GMP NEWS 2020

The updated version of the paperback "ICH Q7 Side-by-Side Comparison", which lists and compares the "ICH Q7 Guideline - GMP for Active Pharmaceutical Ingredients" with the "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" on GMPs for APIs, is now available.

In view of recent experiences from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) published a new working document entitled "GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS".

The French Ministry of Health has published the specifications and quality requirements for medical cannabis in the pilot phase. The document covers flowers, extracts and finished products for oral, sublingual and inhalation use (including devices).

To facilitate the rapid deployment of the vaccine the European Commission (EC) recently published a document regarding labelling and packaging flexibilities for COVID-19 vaccines.

The answer to this question is: It depends. Recently, medical cannabis grown in a non-EU-GMP-certified facility in Uruguay became available on the German market.

The U.S. Food and Drug Administration (FDA) has published the final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies".

Due to the deficiencies identified during an inspection that the FDA had already conducted in February 2020, an Indian pharmaceutical manufacturer has now received a Warning Letter. The main reasons for this were deficiencies in equipment design, validation and incoming goods inspection. Read more here.

The term Design Qualification is not used in the current FDA Guidance on Process Validation. However, it is addressed that the design of a facility plays a role within the scope of a qualification. Moreover, in a current Warning Letter the FDA criticizes design deficiencies in a water system.

When complying with the requirements of the Anti-Counterfeiting Directive, the status message "recall" for recalled batches is of great relevance for the entire supply chain. What has to be considered here?