GMP News 2017

WFI obtained by non-distillation methods - What are the Next Steps?

The European Pharmacopoeia's revised monograph 169 on water for injection (WFI) will become effective by the 1st of April 2017. For the first time in Europe, a monograph will allow the production of WFI with other methods than distillation. But there are still unanswered questions, e.g. how to deal with HPW systems which have been already producing water with WFI quality. Read more about the revision of the Monograph on WFI.

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FDAs Draft Guidances of Compounding and Repackaging of Radiopharmaceuticals

The FDA published two draft gidelines on their current thinking on Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies as well as by outsourcing facilities.

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Draft USP Chapter <671> Containers - Performance Testing

A draft version of general chapter Containers—Performance Testing has been recently published in the Pharmacopeial Forum - and is open for comments until end of March.

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Warning Letter and Import Alert for Chinese Manufacturer

During an FDA inspection of a Chinese drug manufacturer, the inspector criticized serious and sometimes even bizarre GMP violations  Read more about the Warning Letter to the Chinese Manufacturer Baoying County Fukang Medical Appliance Co. Ltd.

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New FDA Guidance: When is a Product considered "Suspect"?

In December 2016, the FDA published a guideline setting specific requirements on how trading partners can identify suspect products and inform the FDA about them. Read more information about FDA's current document "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification" here in this News.

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Counterfeit Medicines in the Legal Supply Chain

The Drug Commission of German Pharmacists (AMK - Arzneimittelkommission) regularly informs about batch recalls - e.g. due to quality defects. Now, there have been more and more reports about batch recalls due to counterfeit medicines. According to a report of the German newspaper "Deutsche Apotheker Zeitung" edition 5/2017, the company axicorp Pharma is facing such a counterfeits case. Read more about it here.

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First Warning Letter Citation of new FDA Guideline on Contracts

After the Food & Drug Admininstration (FDA) published its final Quality Agreements Guidance end of last year, we now find the first citations in Warning Letters.

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Revised USP Chapter <1225> "Validation of Compendial Methods" approved

The United States Pharmacopeial Convention (USP) approved a revised version of general chapter Validation of compendial Methods. Read more about the Validation of Analytical Procedures.

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Inspection Findings in Supplier Qualification and Contracting

Supplier Qualification and Contracts are a hot topic in inspections. Some detailed examples of observations were published recently by the U.K. authority MHRA.

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Serious FDA Warning Letter issued to European Manufacturer of Sterile Drugs, Part 3 - Data Integrity

As a consequence of significant GMP violations, the American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Read more about the details concerning data integrity issues listed in the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd. 

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FDA Guidance for Blood Donations with regard to Ebola Virus published

In January the FDA published a guidance for industry on "Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus".

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FDA Draft Guidance on Labeling of Red Blood Cell Units with Historical Antigen Typing Results

On 17 January the US FDA published a draft guidance on "Labeling of Red Blood Cell Units with Historical Antigen Typing Results". It is now open for comments.

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Quality Metrics and the Way to Continual Improvement and Business Continuity

To remain 'regulatory compliant' and to ensure the continuity of product supply, systems and processes must be evaluated and the respective processes simplified and controlled. Important tools in this context are accurate Quality Metrics and Performance Indicators.

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What are the current GMP Inspection Initiatives?

The ICMRA has published a very interesting overview about the current global GMP inspection initiatives by the competent authorities. It also shows the various initiatives between the EU and FDA.

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Explosion of an API Manufacturing Site: Supply of Medicinal Products Endangered

In October 2016, a facility of the company Qilu for manufacturing the antibiotic Piperacillin exploded. This accident at one production site has led to serious consequences in Germany. Read more here about the reasons and consequences of the supply shortages.

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Written Confirmations - Does the procedure work as it should?

Since January 2013 all imported APIs need to be accompanied by a so called "Written Confirmation" (except a few countries with equivalent GMP standards like the US and Switzerland) which should confirm that the manufacturing site is working under GMP (ICH Q7). But how much does the system help to improve quality of APIs. An investigation of written confirmations issued by the Indian Authorities reveals some surprises. Read more about the Written Confirmations for APIs.

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Elemental Impurities: The Next Steps for the Implementation of ICH Q3D into the European Pharmacopoeia

The EDQM has published the next steps for the implementation of the ICH Q3D guideline in the European Pharmacopoeia. Read more here about the changes in the European Pharmacopoeia regarding the control of elemental impurities in different pharmacopoeia monographs.

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European Authority's Inspection Findings in the Area Validation/Qualification

The US American Food and Drug Administration (FDA) has long been publishing inspection results in so-called Warning Letters. Those letters are freely available on the Internet. Since a few years now, major violations of GMP have been published in a European inspection database. The British Regulatory Authority (MHRA) does this in a much more detailed way. Read the following examples published by the MHRA on the topic area validation/qualification from 2015.

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USP´s Intent to Revise and to Develop Elastomeric Packaging Chapters

The U.S. Pharmacopeial Convention (USP) proposes to revise its elastomeric packaging chapters. Find out more about these revisions of USP chapters <381>, <382>, <1381> and <1382>.

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New and Revised Draft GMP Guidances FDA is planning to publish 2017

FDA's CDER has published a Guidance Agenda with planned new and revised Draft Guidances for 2017. Some of the planned FDA Guidances could be interesting for the GMP area.

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PIC/S and European Medicines Agencies agree on Audit Cooperation

Most recently, PIC/S has published on their website a "Letter of Agreement between the EEA Heads of Medicines Agencies and the Pharmaceutical Inspection Co-operation Scheme". Read more on the objective of the PIC/S and EMA agreement.

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How important is "Data Governance" for your Company?

In August 2016, the PIC/S published the draft of the Guideline "Good Practices for Data Management and Integrity". Here, organisational measures and controls are required to review and assure the effectiveness of the internal data governance system. Read more about the PIC/S requirements for the pharmaceutical data governance systems.

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USP´s Intent to Revise Chapters on Biocompatibility of Packaging Systems and Medical Devices

The U.S. Pharmacopeial Convention (USP) proposes the revision of general chapters regarding the biocompatibility of materials used in pharmaceutical packaging systems, medical devices and implants. Read more about the suggested modernization of general chapters <87> Biological Reactivity, In Vitro, <88> Biological Reactivity, In Vivo, and <1031> The Biocompatibility of Materials used in Drug Containers, Medical Devices and Implants.

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Serious FDA Warning Letter issued to European Manufacturer of sterile Drugs, Part 2

As a consequence of significant GMP violations, the US-American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Learn more on the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd.

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GMP Outlook for 2017 (Part 2)

There are many new developments and change notifications in the GMP area keeping the pharmaceutical industry busy, not least because many of the new requirements must be implemented soon. Read moe in our GMP Update Part 2.

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