GMP News

During  2020, the FDA updated and expanded its series of guidelines on the topic of cell and tissue products with a revised version of the Guideline Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.

Recently, the FDA published a Q&A Paper on their website that answers the most common questions about the emergency approval of COVID-19 vaccines and explains the underlying process.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Mexican manufacturer. According to the FDA, the firm did not adequately validate the process and qualify the equipment used to manufacture the drug products. Furthermore, the company did not adequately test components prior to use in the manufacture of drug products destined for the US market.

A Task Force with members from the pharmaceutical industry, plant manufacturers and engineering companies has created the ECA Guide. The Guide was designed based on the requirements of EU GMP Annex 15 and supplemented by aspects of ASTM Guide 2500. The Annexes are very important for the applicability of the Good Practice Guide. They contain sample documents and templates that are successfully used in the pharmaceutical industry and in plant engineering and construction. Read more about the Guide in the GMP Journal Article.

Swissmedic inspections may be carried either out on-site, (partly) by means of remote assessments or at a later point in time.

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.