GMP NEWS 2018

In a press release from 22 June 2018 the International Council for Harmonisation (ICH) has announced that they will prepare new topics for the future that are of great importance for the pharmaceutical industry. The Council intends to begin developing the ICH Guidelines Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14)" and "Continuous Manufacturing (Q13)". Find out more about this important ICH Press Release.

The US Food and Drug Administration (FDA) has defined in a guidance how medicinal products need to be labelled in the USA if their packaging is child-resistant. Read here what information is required for child-resistant packaging.

There is not much time left until the safety features have to be implemented. These features are required to comply with the Falsified Medicines Directive, which will enter into force on 9 February, 2019. Meanwhile, a number of national data storage and retrieval systems have joined the EU Hub, as the European Medicines Verification Organisation (EMVO) reported.

The FDA has published a draft guidance which is to standardise the data traceability of products. Find out how long traceability data for products need to be stored according to the new FDA guideline "Standardization of Data and Documentation Practices for Product Tracing".

Data Integrity is still a hot topic in GMP inspections. And in the GDP area data integrity is also increasingly becoming a subject, as some examples from the MHRA show.

A new draft EMA Guideline requires that GDP-Guidelines for medicinal products should be taken into consideration for IMP shipments.

There isn't much time left until the safety features required in the future will have to be implemented in order to comply with the Falsified Medicines Directive which will enter into force on 9 February, 2019. The German initiative securPharm has published a status report in this issue for the year 2018. Read more about the "securPharm Status report 2018".

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.