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About Michael Anisfeld
Expertise
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
Experience
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UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
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You are here: Experts > Health/Fitness > Pharmacology > Pharmaceuticals > Raw material testing
Expert: Michael Anisfeld - 11/4/2009
Question
Reading guidelines about raw material testing for the pharmaceutical industry, I often find the word "appropriate" when it comes to how much we should test on each incoming batch and how often we should do the fully testing of the monograph in the Pharmacopeia.
We perform reduced testing on "well known" material after evaluating trends, audit, experiences with the manufacturer.
What would you recommend to be the minimum testing when we perform reduced testing?
How often should we do fully testing?
Would you differ on API and excipients regarding testing?
Looking forward to your answers.
Answer
The amount of testing is based on the supplier history and your confidence in the Supplier's Certificate of Analysis (gained by audits, comparative testing, etc.)
At a minimum full specification testing needs to be performed annually, but many companies perform full specification testing annually and on every 10th batch received from the supplier (some every 5th batch - again depends on usage, material criticality, confidence in the supplier, etc.).
Excipients needs to be minimally identity tested for each batch received (EU GMPs require identity for samples from every drum in shipment). Actives need, for every batch, to be identity and potency testing (EU GMPs - every drum).
I hope this helps.
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