With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.
Most recently, PIC/S has published on their website a "Letter of Agreement between the EEA Heads of Medicines Agencies and the Pharmaceutical Inspection Co-operation Scheme". Read more on the objective of the PIC/S and EMA agreement.
In August 2016, the PIC/S published the draft of the Guideline "Good Practices for Data Management and Integrity". Here, organisational measures and controls are required to review and assure the effectiveness of the internal data governance system. Read more about the PIC/S requirements for the pharmaceutical data governance systems.
The U.S. Pharmacopeial Convention (USP) proposes the revision of general chapters regarding the biocompatibility of materials used in pharmaceutical packaging systems, medical devices and implants. Read more about the suggested modernization of general chapters <87> Biological Reactivity, In Vitro, <88> Biological Reactivity, In Vivo, and <1031> The Biocompatibility of Materials used in Drug Containers, Medical Devices and Implants.
As a consequence of significant GMP violations, the US-American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Learn more on the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd.
There are many new developments and change notifications in the GMP area keeping the pharmaceutical industry busy, not least because many of the new requirements must be implemented soon. Read moe in our GMP Update Part 2.