Nutraceuticals and the GMP's

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Nutraceuticals and the GMP’s

By John E. Lincoln

INTRODUCTION pathic remedies, and similar Nutraceuticals products, with the exclusion of Until recently, the taking of tobacco derivatives. Often listed and dietary vitamin or mineral supplements, under alternative medicine, many supplements and especially herbs, was categories are now, to varying considered to be at the fringes degrees, making inroads into consist of vitamin of respectability by mainstream mainstream medicine. These medicine. However, by 2005 the products are widely used by and mineral nutraceutical and dietary supple- Americans, with an estimated supplements, ment industry had become a 55 percent of American adults $182 billion global market, and a currently taking some form of herbs, essential $20.3 billion U.S. market, growing dietary supplement in any one oils, enzymes, at 2.6 % annually.1 month and 35 percent taking a An important reason for such multivitamin or multimineral sup- homeopathic acceptance is the growing effort plement throughout the year.2 remedies, and to replace anecdotal information on nutraceutical safety and effec- DSHEA similar products, tiveness with more scientifically with the exclusion based laboratory and clinical Adiscussion of the U.S. studies data. These studies, by nutraceutical industry and the of tobacco their very nature, require the use GMPs starts with DSHEA3, the derivatives. of products of proven consistency, Dietary Supplement Health and with repeatable and reproducible Education Act of 1994 (Public Law ingredients, standardized 103-417), and the Office of Dietary dosages, and reliable, verifiable Supplements (ODS). The ODS documentation. In other words, was established by DSHEA, at ingredients, processes, and the National Institutes of Health. documentation that are subject to the types of controls defined by current Good Manufacturing Practices (cGMPs). Nutraceuticals and dietary supplements consist of vitamin and mineral supplements, herbs, essential oils, enzymes, homeo-

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Dietary Supplement ‘Official’ Definition The FDA’s Center for Food Safety and Applied DSHEA defines a dietary Nutrition, Office of Nutritional Products, Labeling, supplement as a product taken by mouth that con- and Dietary Supplements (ONPLDS), is responsible tains an ingredient that is intended to supplement the for developing policy and regulations for dietary sup- diet.4 This includes: A product (other than tobacco) plements, nutrition labeling and food standards, intended to supplement the diet that bears or con- infant formula and medical foods, as well as for sci- tains one or more of the following dietary ingredients: entific evaluation to support such regulations and related policy development. ONPLDS staff also sup- •Vitamin port compliance and enforcement actions and is •Mineral responsible for the clinical review, data summaries, and as appropriate, follow-up and research related •Herb or other botanical to adverse events associated with dietary supple- •Amino acid ments and infant formula. •Any dietary substance for human use to Unlike pharmaceuticals, manufacturers of dietary supplement the diet by increasing the total supplements generally do not need to register their daily intake; or products with the FDA nor do they get FDA approval •Aconcentrate, metabolite, constituent, before producing or selling their products. However, extract, or combinations of these ingredients domestic and foreign facilities that manufacture and process, pack, or hold food for human or animal •Aproduct intended for ingestion in capsule, tablet, or liquid form consumption in the United States are required to register their facilities with the FDA. •Aproduct not represented for use as a There are obvious dangers associated with prod- conventional food or as the sole item of ucts that, while currently defined as “food” by the a meal or diet U.S. FDA for purposes of regulation, can often have • A product labeled as a “dietary supplement” side effects more in line with OTC drugs. Hence no •Aproduct such as an approved new drug, advertising or labeling can or should minimize the certified antibiotic, or licensed biologic that need for the consumer to discuss their anticipated was marketed as a dietary supplement or usage with a physician. This is not only due to pos- food before approval, certification, or license sible potentially dangerous side effects, but also (unless the Secretary of Health and Human possible interactions with certain medical pharma- Services waives this provision) ceutical regimens, e.g., antibiotics. All dietary supplement manufacturers must make Some of these products and/or ingredients may sure that product label information is truthful and not already be classified as “GRAS” (Generally Recog- misleading. When dietary supplement labeling state- nized As Safe) by the U.S. FDA, and officially listed ments can be construed to assist a bodily function, as such. that labeling must include the caution:

