Corona: UK expands QP Discretion

Annex 16 of the EU-GMP Guidelines (which is still valid in the UK) states that a “QP may consider confirming compliance or certifying a batch where an unexpected deviation concerning the manufacturing process and/or the analytical control methods from details contained within the MA [Marketing Authorisation] and/or GMP has occurred“. However this will only be possible […]

Home Office: is a remote Release possible?

Due to the current Sars-CoV-2 outbreak, more and more people started working from home; this includes Qualified Persons (QPs). But what do the regulators say when it comes to batch certification? A recent publication of MHRA in their blog is addressing an often discussed topic whether a Qualified Person (QP) is allowed to perform batch certification from home (“remote […]

Brexit: New Notice to Stakeholders

In the current Corona crisis, some people tend to forget that we are facing another challenge this year: Brexit. The leave of the UK will also affect pharmaceutical industry. Both EU Commission an EMA have now published a new Notice to Stakeholders “Withdrawal of the United Kingdom and EU Rules for medicinal Products for human […]

Travel Restrictions: Are Remote Audits an Option?

One of the tasks required by GMP regulations, which is also a part of business continuity for Marketing Authorisation Holders and so-called contract givers, is to qualify suppliers and contract acceptors. One important part of such a qualification process is the performance of an on-site audit. Because of the Corona crisis, the fact that an auditor […]

EU GMP Annex 21 finally published

On 20 March, after some delays, the new Annex 21 to the EU-GMP Guidelines was published as a draft. The document is entitled “Importation of medicinal Products”. The “Concept Paper” was already published on 13 May 2015 (EMA/238299/2015) and the consultation phase ended in August 2015. The first draft for regulatory consultation was published in November 2016. […]

EMA on potential Impact of Coronavirus

The European Medicines Agency (EMA) and its partners in the European medicines regulatory network are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the European Union (EU). A first meeting of the EU Executive Steering Group on shortages of medicines caused by major events was organised […]

European QP Association announces Change in IMP Group Leadership

As the Group’s management informed the EPQA’s Board, Philippe Van der Hofstadt resigned end of 2019 – after seven very successful years and excellent work. “We would like to extend our heartfelt thanks to Philippe for his outstanding service to the board and his untiring contribution to the success of the organization” Dr Susanne Ding […]

Brexit: MRA will be needed soon

Three European Industry Associations (EFPIA, Medicines for Europe and AESGP) have published a “Call for a Mutual Recognition Agreement on Good Manufacturing Practice (GMP) in the Context of Ambitious and Comprehensive EU-UK Future Relationship Negotiations“. In this paper, the associations state that “EU and UK should have the closest possible relationship for pharmaceuticals, prioritising the […]

Annex 1: Consequences for the QP

On February 20, the long-awaited revised draft of Annex 1 (Manufacture of Sterile Products) was published. The revised Annex 1 will not be an independent EU document, but should also apply directly to the PIC/S guidelines. So the planned revision will replace the current versions of EU-GMP Annex 1 and the PIC/S document PE 009 -11 […]

Warning Letter for inadequate Batch Record Design and Review

The U.S. Food and Drug Administration (FDA) recently posted a Warning Letter sent to a US pharmaceutical company criticising their incomplete batch production and control records. For example, batch production records were missing critical production information on the coating and blending process. FDA now expects the company to provide “appropriately detailed master batch records that capture […]