Who needs to review Batch Records?

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to do so? No, because this is not a requirement. Chapter 2 of the EU-GMP Guide (Personnel) states that a QP “must ensure that each batch has been manufactured and checked in compliance with the […]

UK: Public Consultation on new Clinical Trials Legislation and Impact on IMPs

With the start of the application of the EU CTR on 31 January 2022, the MHRA (UK Medicines and Healthcare products Regulatory Agency) has launched a public consultation on proposals for legislative changes for clinical trials (CTs). Due to the Brexit, the CTR is not (directly) applicable in UK.  UK requirements will remain unchanged pending completion of the consultation. However, the UK “will […]

Swissmedic specifies Requirements for GMP Certificates

For companies with a valid establishment licence for the manufacture of medicinal products and transplant products, Swissmedic issues GMP Certificates on request. GMP Certificates from Swissmedic show the date of the inspection on which the certificate is based. They do not contain an expiry date. However, in accordance with the practice for GMP Certificates in the EU database […]

Final Annex 21 published

The final version of Annex 21 to the EU-GMP Guidelines (“Importation of medicinal products”) has been published in EudraLex Vol. 4. The draft was already published for comments in March 2020. Approximately 200 comments were received from 17 stakeholder organisations. The new Annex will come into operation on 21 August 2022. What is the purpose of this […]

PIC/S revises GMP guide to reflect EU Clinical Trials Regulation

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised its good manufacturing practice (GMP) guide (PE 009-16, Annexes) to reflect the EU Clinical Trials Regulation 536/2014 (CTR), which came into application on 31 January 2022. In particular, Annex 13 of the PIC/S GMP guide, which relates to the manufacture of investigational medical products (IMPs), has been revised based on the EU GMP […]

Final EMA Guidelines on Quality Requirements for IMPs

The final EMA Guidelines (Rev. 2) on the quality requirements for pharmaceutical and biological investigational medicinal products (IMPs) have been released on the EMA website together with an overview of comments received on the draft guidelines published last year. The date of coming into effect was 31 January 2022, which is also the application date of the Regulation (EU) No. 536/2014 on clinical […]

Will the EU Concept of the QP spread the World?

Each holder of a manufacturing authorisation for medicinal products in Europe needs to name at least one Qualified Person (QP). The legal basis for the appointment of a QP is defined in the DIRECTIVE 2001/83/ relating to human medicinal products (and in DIRECTIVE 2001/82/EC relating to veterinary medicinal products). These directives clearly determine the educational background […]

EU: Strengthening the EMA

A regulation strengthening the role of the EMA in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU (Regulation (EU) 2022/123 “on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices”). The regulation will apply from […]

Version 4.1 of the Q&As regarding the Clinical Trials Regulation

The European Commission (EC) published an updated Version 4.1 of the draft Questions & Answers (Q&As) relating to the Clinical Trials Regulation (EU) No 536/2014 (CTR). The Q&As will enter into force together with the application of the CTR on 31 January 2022. However, certain sections of the Q&A document are still not yet complete and […]

Q&A Document on the QP Declaration revised

The CMDh* has revised and published its Q&A document on the QP Declaration. Mainly adjustments were made due to the new Veterinary Medicinal Products Regulation (EU) 2019/6. Also, in several answers a differentiation was made between human and veterinary medicinal products. Adjustments were also made to question 3 “When the only change in an updated CEP is […]