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.


FDA Import Alert for inadequate Inspection Management

An Indian drug manufacturing facility receives a Warning Letter and an Import Alert because FDA investigators were detained from doing their job properly.


USP Draft General Chapters on Plastic Components and Systems Used in the Manufacturing of Drug Products

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.


Recent FDA Warning Letter: Issues with Monitoring of microbiological Environments

Because of various severe GMP violations, the FDA issued a warning letter to an American manufacturer of wound disinfactants. The authority especially criticised deviations in monitoring of microbiological environments. Read the more about the Warning Letter to Aplicare from December 2016.


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.


European authorities' viewpoint on validation deficiencies

An article from April reported about the publication of inspection results by the British MHRA for 2016. Amongst other things, this publication addresses deficiencies concerning validation/qualification.


USP Draft Chapters on Glass Containers <660> and <1660>

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.


FDA Warning Letter: Visible Particles and Visual Inspection

During an FDA inspection at the Kansas-based company Hospira in mid 2016, the FDA encountered several GMP violations which resulted in a Warning Letter. The GMP deficiencies concerning visual inspection as well as the handling of distributed batches which were contaminated with particles even lead to the assertion that the company's process of manufacturing injectable products was out of control.


Warning Letter for Brazilian Manufacturer of Antibiotics

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.


New USP Draft Chapter <1168> Compounding for Phase I Investigational Studies

The USP republished a draft of a new General Chapter <1168> for public comment. Read more about the draft of <1168> Compounding for Phase I Investigational Studies.


GCP: EMA Draft Guideline relating to the Trial Master File

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.


EMA-FDA QbD Pilot Program Report

In April 2017 the European Medicines Agency (EMA) published the final report of its joint pilot programme with the United States (US) Food and Drug Administration (FDA) for the parallel assessment of sections of applications relevant to quality by design (QbD). Read more about the final Report from the EMA-FDA QbD pilot program.


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.


Nitrogen Use in pharmaceutical Production

Nitrogen often comes in contact with a product during manufacturing and is therefore relevant for its quality, especially when it comes to the manufacture of sterile products. Nonetheless, the use of nitrogen is significantly less specified than that of pharmaceutical water. Parameters and limits for nitrogen have to be defined by the pharmaceutical users themselves.


USP Draft Chapters on Elastomeric Closures <381>, <382>, <1381> and <1382>

Four USP draft chapters on elastomeric closures have been published for comment in the Pharmacopeial Forum 43(3). Read more about the proposed USP general chapters <381>, <382>, <1381> and <1382>.


Now Official: Revised USP Plastic Packaging Chapters <661.1> and <661.2>

The revised USP General Chapters <659>, <661>, <661.1> and <661.2> are online available and have become official on May 1, 2017. Read more about the revisions of the four USP general chapters.


FDA Warning Letter due to incorrect HPLC and UV Data

In January 2017, Sato Yakuhin Kogyo Co. Ltd., a pharmaceutical company in Japan, received a Warning Letter from the FDA. During the FDA inspection, incomplete data were criticized in the HPLC and UV analysis. Find out more about the FDA Warning Letter issued to Sato Yakuhin Kogyo.


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.


Requirements for compressed Air in the Pharmaceutical Industry

In many cases, gaseous media used such as compressed air contact the product and are thus, by definition, quality relevant, and in particular, of course, in the case of sterile products. However, compared to e.g. the liquid medium pharmaceutical water, they are much less explicitly specified. Pharmaceutical users have to define their requirements for compressed air themselves.


New Analysis of GMP Inspections by MHRA

The British MHRA has published the 2016 GMP inspection deficiency data trend. The report lists interesting examples for all relevant chapters and annexes of the EU-GMP Guidelines.


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