Following the concept paper for updating the GACP guideline, the revised Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin has now been published. The document is open for comments until 15 July 2024.
APIC: Best Practices Guide for dealing with Suppliers
The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety.
The German federal states have cleared the way for the legalization of cannabis. The law came into force as planned on 1 April. What will change for medical Cannabis?
FDA Warning Letter: Missing Ongoing Stability Studies for APIs
In April 2024, the U.S. FDA issued a Warning Letter on its webpage to the Australian company "Antaria Pty. Ltd." after having inspected its site in November 2023. According to the Warning Letter the company missed to have an appropriate stability program for its API in place.
Did you know that EMA's Questions and Answers Section to Annex 16 further clarifies the role of the QP in the context of handling unexpected deviations?
Inspection results often help with the interpretation of regulatory requirements. The FDA Warning Letters are a very good source for that purpose. A recent Warning Letter criticises deficiencies in process validation. What did the FDA object to?
In March 2024, the ECHA (European Chemicals Agency) published the next steps of its working groups with regard to the restriction of "PFAS" (per- and polyfluoroalkyl substances) in Europe on its website.
Counter-Espionage Law: Do GMP inspectors no longer go to China?
As we reported at the end of last year, China has revised its counter-espionage law. Now there are fears that this will also affect GMP inspections and audits, as the German Handelsblatt writes.
FDA's current Thinking on KPIs and Quality Metrics
The FDA's current approach to monitoring pharmaceutical manufacturing emphasises the importance of quality metrics in ensuring product safety and efficacy. What is behind this?
US FDA: Draft on Data Integrity for BE/BA Studies published
At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.
Warning Letter to Chinese OTC Manufacturer: Violations concerning Identity Testing, Stability Program and Quality Unit
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products. The violations were identified during the FDA's review of records submitted by the company in response to an official request.
EDQM: Updated Information on the Quality Overall Summary (Module 2)
The revision 1 of the document "Quality overall summary (QOS) template for CEP applications", which was updated in January, has been published on the EDQM website. The document was first published in 2015 and is intended to provide assistance for CEP applicants.
APIC Quality Agreement Guideline: Update published
The first version of the document "Quality Agreement Guideline & Template" was published in 2009, updated in 2017 and has now been revised again. Version 3 of the guideline was published in January 2024 and is now available on the APIC website in the "Publications" tab.
EU Non-Compliance Report issued after insufficient CAPA
A recent EU Statement of Non-Compliance with GMP contains significant observations and requires the inspected company to carry out a detailed analysis, particularly with regard to CAPA.