GMP NEWS 2021

The EMA has published two draft guidelines on the quality requirements for IMPs (small and large molecules). According to the Agency, the documents are to be seen in connection with the Clinical Trials Regulation (EU) No. 536/2014 which is expected to become applicable in January 2022.

PIC/S has developed an FMEA-based risk assessment for routine on-site inspections (Covid-19 Risk Assessment for National Routine On-Site Inspections).

USP´s General Chapters–Packaging and Distribution Expert Committee (GCPD EC) proposes to replace spectral transmission with spectral absorbance for amber glass containers based upon wall thickness.

In a recently published ruling, the Court of Justice of the European Union (CJEU) decided that a medicinal product not subject to medical prescription in one Member State may not automatically be placed on the market in another Member State. Rather, the medicinal product may only be placed on the market in a Member State if the competent authority of that Member State or the EU Commission has granted its marketing authorisation.

The European GDP Association, representing about 3.500 professionals from across the globe, has extended its Board. Alfred Hunt was invited to join the Advisory Board and accepted to take over the role as a Deputy Chair.

The 10th Edition of The International Pharmacopoeia is now available online. It contains recommended procedures for analysis and specifications for APIs and dosage forms.

Marketing authorisation holders in Europe must evaluate their chemically synthesised or biological medicinal products with regard to nitrosamine impurities and, if necessary, carry out confirmatory testing. Detection of nitrosamines has to be reported. Read more here about which templates must be used for reporting nitrosamine impurities.

The latest revision of the EMA's question and answer document on nitrosamine impurities in medicinal products includes clarifications of some important issues. Read more here about the requirements for reporting nitrosamine impurities to regulatory authorities and the current deadlines for this.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S), as the international association of pharmaceutical inspectors, published the long-awaited guidance document on data integrity on July 1, 2021. Read more about the contents of the document PI 041 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments".