Glossary

A facility designed, constructed, and operated in accordance with cGMP guidelines established by the FDA.

A production facility or clinical trial materials pilot plant for the manufacture of pharmaceutical products. It includes the manufacturing space, the storage warehouse for raw and finished product, and support lab areas. A GMP facility operates under the guidelines established by the CFR (Code of Federal Regulations) Title 21, Parts 225 (Current Good Manufacturing for Medicated Feeds – Subpart B, Construction and Maintenance of Facilities and Equipment), and Part 226 (Current Good Manufacturing Practice for Type A Medicated Articles – Subpart B, Construction and Maintenance of Facilities and Equipment).

Lists of documents that describe the U.S.pharmaceutical GMP regulatory system arranged by Specific Equivalence Assessment Criteria asContained in Appendix 4 of the Pharmaceutical GMP Annex. Copies of all documents have been providedto the EMEA. http://www.fda.gov/oia/pharmgmp.html I. Legal/Regulatory authority and structures andprocedures providing for post- and pre-approval: A. Appropriate statutory mandate and jurisdiction. 1.U.S. Federal Food, Drug, and Cosmetic Act, As Amended Feb-1998: Section 201 (Title 21 United StatesCode (U.S.C.) Section 321) - Definitions. Section 501 (21 U.S.C. 351) - Adulterated Drugs and Devices. Section 502 (21 U.S.C. 352) - Misbranded Drugs and Devices. Section 505 (21 U.S.C. 355) - NewDrugs. Section 506 (21 U.S.C. 356) - Fast Track Products. Section 510 (21 U.S.C. 360) - Registrationof Producers of Drugs and Devices. Section 512 (21 U.S.C. 360b) - New Animal Drugs. Section 701(21 U.S.C. 371) - Regulations and Hearings. Section 702 (21 U.S.C. 372) - Examinations andInvestigations. Section 703 (21 U.S.C. 373) - Records of Interstate Shipment. Section 704 (21 U.S.C.374) - Factory Inspection. Section 705 (21 U.S.C. 375) - Publicity. Section 708 (21 U.S.C. 379) -Confidential Information. Section 709 (21 U.S.C. 379a) - Presumption. Section 711 (21 U.S.C. 379d)- Automation of Food and Drug Administration. Section 741 (21 U.S.C. 379k) - Information System. Section 742 (21 U.S.C. 379l) - Education. Section 801 (21 U.S.C. 381) - Imports and Exports. Section802 (21 U.S.C. 382) - Exports of Certain Unapproved Products. Section 803 (21 U.S.C. 383) - Office ofInternational Relations. Section 901 (21 U.S.C. 391) - Separability Clause. Section 903 (21 U.S.C.393) - Food and Drug Administration Mission Statement. 2. Public Health Service Act: Section 351 (42U.S.C. 262) - Regulation of Biological Products. Section 361 (42 U.S.C. 264) - Control ofCommunicable Diseases. 3. Federal Anti-Tampering Act, 18 U.S.C. 1365. 4. Administrative ProceduresAct (5 U.S.C. 551, et seq.) 5. Other Enforcement Acts: 18 U.S.C. Chapter 1 - Crimes - GeneralProvisions. 18 U.S.C. Chapter 7 - Assault. 18 U.S.C. Chapter 19 - Conspiracy. 18 U.S.C. Chapter 47- Fraud and False Statements. 18 U.S.C. Chapter 63 - Mail Fraud. 18 U.S.C. Chapter 73 - Obstructionof Justice. B. Ability to issue and update binding requirements on GMPs and guidance documents. 1. U.S.Federal Food, Drug, and Cosmetic Act, As Amended Feb-1998: Section 201 (21 U.S.C. 321) -Definitions. Section 701 (21 U.S.C. 371) - Regulations and Hearings. 2. Administrative Procedures Act -Section 553 (5 U.S.C. 553). 3. Code of Federal Regulations (CFR): 21 CFR 5 - Delegations of authorityand organization. 21 CFR 10 - Administrative Practices and Procedures. C. Authority to makeinspections, review and copy documents, and to take samples and collect other evidence. 1. U.S. FederalFood, Drug, and Cosmetic Act, As Amended Feb-1998: Section 201 (21 U.S.C. 321) - Definitions. Section 701 (21 U.S.C. 371) - Regulations and Hearings. Section 702 (21 U.S.C. 372) - Examinationsand Investigations. Section 703 (21 U.S.C. 373) - Records of Interstate Shipment. Section 704 (21U.S.C. 374) - Factory Inspection. Section 709 (21 U.S.C. 379a) - Presumption. Section 711 (21 U.S.C.379d) - Automation of Food and Drug Administration. 2. Public Health Service Act - Section 351 (42U.S.C. 262) - Regulation of Biological Products. 3. Code of Federal Regulations (CFR): 21 CFR 2.10 -Examination and investigation samples. 