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.
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.
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.
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.
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.
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.
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.
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.
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.
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>.
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.
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.
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."
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.
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.
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.
After the FDA moved towards a life cycle approach with its Process Validation Guidance in 2011, the EU GMP Guide now followed with the revision of Annex 15, also moving to modern process aspects (e.g. life cycle approach). But how can the industry implement the new process validation requirements? The ECA's Good Practice Guide on Validation does provide answers.