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Factorytalk is the first pharmaceutical service provider in Thailand to offer GMP audits for excipients and Active Pharmaceutical Ingredients of medicinal products (called API audit). Working on behalf of pharmaceutical manufacturers, Factorytalk's experts conduct audits on your behalf to ensure that your suppliers worldwide are producing materials in accordance with the rules of good manufacturing practice (GMP) for active pharmaceutical ingredients. With Factorytalk, such a third party audit obtains maximum impartiality and is performed at a level expected by internatational regulations (PIC/S, US FDA), Contact us for more information.

FAQs

What are Factorytalk's GMP Inspection costs?

The costs for an  GMP inspection are related to the necessary inspection extent. Typical inspection costs are in the range of 100,000 to 200,000 THB. Example: 140,000 for a 2-Day audit of API manufacturer in the EU inclusive of all costs and expenses.

What is the regulatory framework for a GMP inspection of Factorytalk?

Our inspections are generally conducted based upon guideline ICH Q7. Further applicable laws, regulations, standards, guidelines pharmacopoeial monographs can be included.

What is the educational and professional background of a Factorytalk GMP inspector?

Factorytalk inspectors exhibit at least 10 years of professional experience including formal training for auditors and/or registration as EU Qualified Person.