Description
Issued by:U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Veterinary MedicineOffice of Regulatory AffairsJuly, 2012
Scope & Applicability
Product Classes
1The subject of the temporary compounding policies.; Injectable drugs subject to temporary compounding policies
Stakeholders
1Oversees reprocess or rework of batches
Regulatory Context
Attributes
1Time required to destroy 90 percent of the vegetative cells or spores at a given temperature
Identified Hazards
Hazards
1risk to sterility assurance
Related CFR Sections (3)
- 21CFR211.192§ 211.192 Production record review.
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (inRead full regulation →
- 21CFR211.113§ 211.113 Control of microbiological contamination.
(a) Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.Read full regulation →
- 21CFR211.167§ 211.167 Special testing requirements.
(a) For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be appropriate laboratory testing to determine conformance to such requirements. The test procedures shall be in writing and shall be followed.Read full regulation →
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See Also (8)
- Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry (Status: Final)
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Status: Final)
- Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision: Guidance for Industry (Status: Final)
- Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (Status: Final)
- Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry (Status: Draft)
- Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry (Status: Final)
- Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry (Status: Final)
- Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry (Status: Draft)