Food and Drug Administration Regulation “These statements have not been The U.S. FDA regulates dietary supplements evaluated by the Food and Drug under a different set of regulations than those Administration. This product is not covering “conventional” food and drug products – intended to diagnose, treat, cure, prescription and over-the-counter (OTC). Under or prevent any disease.” DSHEA, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is FDA’s post-marketing responsibilities include safe before it is marketed. There is currently no monitoring safety, e.g.: voluntary dietary supplement FDA ‘clearance’ or ‘approval’ process for dietary adverse event reporting, and product information, supplements. Currently, the FDA is responsible for such as labeling, claims, package inserts, and taking action against any unsafe dietary supplement accompanying literature. The Federal Trade Commis- product only after it reaches the market. sion (FTC) regulates dietary supplement advertising,

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though there is some overlap with the FDA. USP - Verified Ingredients The USP-Verified Dietary Ingredients Program Voluntary Industry Compliance to GMPs conducts testing to verify active and inactive ingredi- The GMPs, or Good Manufacturing Practices, ents used to manufacture dietary supplements to are the U.S. FDA’s codification of the quality and ensure consistent quality. These ingredients include: documentation systems required of medical device manufacturers and pharmaceutical or drug compa- •Fine chemicals nies. Drug products fall under Title 21 of the Code of •Vitamins Federal Regulations (CFR) Parts 210 and 211, while •Minerals medical devices fall under 21 CFR Part 820. When GMPs and dietary supplements are discussed, it is •Amino Acids almost always the pharma/drug model that is •Botanical Extracts assumed. Currently, dietary supplements are not •Non-Botanicals required to adhere to these requirements, but many nutraceutical companies have chosen to comply vol- USP-Verified Ingredient certification means that untarily. the ingredients used are of: Reasons for voluntary compliance generally involve industry’s recognition of one or both of the •Consistent quality following two basic reasons: •Strength, purity, and quality that meet the label claims 1. The value that compliance with the GMPs •Ingredients and products prepared in offers, in providing – accordance with accepted manufacturing •Consistency in manufacturing processes processes • Bases for legitimate studies and clinical • Manufacturing specifications that meet trials requirements for acceptable limits of contamination •“Leveling of the playing field” 2. A concern that future FDA regulation of the USP standards are enforceable by the FDA. industry is inevitable Testing is voluntary and is available to all interested manufacturers. A USP-Verified Ingredient certifica- Labeling is a separate issue, and is controlled by tion seal is displayed on all such verified products. the FDA under “foods.” The U.S. FTC also monitors advertising claims. USP Assessment Process USP - Verified Ingredient status is obtained UNITED STATES PHARMACOPOEIA through assessment of the following:

The United States Pharmacopoeia (USP) is the •Evaluation of laboratory ingredient samples official authority in setting standards for all prescrip- for compliance with label claims and USP tion and OTC medicines, dietary supplements, and program requirements other healthcare products manufactured and sold in •Review of manufacturing and quality control the United States. Founded in 1820, the USP is an documentation independent, not-for-profit, public health organiza- •Audit of manufacturers quality systems for tion and is committed to developing public stan- compliance with Good Manufacturing Prac- dards to help assure good quality in medicines, tices healthcare delivery, dietary supplements, and related products and practices.