21 CFR 200.10 - Contract facilities utilized as extramuralfacilities by pharmaceutical manufacturers. 21 CFR 310.305(f)(3) - Records and reports concerningadverse drug experience for marketed prescription drugs without approved New Drug Applications. 21CFR 320.34(a) - Requirements for batch testing and certification by FDA. 21 CFR 320.36(b) -Requirements for maintenance of records of bioequivalence testing. 21 CFR 320.38 - Retention ofbioavailability samples. 21 CFR 320.63 - Retention of bioequivalence samples. 21 CFR 510.300 -Records and reports concerning experience with new animal drugs. 21 CFR 600.20 - 600.22 -Establishment Inspection. 21 CFR 601.10 - Establishment licenses; issuance and conditions. 4.Compliance Policy Guides: General Section 100.200 - FDA Jurisdiction over Products Composed ofInterstate Ingredients. Section 100.350 - FDA Jurisdiction on Indian Reservations. Section 100.500 -Common Carrier as a Relabeler, Repacker, Reprocessor. Section 100.550 - Status and Responsibilitiesof Contract Sterilizers Engaged in the Sterilization of Drugs and Devices. Section 160.300 - Requestsfor Records under Section 703. Section 160.750 - Drug and Device Products Found in Violation of GMPReconditioning. Human Section 460.100 - Hospital Pharmacies - Status as Drug Manufacturer. 5.Regulatory Procedures Manual: Chapter 2 - FDA Authority. Chapter 6 - Judicial Actions. Chapter10 - Other Procedures. D. Ability to enforce requirements and to remove products found in violation ofsuch requirements from the market. 1. U.S. Federal Food, Drug, and Cosmetic Act, As Amended Feb-1998: Section 201 (21 U.S.C. 321)- Definitions. Section 301 (21 U.S.C. 331) - Prohibited Acts. Section 302 (21 U.S.C. 332) - Injunction Proceedings. Section 303 (21 U.S.C. 333) - Penalties. Section 304 (21 U.S.C. 334) - Seizure. Section 305 (21 U.S.C. 335) - Hearing Before Report of CriminalViolation. Section 306 (21 U.S.C. 335a) - Debarment, Temporary Denial of Approval, and Suspension. Section 307 (21 U.S.C. 335b) - Civil Penalties. Section 308 (21 U.S.C. 335c) - Authority to WithdrawApproval of Abbreviated Drug Applications. Section 309 (21 U.S.C. 336) - Report of Minor Violations. Section 501 (21 U.S.C. 351) - Adulterated Drugs and Devices. Section 502 (21 U.S.C. 352) -Misbranded Drugs and Devices. Section 503 (21 U.S.C. 353) - Exemptions and Considerations forCertain Drugs, Devices, and Biological Products. Section 503A (21 U.S.C. 353a) - PharmacyCompounding. Section 505 (21 U.S.C. 355) - New Drugs. Section 506 (21 U.S.C. 356) - Fast TrackProducts. Section 512 (21 U.S.C. 360b) - New Animal Drugs. Section 701 (21 U.S.C. 371) -Regulations and Hearings. Section 702 (21 U.S.C. 372) - Examinations and Investigations. Section703 (21 U.S.C. 373) - Records of Interstate Shipment. Section 704 (21 U.S.C. 374) - Factory Inspection. Section 705 (21 U.S.C. 375) - Publicity. Section 709 (21 U.S.C. 379a) - Presumption. Section 711(21 U.S.C. 379d) - Automation of Food and Drug Administration. Section 742 (21 U.S.C. 379l) -Education. Section 801 (21 U.S.C. 381) - Imports and Exports. Section 802 (21 U.S.C. 382) - Exportsof Certain Unapproved Products. Section 803 (21 U.S.C. 383) - Office of International Relations. 2.Public Health Service Act: Section 351 (42 U.S.C. 262) - Regulation of Biological Products. Section361 (42 U.S.C. 264) - Control of Communicable Diseases. Section 2128 (42 U.S.C. 300aa-28) -Manufacturer Recordkeeping and Reporting. 3. Code of Federal Regulations (CFR): 21 CFR Part 1 -General enforcement regulations. 21 CFR Part 2 - General administrative rulings and decisions. 21CFR Part 5 - Delegations of authority and organization. 21 CFR Part 7 - Enforcement policy. 21 CFRPart 10 - Administrative practices and procedures. 21 CFR Part 12 - Formal evidentiary public hearing. 21 CFR Part 13 - Public hearing before a public board of inquiry. 21 CFR Part 15 - Public hearingbefore the Commissioner. 21 CFR Part 16 - Regulatory hearing before the Food and DrugAdministration. 21 CFR Part 17 - Civil money penalties hearing. 21 CFR 312.44 (b) (1) (iii) and (vi) -Termination of an Investigational New Drug. 21 CFR 314.170 - Adulteration and misbranding of anapproved drug. 21 CFR 314.125 - Refusal to approve an applica

