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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 quantity of representative material of each lot of each product, sufficient for …
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 …
CFR - Code of Federal Regulations Title 21 - Food and Drug …
- 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 quantity of …
Retention Samples for medical devices - Elsmar Cove Quality and ...
- https://elsmar.com/elsmarqualityforum/threads/retention-samples-for-medical-devices.82051/
- Unlike pharmaceutical, there is no requirement for sample retention in medical devices. In fact, in most cases there is no logic in doing so. It is done only in certain products …
Retention Sample Requirements ISO 13485 and 21 CFR …
- https://elsmar.com/elsmarqualityforum/threads/retention-sample-requirements-iso-13485-and-21-cfr-part-820.22242/
- If you are placing the device in the market, the losing of retention samples is a major non compliance. You will have to come up with a strong Corrective and Preventive Action …
CFR - Code of Federal Regulations Title 21 - Food and Drug …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=211.170
- The reserve sample shall be stored in the same immediate container-closure system in which the drug product is marketed or in one that has essentially the same …
Storage of Reference and Retain …
- https://q1scientific.com/storage-reference-retain-samples/
- Samples may therefore fall into two categories: Reference sample: a sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being …
Manual 052 Reference & Retention Samples - GMP SOP
- https://www.gmpsop.com/pdfmanualsamples/Manual-052-Reference-and-Retention-Samples.pdf
- storage of reference and retention samples under GMP regulations/legislation. Local regulatory requirements that require the retention of additional samples, increased sample quantities or …
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 Validation; …
Retention of Bioavailability and Bioequivalence Testing …
- https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/retention-bioavailability-and-bioequivalence-testing-samples
- SUPPLEMENTARY INFORMATION: In the Federal Register of November 8, 1990 (55 FR 47034), FDA published interim regulations to require the retention for a specified period of reserve …
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