GMP News - Quality Assurance


Brexit: the British comment

After the European Medicines Agency EMA in particular spoke out on the possible future of the trade with medicinal products on European Union level, the British now provide some input - e.g.. about the role of the Qualified Person (QP). Read how the Britisch imagine the trade with medicinal products in the future.



Inspectorate clarifies Responsibilities and Duties of the IMP QP

In the manufacturing and release of IMPs, not all requirements of Annex 16 can be transferred one to one. MHRA is now trying to clarify the most important questions.



Brexit: EMA prioritises Activities

The European Medicines Agency (EMA) expects some uncertainty and higher workload because of the Brexit. Now, the EMA has defined three categories to prioritise activities in a business continuity plan.



The MRA between Japan and EU will be extended

The Mutual Recognition Agreement on GMP products (MRA) between the EU and Japan will soon be amended to include APIs, biologics, and vaccines.



FDA Warning Letter for inadequate Batch Record Review

The US Food and Drug Administration (FDA recently posted a Warning Letter for a Chinese API manufacturer criticising the quality unit for not exercising its responsibility adequately.



Swissmedic specifies Requirements for RPs

The current edition of the Swissmedic Journal 05/2017 and the Technical Interpretation I-SMI.TI.17 specify the requirements with regard to the independence and the obligation of presence of the Swiss QP.



APIs from UK will need Written Confirmation

As indicated, a series of Questions and Answers on the Brexit will be provided by the EMA and the European Commission. Now, EMA has published a first set of these Q&As on Brexit.



FDA´s Office of Regulatory Affairs restructured

FDA´s main task is to protect public health. Therefore, the FDA has to keep pace with new developments in sciences and globalisation. To keep this pace the FDA has set up an alignment programme.



Brexit: U.K. will become 'Third Country' according to EU Statement

The EU Commission and EMA made a clear statement that after 30 March 2019, the Unit Kingdom will become a 'third country'. Both expect marketing authorisation holders to prepare accordingly.



Managing Deviations and CAPA still in the focus of the Inspectorates

Deviations and CAPA remain hot topics in inspections. This can be seen in a report published by the MHRA early this year and in a recent Warning Letter from FDA.



How to inform EMA about GMP Problems or Data Integrity Issues

On 17 March 2017 the European Medicines Agency (EMA) released a new policy on the handling of information which has been received from external sources about serious concerns, e.g. related to GMP deviations or Data Integrity issues. Please read more about the EMA policy.



European QP Association Survey on the Certification of Batches with GMP Issues

To ascertain the information required by QPs to allow release of medicinal products impacted by a statement of non-compliance, the European QP Association (EQPA) performed a survey among its members. This survey on the certification of batches with GMP issues generated some interesting results.



PQR: a common Misunderstanding when it comes to Starting Materials

It seems that there are some misinterpretations with Chapter 1.10 of the EU-GMP Guidelines, according to a blog entry of the British MHRA.



The MRA with FDA - any Consequences for the QP?

On 2nd March 2017, the US FDA and the European Medicines Agency (EMA) informed that they concluded a so-called MRA (Mutual Recognition Agreement). Learn more about the FDA-EU MRA and the consequences for the Qualified Person (QP).



QP Declaration: Revised Questions and Answers

The Co-ordination group for Mutual Recognition and Decentralised Procedures - human (CMDh) of the Heads of Medicines Agencies has revised its Question and Answers Document on the QP Declaration.


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