GMP News - Quality Assurance

The US Food and Drug Administration (FDA) announced that it accepted four new states, which will now benefit from the EU-US Mutual Recognition Agreement MRA.

The first inspection of an Indian pharmaceutical company ended with the worst imaginable result. Read more about the GMP violations found by the European inspectors with regard to documentation management, cleaning and process validation, as well as further violations of GMP basic requirements.

An inspection by EU inspectorates in collaboration with EDQM has revealed significant GMP violations at a Valsartan manufacturer's site.

Validating blend uniformity is a decisive factor for the validation of solid dosage forms. In Europe, there are no regulatory provisions for this. This is different in the USA: the 21 Code of Federal Regulation (CFR) 211.110 requires the regular assessment of the adequacy of mixing.

Because of Brexit, the European Medicines Agency (EMA) further needs to reduce activities. However some EMA acitivities will continue as planned.

The EDQM published a draft for a new Ph. Eur. general chapter regarding pyrogen inactivation or removal from primary packaging materials and equipment. Read more about depyrogenation of items used in the production of parenteral preparations.

The US FDA has published a so called internal Manual of Policies and Procedures (MAPP) describing how the agency will prioritise its pharmaceutical inspections.