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NSF INTERNATIONAL NSF Certification Process The NSF International is a not-for-profit, non- Third party auditors conduct on-site inspections governmental organization founded in 1944 as the of manufacturing facilities and provide NSF with National Sanitation Foundation and committed to copies of all audit and corrective action reports. public health, safety, and protecting the environ- To earn NSF Dietary Supplement certification ment. Serving manufacturers operating in 80 coun- (see also NSF GMP Registration Program below) tries, NSF bills itself as “The Public Health and the program includes: Safety Company™, providing public health and safety risk management solutions to companies, •Good Manufacturing Practice audits governments, and consumers around the world.” •Label and formulation review Now known as NSF International, the company •Product testing develops standards and criteria for equipment, products, and services that bear upon health, •Clinical study review and serves manufacturers operating in 80 different •Toxicological review countries. The foundation offers independent testing, certification, auditing, and toxicology The program includes the following elements: consulting services throughout the world. NSF’s Dietary Supplement Certification Program is •Inspect manufacturing facility designed to help consumers and healthcare •Inspect product formulations practitioners identify supplement products that •Test contents for quantity of ingredients have been tested by a third-party organization. •Test contents for contaminants NSF Dietary Supplement Certification •Test contents for disintegration Product formulations and labels are tested to • Open to all manufacturers ensure: • Voluntary participation • Products contain the identity and quantity •Fee paid for testing of ingredients listed on the label • Products are free of any undeclared contaminants NSF GMP Registration Program NSF’s Good Manufacturing Practices Program Testing for NSF Dietary Supplement Certification (GMP) is designed to provide a system of is voluntary and available to all manufacturers. processes, procedures, and documentation to Standards for certification were developed by NSF ensure that the product produced has the identity, and the American National Standards Institute strength, composition, quality, and purity that it is (ANSI), also known as NSF/ANSI 173. represented to possess. The NSF GMP Registration Program is available to all manufacturers, is voluntary, and is based on a proposed set of GMPs developed by four industry trade associations. The program was submitted to the FDA in 1995. These proposed GMPs are designed to address the unique circumstances of dietary supplement production.

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THE NATURAL NUTRITIONAL FOODS ASSOCIATION A member supplier who receives an "A" is imme- diately able to apply for the right to use the certifica- The Natural Nutritional Foods Association tion mark. Those who receive a "B" are able to (NNFA) is a non-profit organization dedicated to the apply once the problems have been corrected, and natural products industry. Founded in 1936, the those with a "C" rating must submit for a re-audit. NNFA protects the values and interests of retailers Certified companies are audited every three years and suppliers in the natural nutritional foods and to verify continued compliance with NNFA GMPs. products industry. It represents more than 1000 manufacturers and 3000 retailers of health foods, Production Methods dietary supplements, natural ingredient cosmetics, Production of nutraceuticals (see Figure 1: Pro- and other natural products. duction Steps) generally follows the pharma model as far as tablet formulation, encapsulation of powder NNFA GMP Certification Program or liquid, time release, and other technologies or The NNFA’s Good Manufacturing Practices processes. Key differences include: the lack of Program (GMP) was launched in January 1999. mandatory qualification, validation documentation, It is designed to review all elements of the manufac- preventive maintenance, instrumentation calibration, turing process and ensure that the processes of the and similar requirements, which are key require- manufacturing facility are controlled in order for ments of the U.S. FDA’s GMPs (see 21 CFR Part products to meet their purported quality. 210, 211). However, this drawback is changing with Inspections for cleanliness, equipment mainte- the nutraceutical industry’s voluntary adoption of the nance, record keeping, and receiving of raw materi- GMPs. als are conducted to identify whether NNFAspecified There are many producers who have not yet performance standards are met. The standards iden- adopted these strict and somewhat costly GMP sys- tified by the NNFA have been through FDA review. tems and procedures. However, several trends are driving changes in this attitude, and are promoting Assessment Process compliance: Third party auditors conduct on-site inspections of manufacturing facilities of NNFAmember compa- • Consumer demand for quality control and nies, and provide the NNFA with copies of all audit standardized product and corrective action reports. The audits are per- •The increasing requirement for valid research formed by one of the NNFA approved companies, to support claims and allow targeting of spe- which utilize former FDA staff to conduct the audits. cial health concerns, requiring standardized, Once certified, manufacturers are given a compli- consistent, known product ance rating. The Performance Rating System is as •Partial entry into this market by “big pharma” follows for a member supplier: •Globalization of the market •“A”: Excellent compliance with NNFAGMPs, •Demands by large buying groups, including with few deficiencies noted “Big Box” retailers • “B”: Good compliance with NNFA GMPs, but •Industry perception of the entry of the FDA several significant deficiencies were noted into the nutraceutical industry at some point in the future, accompanied by mandatory •“C”: Fair or poor compliance with NNFA compliance to a quality system standard GMPs, many deficiencies noted; a re-audit is required •Company recognition of the inherent advantages of such quality systems •Business needs for control and monitoring of changes

