Missing Investigation of OOS Results leads to FDA Warning Letter

The API manufacturer Keshava received a Warning Letter from the FDA in March 2018. During the inspection, it has been criticised that no corrective actions had been taken for Out-of-Specification results and that a few analyses missed complete data. Read more here about the FDA Warning Letter for Keshava Organics.


Expectations of the British MHRA on Decontamination with Hydrogen Peroxide

Decontamination by means of vapour hydrogen peroxide is a well established procedure for isolators. Now, the question is what the expectations of the British Authority MHRA are with regard to sterilisation of direct and indirect contact parts in isolators. Andrew Hopkins - among others chairperson of the working group for the revision of Annex 1 - published his opinion on that.


Viral Safety of Blood and Plasma - FDA Guidance on HCV Testing

FDA published their recommendations for further testing if the result of a donor screening test for antibodies to the hepatitis C virus (anti-HCV) came out positive. These recommendations may be found in the draft guildeline on "Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus".


Revision: FDA Guideline on Adaptive Designs for Clinical Trials

In September, the US Food and Drug Administartion published a draft guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics. It is the revision of the existing guidance from 2010.


FDA Guidance on Efficient Clinical Trial Design Strategies for Cancer Drugs and Biologics

Relating to the increasing need of simultaneously evaluatation of more than one investigational drug and/or more than one cancer type in one clinical trial, the FDA published a new guidance on Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.


Version 11 of EU Q&As on Safety Features: Specific Questions on Stickers

The European Commission released version 11 of the questions and answers catalogue on safety features in September 2018. It also addresses the placing of safety features by means of stickers in detail. Get more information about safety features in the revised Q&A document of the EU.


Single-Dose, Multiple-Dose or Single-Patient-Use Container?

The FDA published a new guideline on the selection of the appropriate package type terms and recommendations for labeling injectable medical products packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.


Brexit: Insulin Stockpiles are built up

Pharmaceutical companies have started to build up stockpiles of lifesaving medications to be prepared for a hard Brexit.


USP Stimuli Article on the Correct Use of Mean Kinetic Temperature

Recording temperatures during transport of pharmaceutical products as well as calculating the mean kinetic temperature is essential for assessing a batch with regard to its quality status. How to avoid mistakes when calculating the mean kinetic temperature?


EMA clarification on the download of SARs from EudraVigilance

Due to inquiries concerning the handling of ICRs in EudraVigilance, the EMA has published a brief and structured clarification.


What to expect from GVP inspections?

The MHRA recently updated their Good Pharmacovigilance Practice (GVP) webpage on the MHRA website. In addition, the agency provided important things to know about GVP inspectors and GVP inspections.


Pharmacovigilance: Be prepared for "Hard Brexit"

The UK Government has released some information regarding the consequences of the Brexit on pharmacovigilance and the establishment of the Qualified Person for Pharmacovigilance (QPPV).


Ph. Eur. Draft on Depyrogenation of Packaging Materials

The EDQM published a draft for a new Ph. Eur. general chapter regarding pyrogen inactivation or removal from primary packaging materials and equipment. Read more about depyrogenation of items used in the production of parenteral preparations.


European Pharmacopoeia: New Chapter on Visual Inspection for Visible Particles

The European Pharmacopoeia has published a new chapter on testing of parenterals for visible, particulate matter in Pharmeuropa 30.4.


Frequent GMP Deficiencies at API Manufacturers reflected in Warning Letters - Current Trends

The Warning Letters sent to API manufacturers in the last few months are a source of comprehensive information. A detailed analysis of them unveils interesting facts and trends on GMP violations with regard to the handling of raw data, OOS results and data integrity.


Portugal now part of MRA with FDA

Portugal has been accepted by FDA and will now benefit from the EU-US Mutual Recognition Agreement for inspections.


How did the EMA Q&A Document on the use of PDE Values come about?

In June you could already read about the Q&As of the European Medicines Agency (EMA) on the use of PDE (HBEL) values in connection with cross contaminations and cleaning validation. The EMA has now published a report which describes how these questions and answers came into being.


Purpose of the ECA AQCG Guideline on Analytical Procedure Lifecycle Management

ECA's Analytical QC Group has developed a comprenesive Guideline on Analytical Procedure Lifecycle Management (APLM). Find more details about the purpose of this new and important ECA AQCG Guideline.


Version 10 of EU Q&As on Safety Features: Specific Questions on Bundle Packaging

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. The specific question of bundle packaging has also been addressed. Get more information about bundle packaging in EU's Q&A document on the safety features.


How FDA will prioritise Inspections

The US FDA has published a so called internal Manual of Policies and Procedures (MAPP) describing how the agency will prioritise its pharmaceutical inspections.


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