GMP NEWS 2016

EDQM's new Guideline on Electronic Submissions for CEP Applications

As of today (June, 1st 2016), the EDQM doesn't accept any CEP application in paper format. Read more here about the structure of the electronic submission of an application for a Certificate of Suitability and the errors to avoid.

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EMA Inspections increased by 35%

The number of GMP inspections increased by 35% in 2015, according to the 2015 Annual Report of the European Medicines Agency EMA, which was recently published.

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WHO issues revised Guideline on HVAC Systems

The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems for the manufacture of non-sterile forms. As most guidelines on this topic address the requirements for sterile dosage forms, the previous version was gladly accepted by industry. Learn more about the revised guideline on HVAC systems.

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EU GMP Annex 1 Revision 2016 - what does the pharmaceutical industry expect?

Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at Boehringer Ingelheim talked in his keynote speech at the Pharma Congress 2016 about the revision of Annex 1 of the EU GMP Guide. Read here what the pharmaceutical industry expects form the new Annex 1.

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EMA publishes QPPV Update

The European Medicines Agency (EMA) published the first issue of  its new "QPPV Update". Find out what´s new in Pharmacovigilance.

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EMA publishes Reflection Paper on Off-Label Use for Comment

The Europeam Medicines Agency (EMA) has published a "Reflection paper on collecting and reporting information on off-label use in pharmacovigilance“ for comment (deadline July 29, 2016). Read more about EMA's reflection paper on Off-Label-Use.

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EMA post-authorisation procedural advice for users of the centralised procedure

The European Medicines Agency (EMA) recently published an updated Questions and Answers paper on post-authorisation procedural advice for users of the centralised procedure. 

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EMA publishes Q&A on data required for sterilized primary packaging materials used in aseptic manufacturing processes

The European Medicines Agency, EMA, recently published questions and answers on what data is required for sterilisation processes of primary packaging materials subsequently used in an aseptic manufacturing process. Read more about "What data is required for sterilisation processes of primary packaging materials subsequently used in an aseptic manufacturing process?".

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FDA´s new policy regarding grouping of supplements for CMC changes

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) released a new document outlining how supplements can be grouped together and submitted concurrently for the same chemistry, manufacturing and controls (CMC) changes. Find out more about Policy and Procedures regarding the Review of Grouped Product Quality Supplements.

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EMA's new Draft Guideline on the Sterilisation of Medicinal Products, APIs, Excipients and Primary Containers

For medicinal products administrated in sterile form, the process to reduce the microbial level is a critical manufacturing step with regard to quality. The EMA has recently published the draft of a guideline on that topic which contains a range of clarifications. Read more about the coming requirements on sterilisation of medicinal products, APIs, excipients and final containers and how to document them in the marketing authorisation dossier.

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EMA's Provisions regarding the Implementation of the Counterfeit Directive

The date for the implementation of the safety features is now mandatory through the EU Delegated Regulation:  February, 9th 2019. This new requirement will also have direct impact on the marketing authorisation of medicinal products. For this, the EMA has published an implementation plan for the introduction of the safety features.  Read more about EMA's new provisions.

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USP publishes draft of a new general chapter <661.3> for plastic components used in manufacturing

In the Pharmacopoeial Forum (PF)  42(3) (May-June 2016) the USP General Chapters - Packaging and Distribution Expert Committee proposes a new general chapter  <661.3> Plastic Components and Systems Used in Pharmaceutical Manufacturing and a revised version of general chapter <1661> Evaluation of Plastic Packaging and Manufacturing Systems and Their Materials of construction with Respect to Their User Safety Impact. Read more about USPs Proposal on Plastic Components and Systems Used in Pharmaceutical Manufacturing.

 

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EMA publishes finalised Process Validation Guideline for Biotech Products

Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been published under the title "Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission". 

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Extensive Warning Letter for Indian Manufacturer of Sterile Medicinal Products - Part 2

Again, the US American FDA has issued a Warning Letter to a manufacturer of sterile medicinal products. Extensive and serious violations of the GMP principles have been discovered at the Indian manufacturer Emcure Pharmaceuticals Limited. Part 2 of this News addresses environment and personnel topics. Read more about the most significant deviations in this Warning Letter.

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Quality Documentation of API mix in the Marketing Authorisation Procedure

For different reasons, the manufacture of APIs may sometimes require adding excipients. In the context of an authorisation procedure, this practice reveals to be problematic. Read more here about the data required for the quality documentation of a API mix in an ASMF or a CEP.

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FDA Warning Letter calls explicitly for CAPA

The US FDA has published a Warning Letter that clearly proposes some necessary actions and asks for appropriate corrective and preventive actions (CAPA).

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New FDA Guidance on "Safety by Design"

On April 11, 2016, the FDA released a new guidance on "Safety Considerations for Product Design to Minimize Medication Errors". The guidance provides a set of principles for using a systems approach to minimize medication errors relating to drug product design and container closure design to enhance patient safety. The recommendations in this guidance apply to the development stage of drug and biologic products. Find out more about the new FDA guidance on "Safety by design".

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EMA is starting a review concerning studies at Alkem, India

Following a good clinical practice (GCP) inspection at the Alkem Laboratories Ltd site in Taloja, India, which raised concerns regarding study data used to support EU marketing authorisation applications, the European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted at this site. Read more about the start of a review regarding study data generated at the Alkem Laboratories Ltd site in Taloja, India.

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New FDA Draft Guidance 'Data Integrity and Compliance with cGMP' published

In the last years, the topic "data integrity" has become a priority for the FDA. Recently, the Agency has published the draft of a Guidance for Industry on the topic which presents the comprehensive opinion of the FDA on data integrity. Read more about the draft of the Guidance for Industry "Data Integrity and Compliance with cGMP".

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European Non-Compliance Report due to the Lack of Transparency regarding the Sourcing of Starting Materials

This year in February, European GMP inspectors discovered critical GMP deficiencies at an Indian API facility. Read more about the lack of transparency of the supply chain, the insufficient documentation system and the lack of data about process validation at this site.

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