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Figure 1 Typical Key Nutraceutical Production Steps

Start

Container (purchased or QC molded RM Inventory: QC Encapsulate in-house) To Production, Ingredients as needed

Labeling QC

Rejects Encapsulation Fill Material, QC Container if applicable

Active QC Lab Ingredient QC QC

Active QC Lab Ingredient Blend Ingredients Inert Ingredient(s); QC Lab Fillers

Any additional QC Lab non-nutrient ingredient

Seal Bottle; Box, Cap; QC Package Shrink Seal Label

QC Ship End

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Change Control – CONCLUSION OEM Materials and Production Methods The nature of the industry and its increasing Change control has always been a big issue with globalization, indicate a wide disparity in the consis- the FDA as it pertains to regulated industries, such tency and/or quality of the efforts outlined above. as food, medical devices, drugs and cosmetics - However, as volume increases, and the market especially drugs. It is correctly viewed as a major shifts to the large producers, use of the pharma component in quality maintenance, where its break- model by the industry should increase. It should be down results in unintended quality problems being noted that countries such as mainland China and introduced after poorly managed control of changes India are already utilizing such quality systems in (to product, process or equipment, testing, etc.). It is their large industries to offer a regulated production required to maintain the integrity of costly valida- environment and products in a bid to grow their tions. It is also a key component of the GMPs, ISO share of the global markets, including nutraceuticals 9001, ISO 13485, and similar quality systems stan- and dietary supplements. Based on these trends dards (see Figure 2). Change control requires that and business needs the voluntary use of the no changes in raw materials, formulations, methods cGMPs, or similar quality systems in dietary supple- of production, packaging, storing, or any other ment manufacture, will undoubtedly only increase.J activity that does or could affect product quality take place without proper documentation, including testing, and approvals. ABOUT THE AUTHOR Recognizing its inherent value to stabilize production, failure investigation, product improvement, John E. Lincoln is Principal of J. E. Lincoln and Asso- process and equipment validations, human or clini- ciates, a consulting company serving the medical cal trials, and similar advantages, the nutraceutical device and pharma industries (start-up to Fortune industry, pushed by various trade associations such 100 multinationals), with over 25 years industry as those mentioned above, has been voluntarily experience. He specializes in implementing regula- adopting these important quality management sys- tory solutions that make business sense. This tem principles. includes Device Project Management, Risk Manage- ment, Cycle Time Reduction, Quality Systems, and Cleanliness and Sterilization Method Concerns Regulatory issues and submissions. He has held The industry’s move to voluntary compliance to positions as Director of QS/RA, VP R&D, Sr. QA the GMPs, as well as a growing public awareness Engineer, and Sr.Manufacturing Engineer, with com- of “green” issues, and a concern for the quality of panies such as Abbott Laboratories, Hospira, and products used and consumed, is driving closer Mallinckrodt Medical. review of the inherent variability in the quality of incoming raw materials, and the required processing Additional experience has been with Sperry Univac steps. Large nutraceutical manufacturing companies (Unisys), Hughes Aircraft – Aerospace, U.S. Army utilize many elements of the pharma model in the Signal Corps / Depot Staff, and the City of Los treatment of incoming raw materials, eliminate Angeles’ Administrative/Budget Office. He has source contamination, and maintain the cleanliness received several awards for breakthrough project of production lines. This includes the periodic implementation, is listed in Who’s Who – Science cleaning of production lines and processing equip- and Engineering, and has authored numerous peer- ment using validated chemicals, methods, and reviewed articles on medical device and regulatory trained personnel. issues. He is on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of GXP Compliance, on the board of the IBA (Intermountain Biomedical Association), and is publisher of a medical device newsletter. He is a graduate of UCLA. John can be reached at www.jelincoln.com, phone at 888-882-4655, and e-mail at [email protected].

