GMP NEWS 2016

APIC is working on an enhanced ICH Q7 How to do Guide

Acting on the publication of the ICH Q7 Q&A Document in June last year APIC has decided to elaborate another revision of its "ICH Q7 How to do Document" taking into account these Q&As. Here you will get to know why this upcoming How to do Document is a valuable support for API and API intermediate manufacturers regarding the practical implementation of the ICH Q7 What to do principles.

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Effect of primary packaging on drug stability of solid dosage forms

In the Pharmacopeial Forum 42(4) [Jun-Jul 2016] a stimuli article on the effect of primary packaging on the drug stability of solid dosage forms has been published . Read more about The Effect of Primary Packaging on the Physical Degradation of Metformin, Lisinopril, and Simvastatin Solid Doses During Patient Use When Stored at Different Temperature and Humidity Conditions.

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New WHO guidance on variations to multisource pharmaceutical products

The World Health Organizaton (WHO) recently published a new Annex 10 on handling of variations. Find out more about the new WHO general guidance on variations to multisource pharmaceutical products.

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FDA - Blood Collection and Zika Virus in Florida

Related to some non-travel related cases of Zika virus, the FDA published a new "Advice to Blood Collection Establishments on Non-Travel Related Cases of Zika Virus in Florida".

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Proposals to revise EU Guidance on first-in-human Clinical Trials

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials.

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WHO Technical Report - GMP for Biological Products adopted

As a part  of their Technical Report Series with guidance documents comprising recommendations for biological products, the The World Health Organization (WHO) now published "Annex 2 - WHO good manufacturing practices for biological products".

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Updated Standards for Bioequivalence Studies: WHO publishes Revised Guidance for CROs

WHO's guideline for clinical research organisations performing in vivo bioequivalence studies has been extensively revised and recently published. Read more in the News about which requirements are now binding for CROs with regard to the QM system and electronic data management.

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ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process

The ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). This new ICH Guideline is proposed to provide guidance on general principles on planning/designing Multi-Regional Clinical Trials (MRCTs). Read more about the ICH E17 General Principles for planning and design of multi-regional Clinical Trials.

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FDA Guidance for Blood Donor History Questionnaires and Accompanying Materials

The US FDA implemented the updated Guidance for Industry Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components.

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European Commission: Draft Guideline GMP for ATMP open for stakeholder consultation

End of June, the European Commission issued a stakeholder consultation on the draft guideline Good Manufacturing Practice for Advanced Therapy Medicinal Products.

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EMA publishes Reflection Paper on Viral Safety of plasma-derived Medicinal Products with Respect to Hepatitis E Virus

The EMA published the final "Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus" after the completion of the accepted comments of the public consultation.

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EDQM Survey on new General Chapter on microbiological Control of Tissue

The European Directorate for the Quality of Medicines & Healthcare (EDQM) published a survey to gather information from relevant stakeholders for elaboration of a chapter on microbiological control of tissues.

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MHRA GxP Data Integrity Definitions and Guidance for Industry: New Draft Version for Consultation

In January and March 2015, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) published a "GMP Data Integrity Definitions and Guidance for Industry". The agency has recently published a new version of the Guidance. Please find here a short overview of the new features in the "GxP Data Integrity Definitions and Guidance for Industry: Draft version for consultation".

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WHO Draft on Analytical Method Validation

The World Health Organization (WHO) recently published a draft document on analytical method Validation for comment. Read more about the draft "Guidelines on Validation - Appendix 4 Analytical Method Validation".

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Written Confirmation expired: Can an API still be imported when produced earlier?

What needs to be considered if an API is produced in the time period of a valid written confirmation but imported after this confirmation has expired? This is answered in a revised Q&A Document of the EU Commission.

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Ph. Eur. Drafts on Rubber Closures (3.2.9) and Plastic Containers for Blood (3.2.3)

In Pharmeuropa 28.3 revisions of two Ph. Eur. general chapters on containers (3.2.9 and 3.2.3)  have been published for comment. Deadline for comment is September 30, 2016. Read more about the drafts for 3.2.9 "Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders" and 3.2.3 "Sterile plastic containers for human blood and blood components".

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EDQM announces revision of general chapter Monocyte Activation Test (2.6.30)

On 23 June, the EDQM in Strasbourg announced the revision of the pharmacopoeial general chapter 2.6.30 on Monocyte Activation Test.

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New Orientation for ECA Foundation RMM Working Group

The ECA Foundation's Rapid Microbiological Methods (RMM) Working Group was originally established in June 2006 at the Paul-Ehrlich-Institut (PEI) - the German Federal Agency for Vaccines and Biomedicines. Now the Foundation announced a new orientation for its RMM Working Group.

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Revision of BAM Chapter 23: Microbiological Methods for Cosmetics

In May 2016, the FDA published some revisions in the text of the Bacteriological Analytical Manual, Chapter 23, "Microbiological Methods for Cosmetics".

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Confused about the changes in EudraGMDP?

EudraGMDP is the European Database for GMP and GDP Compliance information. The database receives a lot of attention from industry because of the GMP and GDP Non-Compliance Reports. Now, the database has been changed without notice and has caused some confusion. Read more about the updated EudraGMDP Database.

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