consider- ations discussed by Juran, et at.1 cGMP Requirements for Sampling Before we look at the specific cGMP requirements for sampling, let’s look at what a sample is and means from a general perspec- tive. According to the American Heritage Dictionary, a sample (or sampling) as it might relate to cGMPs is defined as: “… a portion, piece, or segment that is representative of a whole; a specimen; a set of elements drawn from and ana- lyzed to estimate the characteristics of a population…” A Pocket Guide to cGMP Sampling 3 Eldon Henson In short, a sample is a portion that accurately represents the population from which the characteristics of the population can be determined. The cGMPs mention samples, sampling plans, or sampling methods repeatedly. When reviewed overall, there are four themes that occur throughout these references: ❶ Sampling plans and methods must be written and defined ❷ Samples must be representative of the population ❸ Samples or sampling plans must be based on appropriate statistical criteria, and ❹ Samples must be properly identified and handled Let’s examine each of these overall requirements in more detail. ❶ Sampling Plans and Methods Must be Written and Defined As with all cGMP requirements, sampling plans and meth- ods must be predetermined and written. The most com- mon approaches to written methods for sampling are: • Develop a single Standard Operating Procedure (SOP) that details the plan to use with predetermined inspection levels, sampling sizes, and acceptance limits – then, any individual requirement for sampling will simply refer to the sample plan SOP. • Develop a specific SOP detailing the sampling plan for use with each individual type of material – for example, an SOP will be written individually for incoming packag- ing components, raw materials, labeling, etc. Each approach has advantages, but the key consideration is that you must pre-determine the specific sampling plan to be used for any type of material to be tested. ❷ Samples Must be Representative of the Population Typically, we assume that any sample we obtain will accurately represent the entire population. However, this is not always the case. Some materials are not homogeneous due to: 4 A Pocket Guide to cGMP Sampling Eldon Henson • Segregation that occurs during blending, transport, or handling • Variability occurring during the manufacturing process, especially if the process is prolonged (such as during campaigns to manufacture packaging components) • Part-to-part variability, due to differences in manufacturing components (such as bottles formed on equipment with multiple heads) • Changes in operators during manufacturing • A variety of other factors that impact production consis- tency Let’s face it… though process validation is a key element in the pharmaceutical manufacturing process, it is not always consid- ered by vendors producing raw materials, packaging components, excipients, or labeling. Thus, the importance of an appropriate sampling plan is heightened for materials supplied by others. ❸ Samples or Sampling Plans Must be Based on Appropriate Statistical Criteria The use of an appropriate statistically-based sampling plan is important to ensure our sample is truly representative of the popula- tion. In other words, a solid sampling plan based on statistical crite- ria can provide additional confidence that the sample, or specimen, on which we base accept/reject decisions, will provide the “true” answer regarding the quality of the material. The term “statistics” often creates the impression that the sam- pling plan must be complex, and use extensive statistical tables, formula, and calculations. Though in some cases, it is appropriate to utilize and perform more complex data manipulations (for exam- ple, with Design Of Experiments [DOE] studies), sampling plans for routine uses can and should be simple and easy to use. Likewise, some feel that the use of a “universally accepted sam- pling plan,” such as Square Root of N plus one, fulfills the burden of a statistically-based sampling plan. There is actually no statistical basis for this particular sampling plan. Additionally, the use of MIL- STD 105E or American Society for Quality/American National A Pocket Guide to cGMP Sampling 5 Eldon Henson Standards Institute (ASQ/ANSI) Z1.4 sampling plans does not ensure that the plan is statistically-based. Some sampling plans derived from these widely used programs would actually allow acceptance of some lots with critical defects. Each sampling plan must be developed to consider the specific attributes being meas- ured, and the risks associated with accepting a defective lot. ❹ Samples Must be Properly Identified and Handled Finally, cGMPs mention, in several locations, the need to proper- ly identify and handle samples. Despite the relative simplicity of this requirement, most firms routinely fail product or material lots, or undergo Out-of-Specification (OOS) investigations due to either improper sample identification or poor handling of samples prior to testing. Any testing program and sampling plan must include appropriate requirements for labeling and handling. Now that we have discussed general cGMP requirements for samples or sampling, we will look in more detail at some approaches for sampling plans for specific materials and product dosage forms. In the following pages, approaches for sampling plans will be discussed for: • Incoming Packaging Components • Incoming Raw Materials • Labeling Materials • Non-sterile Liquid Products • Sterile Products • Creams, Suspensions, and Emulsions • Powder Blends • Tablets, Capsules, and Other Solid Dosage Forms First, let’s look at a few basic concepts related to sampling and sampling plans. Basics of Sampling and Sampling Plans Several concepts of sampling and sampling plans should be discussed briefly before we launch into a discussion on specific 6 A Pocket Guide to cGMP Sampling Eldon Henson pharmaceutical product types: ■ What is a Sampling Plan? A sampling plan is a written approach to collecting and testing samples to ascertain material conformance to quality require- ments. Included in the plan will be: • Sample size – The number of samples taken (or quantity) must be specified in the written plan. This will eliminate sam- pler discretion, and better ensure an appropriate and ade- quate sample. • Method of sampling – The exact manner in which samples are to be taken, and the sample location must be included. • Tests or assessments – The testing, inspection, or assess- ment required will be specified in the plan. Because the sam- pling (and testing) plan is pre-determined and written, the tests conducted will be directed toward determination of con- formance to requirements. • Criteria for acceptance/rejection – Specific criteria for
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