GMP NEWS 2016

German Company receives FDA Warning Letter for Data Integrity Issues

On 16 May 2016, the FDA issued a Warning Letter to the German APIs manufacturer BBT Biotech GmbH. Read more about the deviations discovered with regard to computerised systems and data integrity.

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ECA Visual Inspection Groups works on new FAQ Document

The advisory board of ECA's Interest Group for Visual Inspection is working on a revision of a document with frequently asked questions with regard to visual inspection of parenterals.

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Current Issues of GDP Oversight

Since the publication of the EU GDP Guideline in March 2013 various measures for GDP oversight have been taken. While comprehensive measures exist in the area regulated by the EU GDP guidelines, there still are areas where oversight is insufficient or where diverse interpretations raise questions and issues. Read more here about GDP monitoring.

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GDP Non-compliance Report issued in EudraGMDP

The competent authority of the Czech Republic entered in total three GDP non Compliance Report into the community database. While GMP Non-Compliance Reports are entered frequently, reports about GDP compliance issues are not published very often. Please read more about GDP Non Compliance Reports.

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FDA releases new internal policy on ICH Q8, Q9, Q10 Guidelines

On May 18, 2016, the US Food and Drug Administration (FDA) released a new policy document on applying ICH Q8, Q9, and Q10 principles to chemistry, manufacturing, and controls review. Read more on how agency staff in the Office of Pharmaceutical Quality (OPQ) should apply the recommendations in the ICH Q8, Q9 and Q 10 guidelines to CMC reviews.

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Final WHO Guidance Document on Good Data and Record Management Practices

The WHO has just released the  the final version of the important guideline "Good Data and Record Management Practices".

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Indian API Manufacturers remain in the Focus of European GMP Inspectors

Some time ago three Non-Compliance Reports have been published in quick succession in the EudraGMDP database. Those reports deal with inspections performed at pharmaceutical APIs production sites located in India. Read more about the fundamental violations of the requirements for GMP-compliant API manufacturing in those facilities.

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Revision of the general Chapter on Pharmaceutical Water in the US Pharmacopoeia

The 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopoeia <1231> Water for pharmaceutical purposes.

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Case Study - Quality Metrics at Aenova: Report from the Pharma Congress 2016

Quality Metrics are a hotly-debated topic. At the end of July 2015, the U.S. FDA released a Draft Guide entitled "Request for Quality Metrics - Guidance for Industry". On the occasion of a keynote presentation at the Pharma Congress 2016, Dr Andreas König - Senior Vice President at Aenova - talked about the practical implementation and the challenges. Read more about Aenova's case study.

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New Definition for Auxiliary Medicinal Products (AMPs)

The EU Commission has launched four public consultations on recommendations related to clinical trials. One of them defines IMPs and Auxiliary Medicinal Products (AMPs) (previously called Non-Investigational Medicinal Products - NIMPs).

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QP Declaration for IMPs: some Questions and Answers

The MHRA Inspectorate has published a set of Question and Answers on the import of Investigational Medicinal Products (IMPs) in a blog.

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EMA reviews approvals based on data of Semler Research Centre Private Ltd, Bangalore, Indien

On April 29, 2016, the European Medicines Agency (EMA) has started a review of approvals based on studies conducted at Semler Research Centre Private Ltd, Bangalore, India. Find out more about the EMA- referral concerning studies of Semler.

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EU agrees on new Rules for Medical Devices

In the aftermath of the PIP scandal (4957), the EU has been planning for a long time a tightening of the rules for medical devices. In future, two regulations for medical devices and in-vitro diagnostics (IVDs) will be created on the basis of the 3 existing guidelines for medical devices (plus a supplement). How does the agreement of the EU look like?

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FDA: Current Publications for Medical Devices Manufacturers

From time to time, the ECA publishes overviews of new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Please read more about the FDA publications of the last months.

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MHRA publishes Guideline on Borderlines with Medical Devices

When is a medical device considered a medical device and when isn't it? The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) tries to answer this question in a 12-page guideline. Here you can find a summary of the MHRA guideline "Borderlines with medical devices".

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EDQM's Annual Report 2015: 18% of the sites inspected were not GMP-compliant

An important part of the CEP procedure by the EDQM is the inspection of the site where the APIs are being manufactured. Read more here about EDQM's Annual Report 2015 containing information about the issuance of CEPs and about inspections done within the certification programme.

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TTIP: The End of FDA Inspections in Europe?

Would the implementation of TTIP bring an end to FDA inspections in the EU? This is discussed in the EU proposal for a respective annex on medicinal products.

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Current European Non-Compliance Report for an Indian API Manufacturer

Major deficiencies observed during GMP inspections are entered into the EudraGMDP database by the European monitoring authorities. There, you can find a current Non-Compliance Report issued by the Italian Medicines Agency for the Indian API manufacturer Krebs Biochemicals & Industries Ltd.

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WHO defines Requirements on Zones E and F

In May, the WHO published a draft guideline which describes the recommendations for ventilation systems used in the manufacture of non-sterile dosage forms. It also contains for the first time a definition for microbial requirements with regard to the zones E and F. Read more about the ventilation sytems recommendations.

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Results of a Survey on ICH Q3D "Elemental Impurities"

For most companies manufacturing APIs and pharmaceutical products, the implementation of ICH Q3D has a serious impact - as shown in a survey recently carried out by the ECA. Read more about the issues encountered by many companies regarding the assessment and control of elemental impurities and the kind of support they wish.

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