Since the publication of the EU GDP Guideline in March 2013 various measures for GDP oversight have been taken. While comprehensive measures exist in the area regulated by the EU GDP guidelines, there still are areas where oversight is insufficient or where diverse interpretations raise questions and issues. Read more here about GDP monitoring.
The competent authority of the Czech Republic entered in total three GDP non Compliance Report into the community database. While GMP Non-Compliance Reports are entered frequently, reports about GDP compliance issues are not published very often. Please read more about GDP Non Compliance Reports.
On May 18, 2016, the US Food and Drug Administration (FDA) released a new policy document on applying ICH Q8, Q9, and Q10 principles to chemistry, manufacturing, and controls review. Read more on how agency staff in the Office of Pharmaceutical Quality (OPQ) should apply the recommendations in the ICH Q8, Q9 and Q 10 guidelines to CMC reviews.
Some time ago three Non-Compliance Reports have been published in quick succession in the EudraGMDP database. Those reports deal with inspections performed at pharmaceutical APIs production sites located in India. Read more about the fundamental violations of the requirements for GMP-compliant API manufacturing in those facilities.
Quality Metrics are a hotly-debated topic. At the end of July 2015, the U.S. FDA released a Draft Guide entitled "Request for Quality Metrics - Guidance for Industry". On the occasion of a keynote presentation at the Pharma Congress 2016, Dr Andreas König - Senior Vice President at Aenova - talked about the practical implementation and the challenges. Read more about Aenova's case study.
The EU Commission has launched four public consultations on recommendations related to clinical trials. One of them defines IMPs and Auxiliary Medicinal Products (AMPs) (previously called Non-Investigational Medicinal Products - NIMPs).
On April 29, 2016, the European Medicines Agency (EMA) has started a review of approvals based on studies conducted at Semler Research Centre Private Ltd, Bangalore, India. Find out more about the EMA- referral concerning studies of Semler.
In the aftermath of the PIP scandal (4957), the EU has been planning for a long time a tightening of the rules for medical devices. In future, two regulations for medical devices and in-vitro diagnostics (IVDs) will be created on the basis of the 3 existing guidelines for medical devices (plus a supplement). How does the agreement of the EU look like?
From time to time, the ECA publishes overviews of new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Please read more about the FDA publications of the last months.
When is a medical device considered a medical device and when isn't it? The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) tries to answer this question in a 12-page guideline. Here you can find a summary of the MHRA guideline "Borderlines with medical devices".
An important part of the CEP procedure by the EDQM is the inspection of the site where the APIs are being manufactured. Read more here about EDQM's Annual Report 2015 containing information about the issuance of CEPs and about inspections done within the certification programme.
Major deficiencies observed during GMP inspections are entered into the EudraGMDP database by the European monitoring authorities. There, you can find a current Non-Compliance Report issued by the Italian Medicines Agency for the Indian API manufacturer Krebs Biochemicals & Industries Ltd.
In May, the WHO published a draft guideline which describes the recommendations for ventilation systems used in the manufacture of non-sterile dosage forms. It also contains for the first time a definition for microbial requirements with regard to the zones E and F. Read more about the ventilation sytems recommendations.
For most companies manufacturing APIs and pharmaceutical products, the implementation of ICH Q3D has a serious impact - as shown in a survey recently carried out by the ECA. Read more about the issues encountered by many companies regarding the assessment and control of elemental impurities and the kind of support they wish.
The Delegated Regulation of the EU has set the deadline for the implementation of the safety features which will be binding as of 9th February 2019. The European Commission has published the summary of a workshop to inform all stakeholders of the recent publication of this Delegated Regulation. Read more about the Workshop on the Delegated Act on Safety Features.