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Figure 2 Comparison between 21 CFR 210, 211 (the Drug GMPs), and ISO 9001:2000 (Quality Management System)

Drug Good Quality Area of Interest Manufacturing Management System Practice (GMP/CFR) (ISO/ANSI/OTHER)

Labeling • 21 CFR 211.122, • ISO 9000:2000 5.6, 211.125, 211.130, 7.5, and 8.2 211.132, 211.137, and 211.184 Manufacturing • 21 CFR 211.130, • ISO 9000:2000 7.5, Procedures 211.132, 211.160, 7.6, and 8.2 211.184, and 211.204 Additional • 21 CFR 211.103, • ISO 9000:2000 6.5, Manufacturing 211.110, 211.115, 7.5, 7.6, and 8.2 Procedures 211.134, 211.165, 211.182, 211.188, and 211.194 Warehousing • 21 CFR 211.142, • ISO 9000:2000 7.5 and Distribution 211.150, 211.165, and 8.3 211.188, and 211.196 Complaint Process • 21 CFR 211.192, • ISO 9000:2000 5.2, 211.198, and 211.204 5.3, 7.2, 8.3, 8.4, • 21 CFR 310.305 and 8.5 • 21 CFR 314.80 Calibration Program • 21 CFR 211.67, • ISO 9000:2000 7.5, 211.68, 211.105, 7.6, and 8.2 211.110, 211.182, and 211.194 Receipt, Inspection, • 21 CFR 211.82, • ANSI/ASQC Z 1.4-1993 and Disposition 211.101, and 211.84 IVTGXP_JULY07.qxd 6/18/07 11:39 AM Page 20 • ISO 9000:2000 5.2, 7.2, 7.4, and 8.3 Returns and Salvage • 21 CFR 211.204, • ISO 9000:2000 5.2, 7.2, and 211.208 8.3, and 8.4 JohnContainer E. Lincolns • 21 CFR 211.82, • ISO 9000:2000 7.2, 7.4, 211.84, 211.86-87, 7.5, and 8.3 211.89, and 211.94 Figure 2 (Continued) Expiration Dating • 21 CFR 211.125, • ISO 9000:2000 5.3, 7.5, Comparison between 21 CFR 210, 212111.130, (the 21 Drug1.137, GMPs), and ISO 9001:2000 8.2, and 8.3 (Quality Management System) and 211.166 Non-Conforming Material • 21 CFR 211.84, • ISO 9000:2000 8.3, Report (NCMR) 211.87, 211.89, 211.115, 8.4, and 8.5 andDrug 211.18 Go8 od Quality Area of Interest Manufacturing Management System Batch (Lot) Records • Practi 21 CFRce 211 (GMP.188/CFR) • ISO(ISO/ 9000:ANSI/O2000 7.THER5 ) and 211.192 and 8.2 MastLabelierng Records • 21 CFR 211.18.1262, • ISO 9000:2000 4,5.6, 5.2, an211.125,d 211.19 2121.130, 5.7.3,5, 5.7,and 7.58.2, 8.2, and 8.5 211.132, 211.137, and Change Control • 21 CFR 211.100 • ISO 9000:2000 7.3, 7.5, 211.184 and 211.186 7.6, 8.3, 8.4, and 8.5 Manufacturing • 21 CFR 211.130, • ISO 9000:2000 7.5, Batch (Lot) Release • 21 CFR 211.188 • ISO 9000:2000 4, 5.6, Procedures 211.132, 211.160, 7.6, and 8.2 and 211.192 7.2, and 7.5 211.184, and 211.204 