GMP News

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.

More

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).

More

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.

More

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.

More

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.

More

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.

More

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.

More

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.

More

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.

More

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.

More

New VDI Guidelines for Barrier Systems, Medical Devices and HVAC systems

In August, the Association of German Engineers (VDI ="Verein Deutscher Ingenieure") released three interesting VDI guidelines. The topics addressed are tightness of containment systems, identification of critical impurities in the manufacturing process of medical devices as well as requirements on the planning and implementation of central HVAC systems. Find out more about the new VDI guidelines.

More

"Ambient", "Room Temperature", "Cold " - what is what?

What are the regulatory requirements behind "ambient", "room temperature" and "cold chain"? The answer to the meaning of different storage conditions is not that easy.

More

Clinical studies: new timeline for EMA portal

The EMA has published the estimated roadmap of important IT projects. This includes, inter alia, the initial application date of the EU portal for clinical studies. The application had originally been scheduled for the second half of 2019. Now, the initial application is supposed to be possible in 2020.

More

Sponsor Oversight of Clinical Trials - How to improve compliance?

There is no "one size fits all" for the management of clinical trials. However, there is a clear requirement according to GCP that the sponsor retains all responsibility for the conduct and reporting of clinical trials. So, how can the adequate sponsor oversight be ensured?

More

New Q&As on Chapter 3 of the EU-GDP Practice Guide (Premises and Equipment)

The European GDP Association has published new Question & Answers on Chapter 3 of the EU-GDP Guide (Premises and Equipment).

More

Regulatory Expectations for Contract RPs

For some wholesalers, the concept of using an external Responsible Person might be useful. But there a few things which need to be considered.

More

Will the CTR be implemented in UK in case of a "Hard Brexit"?

The UK Government has released advice regarding the consequences of the Brexit on clinical trials.

More

FDA´s draft Guidance on Post-approval Changes to APIs

API manufacturers who want to make changes to the API manufacturing process during an application's post-approval period should read FDA´s new draft guidance for industry: Postapproval Changes to Drug Substances.

More

CMDh Clarifications on the Implementation of the Falsified Medicines Directive

In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

More

New Questions and Answers on Safety Features - EU Q&As Version 10 published!

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. Get more details about the revised Q&A document of the EU on safety features.

More

What are FDA's Expectations from Contract Manufacturers?

In a four-page Warning Letter to a contract manufacturer who produces semi-solid OTC products, the FDA criticizes amongst others the missing tests of starting and finished products.

More

Serious GMP Deficiencies at Italian Sterile Manufacturer

On the basis of a GMP inspection performed at an Italian sterile manufacturer, the Italian authority (AIFA) recommended the recall of batches and issued a GMP non-compliance report. Read more about the GMP deficiencies observed.

More

Microbiological Environmental Monitoring in the Focus of an FDA Warning Letter

The topic microbiological environmental monitoring was one of the main focuses of an FDA Warning Letter. Read more about the deviations listed in the FDA Warning Letter issued to the Taiwanese company Taiwan Biotech.

More

FDA Warning Letter to Indian manufacturer due to an insufficient OOS procedure

In July 2018 the US FDA issued a Warning Letter to an Indian sterile manufacturer. The content of the letter primarily affects the inadequate procedure with OOS results. Besides, further deviations like in the visual inspection and the facility maintenance have been criticized.

More

Non-Compliance Report for Indian API manufacturer

During an inspection in March 2018, the French competent authority discovered various GMP violations at the site of an Indian manufacturer. Learn more about the Non-Compliance Report issued on behalf of the EMA.

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