GMP NEWS 2017

Even 17 years after the publication of the ICH Q7 Guideline, some companies still manufacture without complying with the most important binding GMP instructions and recordings. Read more about what minimal GMP requirements FDA inspectors expected but couldn't find at Changzhou Jintan Qianyao.

The revised general chapter <771> Ophthalmic Products-Quality Tests has been published. Read more about USP chapter <771> describing quality tests for opthalmic dosage forms.

EU/EEA inspectors performed almost 2.300 GMP inspections last year. In these inspections they found an increasing number of Non-Compliance Statements.

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.

The USP proposes two new general chapters <665> and <1665> to address the qualification of polymeric components used in the manufacture of pharmaceutical and biopharmaceutical APIs and drug products. Chapter <665> was previously published as Plastic Components and Systems Used in Pharmaceutical Manufacturing <661.3>. Read more about the proposals for Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products and Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products.

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.

Revised USP general chapters <660> and <1660> have been published for comment in the Pharmacopeial Forum. Read more about the drafts for Containers-Glass and Evaluation of the Inner Surface Durability of Glass Containers.

In the course of an FDA inspection at a Brazilian manufacturer of antibiotics, the inspector observed a few serious GMP violations which led ultimately to a Warning Letter. Read more about the FDA Warning Letter issued to the company Antibioticos Do Brasil Ltda.

On 12 April the European Medicines Agency (EMA) has released a draft guideline on good clinical practice (GCP) compliance in relation to Trial Master Files (TMF) for public consultation. The guideline is part of the work related to the implementation of the new Clinical Trial Regulation (EU) 536/2014. It also contains the revised version of the reflection paper on TMF, considering comments collected during public consultation. Read more about the Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.