GMP News - Validation

What is the FDA´s current thinking with regard to Modern Qualification and Validation? You will find out in a recent lecture from FDA Director Grace McNally.

During an inspection in March 2018, the French competent authority discovered various GMP violations at the site of an Indian manufacturer. Learn more about the Non-Compliance Report issued on behalf of the EMA.

The ECA set up a survey to find out to what extent qualification and validation programmes are integrated as actually made possible by the EU Annex 15 and the FDA Process Validation guide – and to what extent suppliers are involved. Read more about the Qualification/Validation Survey results.

In a five-page warning letter to an OTC manufacturer, the US Food and Drug Administration (FDA) criticises, inter alia, the missing program for continued  process verification.

The FDA published a draft guidance on Data Integrity in clinical studies of veterinary medicinal products to support new animal drug applications. Read more about the documentation of  Electronic Data Files and Statistical Analysis Programs.

If a company neglects basic GMP principles, it is not very likely for it to pass an FDA inspection. Read here, what violations concerning the testing of incoming materials, the final testing of finished products and the control of production processes lead to a warning letter.

Recently a post in the MHRA blog informed about common findings GCP Inspectors have seen across a number of recent inspections. Read more about Data integrity in Clinical Trials.