GMP News 2017

New Analysis of GMP Inspections by MHRA

The British MHRA has published the 2016 GMP inspection deficiency data trend. The report lists interesting examples for all relevant chapters and annexes of the EU-GMP Guidelines.

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USP Q&A Paper on Pharmaceutical Water

The website of the US Pharmacopoeia (USP) comprises a document with frequently asked questions and answers on the subject of pharmaceutical water. The not very well known page contains some very interesting points.

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FDA Warning Letter due to incorrect Certificates of Analysis

At the beginning of March 2017, Lumis, an API manufacturer in China, received a Warning Letter from the the US FDA. During the FDA inspection the certificates of analysis (COAs) were criticized. The issued certificates did not contain all relevant information on the quality that would have been necessary for the customer. Learn more about the FDA Warning Letter issued to Lumis.

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Impurities: Top 10 Deficiencies in New Applications for Certificates of Suitability

The EDQM has recently published a list of the top 10 deficiencies found in CEP applications.Find out how to avoid undesired inquiries from the EDQM on impurities in starting materials, elemental impurities and residual solvents in the framework of an application procedure.

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European QP Association Survey on the Certification of Batches with GMP Issues

To ascertain the information required by QPs to allow release of medicinal products impacted by a statement of non-compliance, the European QP Association (EQPA) performed a survey among its members. This survey on the certification of batches with GMP issues generated some interesting results.

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Packaging: Pharmeuropa Draft Chapters regarding PVC

In Pharmeuropa 29.2 several drafts of general chapters regarding packaging components and materials made of PVC have been published for comment. Read more about the drafts on materials and containers based on plasticised poly(vinyl chloride).

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Frequently Asked Question: How often does a Reverse Osmosis have to be sanitised?

Reverse osmosis as a main barrier to all types of impurities plays an essential role in both the production of Purified Water (PW) and cold WFI production. In the pharmaceutical industry, this module has to be heat sanitisable. Now the question is how often heat sanitisation has to be performed?

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Three-year period for implementation of USP Plastic Packaging Chapters <661.1> and <661.2>

The USP Expert Committee Packaging and Distribution decided to provide a three-year period for implementation of the requirements specified in General Chapters <661.1> and <661.2>. Read more about the revison regarding USP General Chapters Plastic Materials of Construction and  Plastic Packaging Systems for Pharmaceutical Use.

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EU GMP Non-Compliance Report might lead to FDA Import Stop in future

The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn't conclude though that the inspection pressure would decrease now because of the recognition of EU inspections. Read more about the consequences of the GMP Inspection Agreement.

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PQR: a common Misunderstanding when it comes to Starting Materials

It seems that there are some misinterpretations with Chapter 1.10 of the EU-GMP Guidelines, according to a blog entry of the British MHRA.

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Use of Hoses in the Pharmaceutical Industry

Hoses are more often used than one thinks. On the one hand they are used in routine operations, on the other hand they can also be utilised as interim solution before a new pipe is drawn. They then fall into the first case situation. While one pays more consideration to pipes, their material quality and surfaces, hoses are often neglected. But what about requirements for hoses? Are there any?

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EMA: Revised Summary of the relevant Guidelines for SmPC

The EMA has published a revised version of its list of relevant guidelines with regard to the contents of an SmPC. Read more about the document entitled "Scientific guidelines with SmPC recommendations".

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Suspension of medicines due to unreliable studies from two research labs in India

The EMA recommends the suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs. Medicines where suitable alternative data are available can remain on market. Read more about the press release regarding medicines recommended for suspension.

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GCP - Implementing Regulation on Inspection Procedures

The Implementing Regulation (EU) 2017/556 has been published in the Official Journal of the European Union on 25 March 2017. Read more about the details set regarding good clinical practice inspections of clinical trials.

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The MRA with FDA - any Consequences for the QP?

On 2nd March 2017, the US FDA and the European Medicines Agency (EMA) informed that they concluded a so-called MRA (Mutual Recognition Agreement). Learn more about the FDA-EU MRA and the consequences for the Qualified Person (QP).

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EMA's new Guideline on the Implementation of the ICH Q3D Guideline in the EU

Recently published, the EMA Guideline on the implementation of the requirements of the ICH Q3D Guideline provides support for API and medicinal product manufacturers. Learn more about what you have to consider with regard to the justification and documentation of elemental impurities in the dossier for a marketing authorisation.

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EMA revises Guide on Pharmaceutical Water

According to the European Pharmacopoeia, it is allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods. Now, the European Medicines Agency EMA has published a concept paper on the revision of the "Note for Guidance on Quality of water for pharmaceutical use".

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Recognition of Alternative Compendia (BP/EP/JP) by the FDA

In January 2017, FDA's Office of Pharmaceutical Quality revised the document "MAPP 5310.7" on the acceptability of standards from alternative compendia. This important FDA document is often unknown among the pharmaceutical industry. Learn more about the most important aspects of FDA's document "Acceptability of Standards from Alternative Compendia (BP/EP/JP)".

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QP Declaration: Revised Questions and Answers

The Co-ordination group for Mutual Recognition and Decentralised Procedures - human (CMDh) of the Heads of Medicines Agencies has revised its Question and Answers Document on the QP Declaration.

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New CMDh Q&A Document on the Implementation of the EU Falsified Medicines Directive

In March the CMDh published a new Q&A document to provide further guidance on the implementation of the EU Falsified Medicines Directive. Please find more information about the "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

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Warning Letter for Japanese Sterile Manufacturer

Insufficient environmental monitoring as well as inexistent smoke studies on a RABS (Restricted Access Barrier System) resulted in a Warning Letter for the Japanese manufacturer Sato Pharmaceutical Co. Ltd.

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API mixtures and CEP Procedure: What should be considered?

It is also possible to apply for a Certificate of Suitability for API mixtures. However, a few particularities have to be considered. Here, you can read about what must be observed when applying for a CEP for an API/auxiliary substances mixture or an API/antioxidant mixture.

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Validation vs. Verification of Medical Devices - An Interesting FDA Warning Letter

It its cGMP regulations for medical devices (21 CFR 820 (Quality System Regulations), the FDA also addresses the topic of validation (21 CFR 820.75). In the course of its inspections, the authority reviews the validation of the manufacturing processes. The FDA criticised according deficiencies at a Taiwanese medical devices manufacturer with a Warning Letter.

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MHRA Guideline on Re-Manufacturing of Single-Use Medical Devices

Last year the MHRA published a 11-page guidance about the re-manufacturing of single-use medical devices (SUDs). Alhough only valid for the UK the content of the MHRA Guidance on Single-Use Medical Devices is interesting.

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EMA Concept Paper on Combination Products

Since February, 16th 2017 you can comment on a concept paper of the EMA on the development of a guideline with regard to the quality requirements of "combination products" - called "Drug-Device-Combination" (DCC) in the document.

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