Dear Sir,
We have a query regarding the APQR.
We are from cosmetic industry, pls confirm whether the APQR required or not for cosmetic products?
Apart from this suppose we are manufacturing more than 200 batches of a product, than how many batches we need to take for APQR.
Pls also confirm whether we can prepare APQR for random products or we need to prepare for each product.
Regards,
Ravi Yadav
It is always preferred to perform APQR whether it is a regulatory requirement or not.
APQR (Regular periodic review) of all authorized medicinal (or cosmetics) products should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, to highlight any trends, and to identify product and process improvements. Such reviews should normally be conducted and
documented annually, taking into account previous reviews as well.
The manufacturer and, where different, marketing authorization holder should
evaluate the results of the review and an assessment made as to whether corrective
and preventive action or any revalidation should be undertaken, under the
Pharmaceutical Quality System. There should be management procedures for the
ongoing management and review of these actions and the effectiveness of these
procedures verified during self-inspection. Quality reviews may be grouped by
product type, e.g. solid dosage forms, liquid dosage forms, sterile products, etc. where
scientifically justified.
Please note that all the batches of a product manufactured during the specified period (usually 12 months) should be considered for APQR. This will include QA-approved and Rejected batches and also reworked, reprocessed batches of that product.
There should be an internal SOP on APQR.
PIC guideline is used for preparation of APQR SOP
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