Recently USFDA's department of Center for Drug Evaluation and
Research (CDER) has published a "New Guidance Policy for Quantity of
Retained Samples for BA and BE studies"
USFDA regularly publishes new guidance for industry to maintain compliance in the pharmaceutical industry.
Recently in August 2020, USFDA has published a compliance policy is named as:
This policy is applicable only for the requirement of the retained quantity of samples for Bioavailability and Bioequivalence studies under the 21CFR, part 320.38(C).
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This policy addresses a requirement of retaining a sufficient quantity of reserved samples to permit the FDA to perform five times all the released tests required in the application or supplemental application.
It also describes the condition under which the agency does not generally intend to take enforcement action against an applicant or Contract Research Organization (CRO) for retaining less than the quantity of the reserve sample of the test article and reference standard that were used in BA and BE studies as specified under 21 CFR 320.38(C).
FDA does not take any action for violation of 21CFR 320.38(C) against NDA or ANDA applicant (or its CRO), if the sufficient quantity retains for all agencies testing and if best practices of compliant policy company follows.
Also Read:
USFDA regularly publishes new guidance for industry to maintain compliance in the pharmaceutical industry.
USFDA has controls on industrial compliance through various
guidance documents and manufacturing approval of the new drugs for the USA.
Recently in August 2020, USFDA has published a compliance policy is named as:
"Compliance Policy For The Quantity Of Bioavailability and Bioequivalence Samples Retained Under 21CFR 320.38(C)"
This policy is applicable only for the requirement of the retained quantity of samples for Bioavailability and Bioequivalence studies under the 21CFR, part 320.38(C).
7 basic factor for cleaning validation
This policy addresses a requirement of retaining a sufficient quantity of reserved samples to permit the FDA to perform five times all the released tests required in the application or supplemental application.
It also describes the condition under which the agency does not generally intend to take enforcement action against an applicant or Contract Research Organization (CRO) for retaining less than the quantity of the reserve sample of the test article and reference standard that were used in BA and BE studies as specified under 21 CFR 320.38(C).
FDA does not take any action for violation of 21CFR 320.38(C) against NDA or ANDA applicant (or its CRO), if the sufficient quantity retains for all agencies testing and if best practices of compliant policy company follows.
Also Read:
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