GMP News

Since 2005, the ICH Q9 Guideline has been the state of the art when it comes to quality risk management. It was initially included in the EU GMP Guidelines as Annex 20 and was then incorporated into Part III. In addition, an ICH Q9 "briefing package" was developed and made available on the ICH website. New training material is now also available for Revision 1 of the ICH Q9 Guideline.

The Drug Supply Chain Security Act (DSCSA) outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. In this article, you will find a summary of recent developments.

Chapter 2 of the EU GDP Guidelines defines the qualification requirements, tasks and responsibilities of all staff and the Responsible Person (RP). In this article, you will find a checklist to verify the minimum implementation.

The EMA recently announced that the Heads of Medicines Agencies (HMA), the European Commission (EC) and the EMA have published for the first time electronic product information (ePI) for selected human medicines harmonized across the European Union (EU). Does this mean the end of the printed package leaflet?

The European Commission (EC) published an updated Version 6.6 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). Amongst others, a new question on radiopharmaceuticals has been added.

Two pharmaceutical companies had received a Warning Letter from FDA without ever having been inspected on site. This was purely on the basis of a remote evaluation.

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. Beside a whole series of general GMP violations, the authority in particular blames the company for failing to test the incoming component benzalkonium chloride (BZK).

Following the previously pre-published Ph. Eur. Cannabis Flower Monograph and the announced Ph. Eur. CBD Monograph, four new Ph. Eur. cannabis reagents are needed for quality control purposes. The description of these Cannabis reagents will be published in the European Pharmacopoeia (Ph. Eur.) Supplement 11.5.

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 13: A cloud service providers refers to SOC reports when assessed, especially to the SOC2 report. Would this report be sufficient as concerns the requirements of the assessment and could it be used?

The U.S. Food and Drug Administration (FDA) has sent a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. Based on a review of record, the authority found several CGMP violations. These concern inadequate identity testing of incoming components and finished drug products. Furthermore, an adequate stability testing program was not implemented.

The EMA has launched a dedicated website for the Accelerating clinical trials in the European Union (ACT EU) initiative.

Even three months after its entry into force, Annex 1 still raises many questions. Swissmedic has now published a document with technical interpretations of existing questions under the title "Interpretation of GMP Annex 1 2022 (Rev. 1)".