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Pharmaceuticals/cleaning validation

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Question
Dear Dr. Anisfeld
If i have a product that is produced on a dedicated line which is used only for that product...does this line need a spectial cleaning validation?
wish you anice day
M.A. Etman

Answer
Dear Mohammed:

No. if a production line is dedicated to a single product in a single strength, then no cleaning validation is required.

If multiple strengths of the same formulation (dose proportional) are being manufactured on the line, then perform minimal cleaning validation on the strongest formulation.

Ramadan Kareem

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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