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.
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.
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.
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.
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".
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.
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.
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.
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.
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.