GMP News

New EU/EMA planned Actions in the Context of the COVID-19 Pandemic

The European Medicines Agency EMA has published three press releases on current EU/EMA activities in the context of the COVID-19 pandemic.

More

FDA Warning Letter: Violations of GMP Fundamentals in Quality Control and Manufacturing Process

A Warning Letter was inevitable when FDA inspectors found that even basic GMP requirements were not being met at a Chinese production site.

More

Evidenced Cross-Contamination at Indian Manufacturer results in Warning Letter

The FDA has recently issued a Warning Letter to a large Indian pharmaceutical manufacturer following an inspection that revealed poor cleaning and later detected cross-contamination in manufactured tablets. Further GMP violations were detected like leaking HEPA filters and inadequate smoke studies in the sterile area.

More

FDA Warning Letter to EU Company

Despite the MRA, FDA is still coming to the EU to inspect. Now a company from Bulgaria received a Warning Letter and was placed on Import Alert.

More

Remote Release and Remote Audits: New Answers from the EU

EMA, EC and HMA have created a Q&A document on regulatory expectations during the covid-19 pandemic. New questions and answers are dealing with remote audits and remote release.

More

Version 17 of the Q&As on Safety Features for Track & Trace

The European Commission has published Version 17 of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".

More

FDA Warning Letter: No Compendial Methods established? Develop appropriate Testing Procedures by yourself!

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Romania-based manufacturer of an unapproved new drug due to, among others, releasing drug products without conducting identity and strength testing.

More

What does "State of Control" mean for the FDA?

In the context of process validation, the FDA attaches considerable importance to a "state of control". The FDA expects evidence of this "state of control" as part of stage 3 "continued process verification" within the validation lifecycle. Now, what exactly does the FDA want to see? Parts of the answer to this question can be found in Warning Letters.

More

Corona: UK expands QP Discretion

The UK MHRA has published a Guidance for exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID-19) outbreak. This additional flexibility might sound reasonable but it will put a lot of additional responsibility on the QPs.

More

FDA Warning Letter: Incoming Analysis of Raw Materials - Performing only an Appearance Test is not enough

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Danish drugmaker for serious GMP violations, including inadequate testing of finished products. Furthermore, the company failed to conduct at least one test to verify the identity of each component of a drug product.

More

Warning Letter due to Non-Compliance with 3D Rule

A Chinese manufacturer has received a Warning Letter from the US-American FDA due to inadequate equipment design, deficiencies in monitoring and not performed laboratory tests as well as deficiencies in the Batch Record Review.

More

Warning Letter: Lack of Repairs at US-American Manufacturer

A US-American pharmaceutical manufacturer of OTC solutions and suppositories has received a Warning Letter from the US-American FDA due to non-executed repairs and deficiencies in cleaning and laboratory testing.

More

COVID-19: Temporary Regulatory Flexibilities for Wholesalers in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of temporary regulatory flexibilities on good distribution practices (GDP) that will be allowed to address the current exceptional circumstances during the coronavirus (COVID-19) outbreak.

More

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?

More

German Pharmacopoeia Monograph for Cannabis Extracts

The monograph "Cannabis Extract, Standardized" (Cannabis extractum normatum) will be added to the German Pharmacopoeia (DAB 2020).

More

How to handle Legacy Systems if no Audit Trail is available or a "User Login" is not possible?

The topic data integrity raises a multitude of questions. Current questions are addressed in a loose sequence of News. Question 7: How to handle Legacy Systems if no audit trail is available or a "user login" is not possible?

More

Brexit: New Notice to Stakeholders

EU has published a new Notice to Stakeholders on the withdrawal of the UK which summarises the most important aspects in three parts.

More

Travel Restrictions: Are Remote Audits an Option?

Because of the Corona crisis, the fact that an auditor has to visit a site currently presents a potential risk to all persons involved or might simply not be possible because of travel bans. What are the options now?

More

Shredding Key Documents and Leading Investigators to Incorrect Rooms - An unusual FDA Warning Letter

FDA Warning letters often refer to insufficient documentation, missing validations, inadequate training, employees not following procedures, or similar cases. But shredding documents and leading investigators to incorrect rooms during an inspection is rather unusual.

More

Coronavirus: FDA's Advice for the Donation of Cells, Tissue and Products Based on Them

By providing information on the safety of cell and tissue products in relation to coronavirus, the FDA gives support in questions of transferability by donors.

More

Serological Tests for HTLV Viruses by Blood and Blood Components

Testing for virus contamination plays an important role in blood and blood components. Recently, the FDA has published a guidance document on testing for T-lymphotropic viruses by means of serological testing.

More

Updated Recommendations for Reducing the Risk of CJD and vCJD by Blood and Blood Components

The FDA has revised its assessments and recommendations to reduce the possible risk of transmission of Creuzfeldt-Jakob by blood and blood products.

More

COVID-19: Beware of falsified medicines from unregistered websites

The European Medicines Agency (EMA) is urging the general public not to buy medicines from unauthorized websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic.

More

Falsified Medicines: MHRA publishes Class 4 FMD Medicines Information

The Medicines and Healthcare products Regulatory Agency (MHRA) is currently investigating an incident where several medicines appear to have left the legal supply chain.

More

Deadline Extended: EMA Informs about New Deadline for Risk Assessment on Nitrosamines

The European Medicines Agency, EMA, as well as the EDQM have extended their deadlines for submitting risk evaluations for Nitrosamine Impurities in medicinal products by the Marketing Authorisation Holders.

More

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK