GMP NEWS 2016

USP develops new General Chapter on Metal Packaging Components

The USP is currently developing a new general chapter on metal packagings. The proposed title of the new general chapter <662> is  "Metal Packaging Components and their Materials of Construction". Find out more about the developing process of the proposed general chapter on metal packaging components.

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GCP Inspection Findings published

The UK MHRA has compiled a GCP Inspections Metrics Report summarising 125 GCP Inspections.

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IMPs: Responses to the public consultations on new GMP Regulations published

Last year, the EU Commission has published four public consultations on investigational medicinal products (IMPs). The feedback is now available.

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EMA publishes GVP Module V (Revision 2) for public comment

Module V of the Guideline on Good Pharmacovigilance Practice (GVP) has been revised by the European Medicines Agency (EMA). Deadline for Comments is May 31, 2016. Module V covers the topic "Risk Management". Find out more about the revised GVP Module V.

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New FDA Guidance on Extent of Safety Data in Late Stage and Postapproval Clinical Investigations

On February 18, 2016,  the U.S. Food and Drug Administration, FDA, published a new Guidance for Industry on "Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations". Find out more about the new selective approach to safety data collection.

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ZIKA Virus - Reducing the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products

Related to the current issues with the ZIKA virus, the FDA published a new guideline about Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products.

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EMA Guideline on the clinical evaluation of Factor VIII products published

The EMA published the new Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products with necessary information when an application for a marketing authorisation for recombinant or human plasma-derived factor VIII products is made.

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ATMP - Monthly Report of the CAT January 2016

The CAT monthly report of the January meeting 2016 provides you with information about statistical data, classification of ATMP, scientific advice and more on ATMP. Read more about application procedures, guidelines and related documents on advanced therapies.

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FDA Draft Guidance on NAT tests to reduce the risks of HBV transmission from cells and tissues

Microbiological Safety of Human Cells, Tissues, and Cellular and Tissue-Based Products: FDA published a draft guidance on the "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus".

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New FDA Guidance on Completeness Assessements for Type II API Drug Master Files

Since 1st October 2012, special regulations have been applying to the US Type II Drug Master Files. This year in February, the FDA published a new Guidance for Industry. Read here what the DMF holder has to consider when submitting data about the API Drug Master File.

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USP proposes revision of general chapter <1225> Validation of compendial procedures: Adding a section on Life Cycle Management

The USP proposed a revision of chapter <1225> in PF 42(2) (March-April 2016). The proposal includes addition of a section on "Life Cycle Management of Analytical Procedures". Read more about the proposed revision of general chapter <1225> "Validation of compendial procedures".

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Second Revision of USP Chapter <1> Injections and Implanted Drug Products (Parenterals)-Product Quality Tests

After the revision of the General Chapter on quality testing of sterile medicinal products in the US American Pharmacopoeia had already been announced last year in the USP 38-NF 33, the USP is planning a new revision. Read more about the revision of Chapter <1>.

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Already 13 EMA GMP Non-compliance Reports in 2016 published

EudraGMDP is the central database for GMP and GDP compliance. Inspections which have been performed by any of the EU member state inspectorates are published in the database. Please get the details about the GMP non-compliance findings at 11 manufacturers in Europe and abroad.

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ECA publishes Code of Practice: The Responsible Person for GDP

A Task Force initiated by the ECA Foundation has developed a Guidance document which aims to support Responsible Persons (RPs) for Good Distribution Practice (GDP).  Please read more about the Code of Practice for RPs.

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Non-Compliance Reports for European Manufacturers of Sterile Medicinal Products

The Spanish and the Polish competent authorities have currently published two Non-Compliance Reports because of major deviations in the manufacturing of sterile medicinal products. Read more details about the new Non-Compliance reports.

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What are the Rules for Supplier Qualification?

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements for qualifying suppliers?

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FDA Guideline on Dissolution Testing

The FDA has presented the draft of a revised guideline on dissolution testing for immediate release. Under certain conditions, the tests can now be standardised. Read on to get more information about FDA's Guideline on Dissolution Testing.

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Chinese Heparin Manufacturer again involved in Falsification and GMP Non-Compliance

The Heparin Scandal has changed the regulation and the enforcement actions against API manufacturers like no other case in the last 20 years. Now, it seems that falsified Heparin was detected again at a manufacturer in China. Read more about the background of the Heparin case and the GMP Non Compliance Report issued in EudraGMDP for Dongying Tiandong Pharmaceutical.

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Fraud and Major GMP Violations at API Manufacturers in India and China

Two Non-Compliance reports to API manufacturers from the Far East  published in the EudraGMDP database reveal once more that basic requirements laid down in the ICH Q7 Guideline are not implemented. Read more details about those Non-Compliance Reports.

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Minutes of the HMPC Meeting Published

On 2 February 2016, the EMA published the comprehensive minutes of the HMPC Meeting on 23-24 November 2015. Herein, you can find a lot of information about the work of the HMPC in the past year. Read more about the HMPC meeting last November.

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