The GMP directive is dead - long live the GMP directive. It was with this phrase that new kings were announced in France in order to demonstrate the monarchy's continuity. But what about content consistency between the old and the new directive? What are the differences between both GMP directives? What will change in the new GMP directive, what will stay the same?
Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Companies will be better informed now, as well.
European GMP Inspector discovers Cleaning and Process Validation Deficiencies
It's a well-known fact that the US FDA publishes GMP deficiencies in their Warning Letters. For some years now, there has also been a European portal, where non-compliance results are published. In August 2017, an Upper Bavarian supervisory agency has issued such a statement of non-compliance with GMP to an Indian manufacturer of medicinal products. Which deficiencies were found?
The GMP world was turning a bit slower in 2016 - now, it's picking up speed again. Currently, several crucial changes are being made with consequences even for national legislation.
The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website. Read more about ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.
Changes in ECA Foundation and European QP Association Advisory Boards announced
With the resignation of Richard M Bonner as Chairman of the Advisory Board of both the ECA Foundation and the European QP Association (EQPA) the organsation has announced changes in the Advisory Boards of the ECA Foundation and the EQPA.
New FDA Guideline on Product Classification - what is a Drug, what isn't?
The new FDA guideline titled "Classification of Products as Drugs and Devices and Devices and Additional Product Classification Issues: Guidance for Industry" describes how the FDA classifies products as drugs, medical devices or other.
When Britain leaves the EU, the European Medicines Agency (EMA) will have to move as well. The final decision where to was made by drawing the name of the new EMA location out of a hat. How could that happen?
The European Medicines Agency (EMA) has updated its Q&A section on the Mutual Recognition Agreement. These questions mainly refer to the start of the operating phase of the MRA on 1 November 2017.
MRA: FDA now recognizes EU Inspectorates in 8 of 28 countries
Since 1 November, the MRA has been in the operational phase. The FDA now recognizes EU inspectorates in 8 of 28 countries - the majority of countries is not yet recognized.
The EU Commission published two new GMP documents in the Official Journal of the European Union. Learn more about the GMP Directive 2017/1572 for medicinal products for human use and the Delegated Regulation 2017/1569 on GMP for investigational medicinal products (IMPs) and requirements for inspections.
Frequent GMP Violations in pharmaceutical Companies (1): Testing and Release for Distribution
More and more frequently, FDA inspectors find fundamental GMP deficits at facilities producing finished medicinal products. The following analysis of recent warning letters shows that the final testing of pharmaceutical products for compliance with the specifications can not always be taken for granted.