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GMP News

Detailed Analysis of the PIC/S Document 'Recommendations on Qualification and Validation' - Part I

Since September 2007, the PIC/S document PI 006 has been available in Version 3 ('Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation'). The revised Version 4 ('Recommendations on Qualification and Validation') will come into force on 1 October 2026 and significantly expands both its scope and level of detail. What is new?

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Poor Hygiene and Environmental Conditions - FDA Warning Letter

During an inspection, the FDA identified a whole series of breaches of the sterile manufacturing regulations, ranging from hygiene shortcomings and monitoring gaps to inadequate handling of deviations.

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Poor Airflow Visualisation at European Manufacturer of Sterile Veterinary Medicinal Products

A European manufacturer of sterile veterinary medicinal products has received a Warning Letter following an inspection in April this year. Among other issues, airflow visualisation, aseptic behaviour and media fill (APS) were criticised.

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