The decision of the U.K. to leave the EU has caused a high uncertainty throughout industry - and also in the pharmaceutical industry. The European QP Association has received a number of questions on what Brexit actually means for QPs. For that reason the EQPA leadership team has prepared some information.
EMA reviews Medicines manufactured at U.S. Company
Following the issuance of two Non-Compliance Reports for two sites of the US based company, EMA has started a review of medicines manufactured by Pharmaceutics International Inc., USA.
The FDA has published a supplementing Guide on Quality Metrics. This is a very unusual step as the contents of the guide are planned to be integrated into the Guideline on Quality Metrics which hasn't been finalised yet. Read more about the Technical Quality Metrics Guide.
The US FDA has published a Warning Letter that clearly proposes some necessary actions and asks for appropriate corrective and preventive actions (CAPA).
FDA releases draft guidance on the use of comparability protocols for post approval changes
The US FDA released a draft guidance for industry "Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information". The guidances replaces the draft guidance published in February 2003. It provides recommendations on implementing postapproval changes through the use of comparability protocols (CPs). Read more about FDA´s draft guidance for industry "Comparability Protocols for Human Drugs and Biologics".
The German Qualified Person Association (GQPA) has developed a position paper with own proposals to help shape the requirements on the qualification of Qualified Persons.
The new Annex 16 "Certification by a Qualified Person and Batch Release" will become effective as of 15 April 2016. The contents will reflect the coming state of expectations regarding the batch release.
We are frequently asked about the educational requirements in order to become a Qualified Person in Europe. Comprehensive educational modules are offered, especially in the UK. These training courses contain different topics like pharmaceutical law, Microbiology, Quality Management etc and require the trainee to take part in multiple courses over an extended period. But is this needed to become a QP in Europe?Read more about QP education and qualification.
The past year was a quite eventful year - with new GMP developments as well as with announced changes. This year won't be less exciting, also because now many of the new requirements must be implemented; and also novelties have to be expected. In this news, we have compiled an outlook.
The previous year 2015 was another eventful year. Again there were new developments in the GMP environment as well as announcements of changes that preoccupied the pharmaceutical industry. Read more in our overview about GMP regulations in 2015.
Best Practice Guide for Quality Agreements published
The Rx-360 Supplier-Led Working released a Best Practices for Quality Agreements Guide aiming to identify best practices as well as common sense solutions to the quality agreement process.
Identification of Medicinal Products Standards will apply in six Months
The pharma sector must comply with IDMP standards in the EU region starting July 2016. This provides regulators with the means of easily comparing product data across regions and with different manufacturers.