GMP News - Quality Assurance

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.

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.

A new Non-Compliance Report was published on the EudraGMDP site leading to a suspension of the respective manufacturing authorisation.

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.

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.

Once again, the FDA has issued a Warning Letter to an Indian pharmaceutical manufacturer. Failure to fully investigate the scope and root causes of reported complaints and to take appropriate action regarding recalls of defective products were the main points of criticism. Find out more about the deficiencies in complaint and recall handling that resulted in a Warning Letter.