Retencion samples in Clinical Trials
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Do retention samples from clinical studies need to fulfil any special consideration in terms of storage than the commercial drugs? Annex 13 is so general about it. I have consulted some other guidelines (PDA guidelines) but I could not find any information that only applies for clinical trials. Thank you in advance for your support.
Please refer to COMMISSION DELEGATED REGULATION (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R1569&from=EN
) at Article 11 - Retention of samples used for quality control
GMP Committee response
Annex 13 provides the requirements for IMP reference and retention samples in paragraphs 36/37. It is not clear within you question which elements you are looking for more detailed information on. The annex is not explicit about storage conditions, but these are expected to be in accordance with the product label.
The reference to 2017/1569 is not effective at this present time. It will only be effective once 536/2014 is made effective and is subject to the transition period.