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Pharmaceuticals/Scope of reprocessing for the drug products

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Question
Dear Anisfeld-san,

Could you interpret the scope of reprocessing for the drug products?

When any cosmetic defects were found on a primary package (PTP sheet) and/or a secondary package (carton), then the re-packaging was conducted.

Shall we recognize the above situation as the reprocessing?

Thank you in advance.

Best regards,
Ryota

Answer
Dear Ryota:

"Reprocessing" strictly applies to the need to reprocess the finished dosage form (the actual tablet, the actual bulk cream, etc.). It does not apply to the packaging situation you have described.

What you have is a deviation for using a secondary packaging material that does not meet specification. Your investigation needs to figure out how this oat-of-specification packaging material was approved by QA/QC and allowed to get to the packaging line.

I hope this helps.

Pharmaceuticals

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Michael Anisfeld

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Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

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