GMP NEWS 2018

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.

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"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.

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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.

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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?

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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).

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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.

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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.

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FDA´s draft Guidance on Post-approval Changes to APIs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

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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".

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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.

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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.

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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.

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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.

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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.

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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.

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Are you familiar with the Verification Guide ASTM E 2500?- ECA Modern Qualification Survey Results

Last week part I of ECA´s survey about "Modern Qualification" was published. In the following you will find further results of ECA's survey on modern qualification.

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FAT & SAT not frequently used as Part of Qualification - ECA Modern Qualification Survey Results

The ECA set up a survey to find out to what extent qualification and validation programmes are integrated as actually made possible by the EU Annex 15 and the FDA Process Validation guide – and to what extent suppliers are involved. Read more about the Qualification/Validation Survey results.

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Insufficient handling of data integrity and validation of analytical methods lead to FDA warning letter

Drug manufacturer Reine Lifescience received an FDA warning letter in May 2018. During the inspection, it was particularly criticised that the company could not provide data on the validation and verification of their analytical methods. The controls of their computerised systems have not been sufficient, either. Read more about the recent FDA warning letter to Reine Lifescience.

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Will UK accept EU QP Certification after a "hard" Brexit?

The UK Government has published a notice discussing the consequences for batch testing, QP certification and batch release with an interesting statement.

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FDA´s final Guidance on Elemental Impurities in Drug Products

The final FDA guidance provides recommendations regarding the required documentation related to the control of elemental impurities consistent with ICH Q3D and USP General Chapters <232> and <233>. Read more about FDA´s guidance on Elemental Impurities in Drug Products, which applies to manufacturers of noncompendial and compendial drug products.

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