Personnel and Training • 21CFR 211.25 (a) • ISO 9000:2000 6.2, Additional • 21 CFR 211.103, • ISO 9000:2000 6.5, and 211.34 6.4, 6.5, and 8.5 Manufacturing 211.110, 211.115, 7.5, 7.6, and 8.2 Procedures 211.134, 211.165, • Applicable state licensing 211.182, 211.188, and/or pharmaceutical and 211.194 requirements FacilitWarehousingies Syst ems • 21 CFR 211.42.14,2, 211 .44, • ISO 9000:2000 6.4,7.5 7.2, and Distribution 211.46,1.150, 211 21.481.1,65, 21 1.50, 7.an3,d and8.3 8.2 211.52,1.188, 211 and.56 21, an1.196d 211.58 EquipmentComplaint ProcessMaintenance • 21 CFR 211.67.19,2, 211 .105, • ISO 9000:2000 7.5,5.2, 7.6, and Cleaning an211.198,d 211.18 and2 211.204 an5.3,d 8.57.2, 8.3, 8.4, Product Recall • 21 CFR 211310.3.11055, 211.196, • IanSOd 8.59000:2000 5.2, 5.3, and 211.204 5.6, 7.2, 8.3, 8.4, and 8.5 • 21 CFR 314.80 • 21 CFR Part 11.5.1 Calibration Program • an 21d CFR Part 211 7 .67, • ISO 9000:2000 7.5, 211.68, 211.105, 7.6, and 8.2 Verification and • 211.110, CFR Part 211.18 11 2, • ISO 9000:2000 4, 5.6, 7.2, Validation (Eanlectrod 211nic.19 4Records 7.3, 7.5, 7.6, 8.2, 8.4, and 8.5 and Signatures) Receipt, Inspection, • 21 CFR 211.82, • ANSI/ASQC Z 1.4-1993 and Disposition • 211.101, CFR 211 and.42 21, 1.84211.63, 211.68, 211.186, and 211.192 • ISO 9000:2000 5.2, 7.2, 7.4, and 8.3 Quality Policy • 21 CFR 211, • ISO 9000:2000 4, 5.4, Returns and Salvage • 21 CFR 211.204, especially 211.22 (a), • 5. ISO5, 5.6,9000: 8.42000, an d5.2, 8.5 7.2, 21an1.100d 211 .20(a 8and b) 8.3, and 8.4 • Applicable state licensing Containers • 21 CFR 211.82, • an ISOd/or 9000: pharm2000aceut 7.2,ica 7.4l , 211.84, 211.86-87, re7.5,quir andement 8.3s. 211.89, and 211.94 • Industry Best Practices Expiration Dating • 21 CFR 211.125, • ISO 9000:2000 5.3, 7.5, 211.130, 211.137, • ISO 9000:2000 4, 5.1, Outside Audit Policy • 21 CFR 211.22 8.2, and 8.3 and 211.166 5.5, 5.6.2, 8.4, and 8.5 SiteNon-Conforming Registration PoMatlicyerial • 21 CFR 205211.84 and, • ISO 9000:2000 1.1(8.3, b), Report (NCMR) 211.87, 211.89, 211.115, 4.1 (Note), 4.2.3, 4.2.4, 5.1 • 21 CFR 211.1 8.4, and 8.5 and 211.188 • Applicable state licensing Batch (Lot) Records • 21 CFR 211.188 • an ISOd/or 9000: pharm2000aceut 7.5ica l requirements. and 211.192 • Oanthed 8.2r applicable requirements, Master Records • 21 CFR 211.186 • e. ISOg., 9000:DOT, 2000OSH A,4, 5.2,JCAHO and 211.192 5.3, 5.7, 7.5, 8.2, and 8.5

