GMP News - Inspections/Audits

Four more EU Member States were evaluated and accepted by FDA and will now benefit from the EU-US Mutual Recognition Agreement for inspections.

Manufacturing and Importation Authorisation holders must not change the terms of the authorisation without prior approval of the authority. But also other GMP related changes require notification to the national competent authority.

Over the past months, the ECA reported about the growing number of Warning Letters issued to Asian companies. A recent FDA Warning Letter resulted in a ban on imports for a Chinese manufacturer of pharmaceutical products.

The Federal Assembly has revised Art. 64a of the Therapeutic Products Act which regulates cross-border inspections. Read more about the changes in the Swiss Therapeutic Products Act.

The European Medicines Agency, EMA, has updated its page on Mutual Recognition Agreements (MRA). Read more about the Questions and answers on impact of EU-US mutual recognition agreement on marketing authorization applications and relevant variations.

Quite a few supervising authorities in the health care sector come for GMP inspections also to foreign countries. Here you can read what the Brazilian ANVISA and the Mexican COFEPRIS will expect.

EU/EEA inspectors performed almost 2.300 GMP inspections last year. In these inspections they found an increasing number of Non-Compliance Statements.