GMP NEWS 2015

What are FDA's 2016 Priorities?

FDA's Center for Drug Evaluation and Research (CDER) has published an overview on the forthcoming priorities.

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Non Compliance Report in Radiopharmaceutical Manufacturing

The Italian Medicines Agency published a "Non-Compliance Report" on radiopharmaceutical manufacturing and a suspension of the manufacturing authorisation.

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Pharmeuropa - Comments concerning revised texts about Bacterial Endotoxins

In December the EDQM published the comments concerning revised texts of chapter 5.1.10. Guidelines for using the Test for Bacterial Endotoxins. Find out more about the scope and the added specific points in the Test for Bacterial Endotoxins Guideline.

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GDP Interpretation: German Associations publish a Position Paper on Temperature Deviations

Different associations of medicinal products manufacturers and wholesalers have published a position paper and forwarded it to the regulatory authorities. Read more about the position paper on temperature deviations during the transport of medicinal products.

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EMA publishes Principles for QR Codes

According to a current publication of EMA, QR codes can be put in the future on package leaflets and outter packaging. Now, this also applies to centrally authorised medicinal products. Find out more about the EMA Principles for QR Codes.

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Texts adopted by the Ph. Eur. Commission

The Ph. Eur. Commission adopts 28 new monographs during its 153rd session held on 17-18 November 2015 in Strasbourg. The Texts will be published in the 9th Edition of the Ph. Eur. and shall become effective on 1st January 2017. Find out more about the new and revised texts adopted by the Ph. Eur. Commission.

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Identification of Medicinal Products Standards will apply in six Months

The pharma sector must comply with IDMP standards in the EU region starting July 2016. This provides regulators with the means of easily comparing product data across regions and with different manufacturers.

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FDA Guide for Microbial Vectors used for Gene Therapy

In October, the FDA published recommendations on microbial vectors for the field of gene therapy. Read more about the guide draft "Recommendations for Microbial Vectors used for Gene Therapy".

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Statistics and Process Validation: current Findings of the FDA

The "new" FDA's process validation guideline has been effective since January 2011. One of the considerable changes made to the original validation guideline from 1987 was to put a significantly greater emphasis on statistics in the context of process validation. So far, relatively few inspection deficiencies had been observed by the FDA with regard to statistics. At a conference in September 2015 co-sponsored by the FDA, Grace McNally - Senior FDA official - reported about current "findings" which also address statistical problematics.

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Medical Devices Warning Letter Statistics 2015 - Process Validation again in the Top 5

In a recent news we reported about statistics of the FDA from the first half year 2015 with regard to Warning Letters addressed to medical devices manufacturers. Please read more about the current evolution of the top 5 list regarding medical devices for the complete fiscal year 2015 (1 October 2014 to 30 September 2015, as of 10 October 2015).

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The QP Declaration: some Questions remain open

More than one year after the final guidance on the QP Declaration was published, some questions remain open or are frequently asked by the stakeholders. The most important ones have been summarised in a CMDh document.

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New USP Chapter on Package Integrity become official

The USP has described the future requirements for the integrity of pharmaceutical packaging in the Pharmacopeial Forum 40(5). The New and revised chapters will become official on August 1, 2016 (USP 39-NF34 1S)  in form of 4 general chapters. Find out more about the new USP Chapters on the Integrity of Pharmaceutical Packaging.

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Draft Annex 17: Real Time Release Testing, Revision 1

A revised version of Annex 17 is in preparation. On 15 September 2015, a consultation was launched on a draft revised Annex 17: Real Time release Testing. The document is for consultation until 11 December 2015. Read more about the consultation on the EU GMP Guidelines, draft revised Annex 17 on the Real Time Release Testing.

 

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Revised USP Chapter <1790> on Visual Inspection published

After the long-awaited Chapter <1790> on visual inspection of injections was first published in the PF 41(1) as a draft the USP has now submitted a revised draft in the PF41 (6). Read more about the revised draft of the USP Chapter <1790>.

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ECA establishes new Interest Group on Pharmaceutical IT Compliance

The ECA Foundation has established various working and interest groups concentrating on different topics. To cover IT technologies with regard to international GMP requirements the Foundation now established a new Interest Group on Pharmaceutical IT Compliance.

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Medicinal Products stolen from Distribution Warehouses - an Increasing Risk

One of the main reasons for the revision of the EU GDP Guideline in November 2013 was securing the so-called supply chain from falsified medicinal products. A current case shows how important this new regulation is. Read more here about the robbery of medicinal products in a distribution warehouse.

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FDA extends comments for "established conditions" guidance

The FDA extends the comment period for the CMC Guidance Document on "established conditions". Comments are now due January 4, 2016. Find out more about the "Established Conditions: Reportable Chemistry, Manufacturing, and Controls ("CMC") Changes for Approved Drug and Biologic Products; Draft Guidance for Industry."

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New WHO Draft on "Good Data and Record Management"

Data Integrity as a topic has become one of the main focuses of the regulatory authorities. Mid-September, the WHO published a draft guidance for comment on this topic too. Read more about the WHO Draft Guidance on Good Data and Record Management.

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USP revises Chapter <1231> on Pharmaceutical Water

The Pharmacopeial Forum 41(5) comprising changes to the fundamental monograph on pharmaceutical water of the US-American Pharmacopeia <1231> Water for Pharmaceutical Purposes has been published for comments. Read more about the changes in the pharmaceutical water monograph.

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Draft of new Ph. Eur. Chapter "Co-Processed Excipients" published

A draft of a new Ph. Eur. chapter  "Co-Processed Excipients" has been published in Pharmeuropa 27.4 with deadline for comments on December 31, 2015. Find out more about the proposed requirements for co-processed excipients.

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