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Saturday, December 21, 2024

What are the GMP Requirements for Consultants?

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 FDA warning letters, the FDA sometimes advises the employment of a consultant in order to remedy the deficiencies addressed. But what are t...

Update in ICH Q8,Q9,Q10

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The ICH Secretariat announced the publication of the updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers (R5) related to ICH Q9(R1) Qu...

FDA 483 in QRA n Process Validation

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The topic of "risk" appears 16 times in FDA's Process Validation Guidance. Annex 15 to the EU GMP Guidance clearly states: ...
Friday, December 13, 2024

European Shortages Monitoring Platform ESMP Live

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The European Shortages Monitoring Platform (ESMP) has gone live with a core set of functionalities. Using this first version of the ESMP, ma...
Wednesday, December 4, 2024

What happens if the CSP does not allow audits

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The trend in the pharmaceutical industry is also moving towards cloud computing. Financial but also organizational advantages speak for the ...

Updated GDP Guide for Excipients

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In October 2024, the IPEC (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl) announced on its website the new versi...
Monday, December 2, 2024

Batch Production and Control Record discarded Unexo Lifesciences, India.

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Torn batch production records were found in plastic bags on the rooftop. These included missing batch production records, which allegedly co...
Friday, November 22, 2024

Pest Activity, Water Leaks, and Misuse of QC Laboratory in U.S. Drug Manufacturing Facility

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On 29 October 2024, the U.S. Food and Drug Administration (FDA) has published a Warning Letter dated 21 October 2024. The document goes back...
Tuesday, November 5, 2024

FDA announces Experiential Learning Site Visit Program

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The U.S. Food and Drug Administration (FDA) is announcing the Fiscal Year 2025 CDER Office of Pharmaceutical Quality (OPQ) Experiential Lear...
Tuesday, October 29, 2024

Root Cause Analysis: What can be found in FDA Warning Letters?

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corrective action and preventive action (CAPA) according to your procedure until after FDA cited your firm. Bell International Laboratories,...