Good Manufacturing Practices required by FDA regulations.

Glass Mat Thermoplastic

Greenwich Mean Time

Very small particles composed of membrane aggregates and responsible for the secretion of certain enzymes and macromolecules. Golgi bodies are the deposition and packaging site for many excreted products.

Any of the usually paired organs in animals that produce reproductive cells (gametes). The most important gonads are the male testis, which produces spermatozoa, and the female ovary, which produces ova (egg cells). The gonads also produce hormones that control secondary sexual characteristics.

A technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE). The goal of this committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry. The GAMP committee organizes training seminars for its members.These guidelines are:

1. GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures
2. GAMP Good Practice Guide: Calibration Management
3. GAMP Good Practice Guide: Electronic Data Archiving
4. GAMP Good Practice Guide: Global Information Systems Control and Compliance
5. GAMP Good Practice Guide: IT Infrastructure Control and Compliance
6. GAMP Good Practice Guide: Validation of Laboratory Computerized Systems
7. GAMP Good Practice Guide: Validation of Process Control Systems
8. GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems
9. GAMP Good Practice Guide: Legacy Systems
10. GAMP Good Practice Guide: Testing of GxP Systems

A system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users in the pharmaceutical industry.

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

Guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs, intended for human consumption.GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

Established engineering methods and standards that are applied throughout a project’s life cycle to deliver appropriate, cost-effective solutions.

A system whereby individual design decisions are performed by qualified personnel and documented so that they can be traced from user requirements through final design. GEP documentation considers purpose, responsible party, references, assumptions, calculation method, conclusions, and impact upon other facets of design. GEPs take industry practices, constructability, economics, regulatory requirements and safety into account.

A combination of standards, specifications, codes, regulatory and industrial guidelines as well as accepted engineering and design methods to design, construct, operate, and maintain pharmaceutical and/or biotechnology facilities taking into account not only regulatory compliance but also safety, economics, environmental protection and operability. Standards and specifications are provided by recognized sources such as established engineering and architectural contractors as well as pharmaceutical companies. Codes are provided by local, state, or federal jurisdictions and/or insurance companies. Guidelines are issued by professional societies, industrial organizations, or regulatory agencies. Engineering design methods have been established throughout the engineering educational system.

(MHRA) GLP embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

The National Institutes of Health (NIH) specifies physical containment levels and defines Biosafety Levels for Large Scale in their “Guidelines for Research Involving Recombinant DNA Molecules” (NIH Guidelines) – Appendix K – “Physical Containment for Large Scale Uses of Organisms Containing Recombinant DNA Molecules”. April 2002. Level of physical containment recommended for large-scale (more than 10 liters of culture) research or production involving viable, non-pathogenic, and non-toxigenic recombinant strains derived from host organisms that have an extended history of safe large scale use. Likewise, the GLSP level of physical containment is recommended for organisms that have a built-in environmental limitation that permits optimum growth in large-scale bioreactors, but limited survival if released to the environment.1.BL1-LS (Large Scale): Practices, safety equipment, and facilities appropriate for work performed with large scale (more than 10 liters) research or production of viable organisms containing recombinant DNA molecules that require BL1 containment at the laboratory scale and that do not qualify for GLSP.2.BL2–LS (Large Scale): Practices, safety equipment, and facilities appropriate for work performed with large scale (more than 10 liters) research or production of viable organisms containing recombinant DNA molecules that require BL2 containment at the laboratory scale.3.BL3–LS (Large Scale): Practices, safety equipment, and facilities appropriate for work performed with large scale (more than 10 liters) research or production of viable organisms containing recombinant DNA molecules that require BL3 containment at the laboratory scale.

Protective garments and the act of donning protective garments.

General Practitioners Committee (United Kingdom)

G-Protein Coupled Receptor

Good Practice Guide

Gallons Per Minute

Guinea Pig Maximization Test

General-Purpose Polystyrene

Global Positioning System