Change20 ControJournall of GXP Compliance• 21 CFR 211.100 • ISO 9000:2000 7.3, 7.5, and 211.186 7.6, 8.3, 8.4, and 8.5 Batch (Lot) Release • 21 CFR 211.188 • ISO 9000:2000 4, 5.6, and 211.192 7.2, and 7.5 Personnel and Training • 21CFR 211.25 (a) • ISO 9000:2000 6.2, and 211.34 6.4, 6.5, and 8.5 • Applicable state licensing and/or pharmaceutical requirements Facilities Systems • 21 CFR 211.42, 211.44, • ISO 9000:2000 6.4, 7.2, 211.46, 211.48, 211.50, 7.3, and 8.2 211.52, 211.56, and 211.58 Equipment Maintenance • 21 CFR 211.67, 211.105, • ISO 9000:2000 7.5, 7.6, and Cleaning and 211.182 and 8.5 Product Recall • 21 CFR 211.115, 211.196, • ISO 9000:2000 5.2, 5.3, and 211.204 5.6, 7.2, 8.3, 8.4, and 8.5 • 21 CFR Part 11.5.1 and Part 7 Verification and • 21 CFR Part 11 • ISO 9000:2000 4, 5.6, 7.2, Validation (Electronic Records 7.3, 7.5, 7.6, 8.2, 8.4, and 8.5 and Signatures) • 21 CFR 211.42, 211.63, 211.68, 211.186, and 211.192 Quality Policy • 21 CFR 211, • ISO 9000:2000 4, 5.4, especially 211.22 (a), 5.5, 5.6, 8.4, and 8.5 211.100 (a and b) • Applicable state licensing and/or pharmaceutical requirements. • Industry Best Practices • ISO 9000:2000 4, 5.1, Outside Audit Policy • 21 CFR 211.22 5.5, 5.6.2, 8.4, and 8.5 Site Registration Policy • 21 CFR 205 and • ISO 9000:2000 1.1(b), 4.1 (Note), 4.2.3, 4.2.4, 5.1 • 21 CFR 211.1 • Applicable state licensing and/or pharmaceutical requirements. • Other applicable requirements, e.g., DOT, OSHA, JCAHO

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REFERENCES Article Acronym Listing 1 Nutrition Business Journal, www.newhope.com, 03/08/2006. ANSI American National Standards Institute 2 NTSBS Data, Products and Services Information CFR Code of Federal Regulations Services, Stats and Survery, NNFA Consumer Survey, DOT Department of Transportation 2001. DSHEA Dietary Supplements Health and 3 http://www.fda.gov/opacom/laws/dshea.html Education Act 4 “The Dietary Supplement Health and Education Act of FDA Food and Drug Administration 1994,” U. S. Food and Drug Administration Center for Food FTC Federal Trade Commission Safety and Applied Nutrition, December 1, 1995. GMP Good Manufacturing Practice 5 JCAHO, Joint Commission on Accrediation of Healthcare GRAS Generally Recognized As Safe Organizations, is a US-based non-profit organization ICH International Conference on formed in 1951 with a mission to maintain and elevate the Harmonization standards of healthcare delivery through evaluation and JCAHO Joint Commission on Accreditation accreditation of healthcare organizations. The Joint Com- of Healthcare Organizations mission employs surveyors who are sent to healthcare NNFA National Nutritional Foods Association organizations to evaluate their operational practices and NSF National Science Foundation facilities. Organizations deemed to be in compliance with all ODS Office of Dietary Supplements applicable standards are “accredited.” Hospitals and some ONPLDS Office of Nutritional Products, Labeling, other types of healthcare organizations, as accredited orga- and Dietary Supplements nizations are deemed by the Centers for Medicare and OSHA Occupational Safety and Health Medicaid Services to meet the Medicare and Medicaid cer- Administration tification requirements – necessary for gaining reimburse- OTC Over-The-Counter ment from Medicare and managed care organizations – U.S. United States Wikipedia, USP United States Pharmacopoeia http://en.wikipedia.org/wiki/Joint_Commission_on_Accredi- tation_of_Healthcare_Organizations

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