Good manufacturing practices for pharmaceuticals : a plan for total quality control /
| Main Author: | |
|---|---|
| Other Authors: | |
| Format: | Book |
| Language: | English |
| Published: |
New York :
Marcel Dekker,
[1997]
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| Edition: | Fourth edition, revised and expanded. |
| Series: | Drugs and the pharmaceutical sciences ;
v. 78. |
| Subjects: |
Table of Contents:
- Status and applicability of U.S. regulations: current good manufacturing practices in manufacturing, processing, packaging, and holding of drugs
- Finished pharmaceuticals: general provisions (subpart A)
- Organization and personnel: (subpart B)
- Buildings and facilities: (subpart C)
- Equipment: (subpart D)
- Control of components and drug product containers and closures: (subpart E)
- Production and process controls: (subpart F)
- Packaging and labeling control: (subpart G)
- Holding and distribution: (subpart H).
- Laboratory controls: (subpart I)
- Records and reports: (subpart J)
- Returned and salvaged drug products: (subpart K)
- Repackaging and relabeling
- The inspection procedure for compliance in the United States: the regulatee is inspected; the rationale for inspection: (21 USC 373, 374)
- Recalls and CGMPs: enforcement alternatives in the United States
- Controlled substances safeguards: (21 CFR 1300, et seq.)
- Who is the manufacturer? Some additional considerations for the multinational.
- Bulk pharmaceutical chemicals
- FDA pre-approval inspections/investigations
- Other GMPs
- Other approaches to quality
- Import and export of pharmaceuticals and other products subject to CGMPs
- Appendix A: Potable water requirements: (40 CFR 141)
- Appendix B: Components/Repackagers
- Appendix C: Hearing procedures when FDA proposes the imposition of civil money penalities
- Appendix D: Section 601.12 changes currently considered "important" by CBER.