GMP News - Quality Assurance

27.06.18

Batch Release without a QP - Is this possible?

Batch certification by a QP is one of the essential requirements in the EU GMPs. However one company in Spain has released products to the market without the QP - with reasonable consequences.

more

27.06.18

Brexit: Two new Documents published by EMA

The European Medicines Agency (EMA) has published two updated documents on U.K.´s withdrawal from the EU - giving a lot of new Questions and Answers on Brexit.

more

27.06.18

No second chance for a first impression - inspection result by a European supervisory agency

The Maltese competent authority has performed an initial inspection at the facility of an Indian manufacturer and packer in March 2018. This resulted in a Non-Compliance Statement regarding GMP.

more

27.06.18

MHRA´s Data Protection Policy

The MHRA published its data protection policy on May 25, 2018, the same day the new General Data Protection Regulation came into force in Europe.

more

20.06.18

MRA: New Q&As published

The European Medicines Agency (EMA) has published an updated set of questions and answers on the impact of the MRA between the EU and the US addressing questions with GMP relevance.

more

20.06.18

Quality defects: EMA updates Defective Product Report Template

The European Medicines Agency (EMA) has updated their document for reporting quality defects in drug products. Read more about the updated "Defective product report template".

more

14.06.18

Fertility Drugs stolen in Italy

More than 16.000 packages of fertility drugs were stolen in Italy when a truck was hijacked.

more

13.06.18

MRA with FDA: Two new States accepted

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

more

13.06.18

Manufacturing without process validation and stability testing - the quickest way to receiving a warning letter

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.

more

06.06.18

More Desktop Assessments - less Inspections?

A new PIC/S Guidance can help Competent Authorities (CA) prioritising resources for GMP inspections. It also serves as a model for the pharmaceutical industry for their risk based supplier qualification activities.

more

06.06.18

New Warning Letter calls for Risk Assessments

In a recent Warning Letter, the U.S. Food and Drug Administration FDA explicitly asks the company to perform risk assessments.

more

01.06.18

EU Data Protection Regulation - Impact on Clinical Trials & Pharmacovigilance

The EU Data Protection Regulation will apply from May 25, 2018. It will introduce new data protection requirements in the EU as well as substantial fines for breaches of the data protection rules. Read more about impact of the new EU Data Protection Regulations on clinical trial and pharmacovigilance activities.

more

30.05.18

Unexpected deviation: what is the Role of the QP?

The European Medicines Agency (EMA) has updated its Questions and Answers Section with an amendment to further clarify the role of the QP in the context of handling unexpected deviations.

more

30.05.18

How inspectors get trained in QRM

The PIC/S and the US FDA have set up a seminar to show inspectors how to assess Quality Risk Management implementation in industry.

more

30.05.18

Handling and shipping of IMPs

The European Medicines Agency (EMA) published a draft guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs. Read more about the proposed guideline which lays down the principles for the two-step release and shipping of IMPs.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics