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Retention Samples | FDA - U.S. Food and Drug …
- https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/retention-samples
- The Agency may then analyze these retention samples to ensure that the BA/BE results upon which FDA bases approval of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDAs) are...
eCFR :: 21 CFR 600.13 -- Retention samples.
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600/subpart-B/section-600.13
- § 600.13 Retention samples. Manufacturers shall retain for a period of at least 6 months after the expiration date, unless a different time period is specified in additional standards, a …
Retention Sample Requirements ISO 13485 and 21 CFR …
- https://elsmar.com/elsmarqualityforum/threads/retention-sample-requirements-iso-13485-and-21-cfr-part-820.22242/
- Sample Retention - Subcontracted Plating Service - PPAP Requirements: Service Industry Specific Topics: 11: Feb 9, 2004: N: Notification Sample Regarding …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=600.13
- Manufacturers shall retain for a period of at least 6 months after the expiration date, unless a different time period is specified in additional standards, a …
Retention and Disposal of GMP Documents and …
- https://www.gmpsop.com/pdfmanualsamples/Manual-002-Retention-and-Disposal-of-GMP-Documents-and-Retention-Samples.pdf
- The purpose of this procedure is to describe the minimum requirements for the retention of samples and documents under GMP and Medical Device regulations/legislation. Local …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=211.170
- (b) An appropriately identified reserve sample that is representative of each lot or batch of drug product shall be retained and stored under conditions consistent with …
EU GMP Annex 19: Reference and Retention Samples
- https://www.gmp-compliance.org/guidelines/gmp-guideline/eu-gmp-annex-19-reference-and-retention-samples
- Medical Devices and Combination Products; Packaging and Packaging Material; Data Integrity; Qualified Person (QP) GMP Auditing; Documentation; Cleaning …
21 CFR § 211.170 - Reserve samples. | CFR | US Law
- https://www.law.cornell.edu/cfr/text/21/211.170
- The retention time is as follows: (1) For a drug product other than those described in paragraphs (b) (2) and (3) of this section, the reserve sample shall be retained for 1 year …
Understanding Medical Device QMS Requirements For …
- https://www.meddeviceonline.com/doc/understanding-medical-device-qms-requirements-for-combo-products-medical-device-company-edition-0001
- Understanding Medical Device QMS Requirements For Combo Products: Medical Device Company Edition. By David Amor, MSBE, CQA, Medgineering. This …
1 Purpose 2 Scope - GMP SOP
- https://www.gmpsop.com/Manual-samples/QMS-MANUAL-005-Retention-and-Disposal-of-GMP-Documents-and-Retention-Samples.pdf
- This procedure covers GMP and Medical Device documentation and Reference/Reserve samples for Active Pharmaceutical Ingredients (API’s), Intermediates, Formulated …
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