GMP NEWS 2016

FDA releases draft guidance on the use of comparability protocols for post approval changes

The US FDA released a draft guidance for industry "Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information". The guidances replaces the draft guidance published in February 2003. It provides recommendations on implementing postapproval changes through the use of comparability protocols (CPs). Read more about FDA´s draft guidance for industry "Comparability Protocols for Human Drugs and Biologics".

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Five new General Chapters in the European Pharmacopoeia on Genotoxic Impurities in Pharmaceutical APIs

During the manufacture of APIs as sulfonate salts, esters of sulfonic acid may develop in undesired chemical side reactions. Recently, five new General Monographs have been included in the European Pharmacopoeia which describe how to cope with these impurities. Read more about these genotoxic impurities and the possibility to control them thanks to risk assessments.

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ECA/PQG Working Group finalises GDP Interpretation Guide

Three new chapters of an interpretation of the EU-GDP Guidelines with temperature mapping templates have been published. Please read more about the new Guidance Chapters of the ECA/PQG Working Group.

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Position Paper on QP Qualification published

The German Qualified Person Association (GQPA) has developed a position paper with own proposals to help shape the requirements on the qualification of Qualified Persons.

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GMP/GDP: When will I be inspected by the Authorities?

Various competent authorities are performing inspections. But who is subject to such an inspection?

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New Details on the Revision of USP Chapter 1

As already reported, Chapter <1> of the US American Pharmacopoeia has been revised again. Find out more about the chapter on Injections and Implanted Drug Products (Parenterals)-Product Quality Tests.

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Ph. Eur. Draft General Chapter 5.24. Chemical Imaging

A draft for a new General Chapter "5.24. Chemical Imaging" has been published for comments in Pharmeuropa 28.2. Deadline for comments is June 30, 2016. Find out more about the proposed new Ph. Eur. general chapter 5.24. Chemical Imaging.

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European Non-Compliance Report on Data Integrity

The British authority MHRA has observed serious violations of data integrity at the Indian manufacturer Marksans Pharma Limited. Read more about the deviations with regard to data integrity.

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GDP: MHRA concerned about Supplier Qualification

In a recent blog, the U.K. Medicines and  Healthcare Products Regulatory Agency reminds companies to assure their supply chain integrity. To support stakeholders, a three step guidance is given.

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Q&A - Reducing the Risk of Transfusion-Transmission of Zika Virus

In addition to their Guidance on donor screening and deferral concerning the risk of ZIKA virus transmission, the FDA now published a Q&A documenmt to answer the common questions of blood establishments. Read more about the "Questions and Answers Regarding “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry”.

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Platelets for Transfusion - Bacterial Detection Testing by Blood Establishments

Currently, the CBER issued a draft guidance document on the bacterial testing of platelets intended for transfusion. The document is open for comments and should, when finalized, supersede the recommendation in regard to bacterial contamination testing in the document entitled “Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods”. Find out more in the draft "Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion".

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Monoclonal antibodies as similar biotherapeutic products - Draft Guideline

Biosimilarity of Monoclonal Antibodies - the WHO published a revised draft of their Guidelines on evaluation of monoclonal antibodies as 5 similar biotherapeutic products (SBPs).

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New Extensive Warning Letter for Indian Manufacturer of Sterile Medicinal Products - Part 1

Again, the US American FDA has issued a Warning Letter to a manufacturer of sterile medicinal products. Comprehensive and serious violations of GMP principles were observed at the Indian manufacturer Emcure Pharmaceuticals Limited. Part 1 of the News deals with the topic insufficient aseptic practices. Read more about the most significant deviations in the Warning Letter.

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ICH Q3D implemented in the European Pharmacopoeia: Revision of Two General Monographs with Regard to Elemental Impurities

Two general monographs of the European Pharmacopoeia have been revised and published for comment in the newest "Pharmeuropa" edition. Read more about what you will have to consider in future with regard to the control of elemental impurities in pharmaceutical preparations, APIs and excipients.

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The new Annex 16 is coming into Force

The new Annex 16 "Certification by a Qualified Person and Batch Release" will become effective as of 15 April 2016. The contents will reflect the coming state of expectations regarding the batch release.

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EDQM adopts revised monograph for WFI allowing non-destillation techniques

In a press release the EDQM has announced that the new monograph draft on Water for Injection (169) had been adopted. Read on to learn more about the production of WFI with membrane systems.

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Court Judgement: A Medical Product can not be Marketed Anymore if it has Left the Legal Supply Chain

The distribution channel and the storage of medicinal products have been strictly regulated since the introduction of the new EU Good Distribution Practice Guideline (EU GDP Guideline). Now, a German Court has decided a case in which a medicinal product had seemingly the quality required but had left the legal supply chain temporarily. Read more about the court judgement and the consequences for the GDP environment.

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QP Education and Qualification - What is needed?

We are frequently asked about the educational requirements in order to become a Qualified Person in Europe. Comprehensive educational modules are offered, especially in the UK. These training courses contain different topics like pharmaceutical law, Microbiology, Quality Management etc and require the trainee to take part in multiple courses over an extended period. But is this needed to become a QP in Europe?Read more about QP education and qualification.

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ECA/PQG Working Group publishes Chapter 8 of the GDP Interpretation Guide

A new chapter of an interpretation of the EU Good Distribution Practice Guide (GDP) has been published jointly by the ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG). Please read more about the new Chapter 8 of the GDP interpretation.

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New FDA Warning Letter for Ipca Laboratories in India

In January 2016, a medicinal product and API manufacturer in India received a Warning Letter from the FDA. Manipulations of both the GC and the HPLC analysis were discovered during the review of the audit trails. Find out more about the current Ipca Laboratories FDA Warning Letter.

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