GMP News - Analytical Quality Control


Specifications and Acceptance Criteria for Impurities: new FDA Principles!

The FDA's Office of Pharmaceutical Quality has published a new MAPP document (Manual of Policies and Procedures) on acceptance criteria and specifications for impurities. In provides principles on the determination of specifications and acceptance criteria for non-mutagenic impurities in authorisation applications, based on clinical relevance. Read more about the Office of Pharmaceutical Quality's new FDA document.



FDA Inspection leads to Import Ban

A company in Canada had sourced products from a supplier who was listed on FDA Import Alert. Therefore, the FDA declared an immediate import ban in this company, as well. Find out more about the FDA Warning Letter to Aztex Enterprises.



Regulatory requirements for Audit Trail Reviews

Audit Trails and their reviews are an important requirement in the current GMP policies. Specific requirements can be found in a number of guidelines, these days. Despite that, many questions about the specific implementation of this complex topic into practice remain. Read more about the EU, PIC/S and FDA requirements concerning Audit Trails and their reviews.



USP proposes additional changes to <1090> Assessment of Drug Product Performance

Additional changes to the USP general chapter <1090> have recently been proposed by the USP General Chapters—Dosage Forms Expert Committee. Read more about the revision of USP chapter Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution.



Revision of USP chapter on NIR

Besides IR and Raman, NIR is frequently used in the inspection of incoming active ingredients and excipients. New suggestions for updating the two NIR chapters were issued in the USP's Pharmacopeial Forum. Please find more information on the changes to the USP chapters <856> and <1119> on near-infrared spectroscopy.



Ph. Eur. Monograph on Rubber Closures revised

The revised Ph. Eur. Monograph 3.2.9. on rubber closures will become official on July 1, 2018 (Supplement 9.5). Read more about Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders.



Missing Tests for Identity lead to FDA Warning Letter

A Canadian manufacturer of medicinal products received an FDA Warning Letter due to the fact that not all batches of manufactured drug products and the active materials used therein had been tested for compliance with the specifications before their release. Get information on the Cellex-C FDA Warning Letter.



Now online: Draft ICH Q12

The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website. Read more about ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.



USP <381> Elastomeric Closure for Injections

The USP General Chapters Packaging and Distribution Expert Committee recently posted the intent to revise General Chapter <381>. The Chapter currently includes a reference to <231> Heavy Metals, which will be omitted on January 1, 2018. Read more about the revision of Chapter <381> Elastomeric Closure for Injections.



USP Stimuli Article: Proceedings of the Analytical Lifecycle Workshop 2016

The USP published a stimuli article containing the Highlights of the US Pharmacopeia (USP) and ECA Academy Workshop on the Lifecycle Approach of Analytical Procedures.



Draft DIN EN ISO Injection Vials made of Tubular Glass

The DIN EN ISO committee published a draft for DIN EN ISO 8362-1 Injection vials made of glass tubing for comment.



Revision of the USP chapter on Raman

Raman is a technique often used for incoming API and excipients inspection besides IR and NIR. New suggestions for updating the chapter were published in the USP's Pharmacopeial Forum. Find more information on USP chapter <858> Raman Spectroscopy.



EU Inspection Complaints due to inadequate Handling of OOS Results

The recall of already released batches, the withdrawal of the currently valid GMP certificate and the import ban for Europe are amongst the most notable consequences of an EU GMP inspection in India. The main focus was on faulty OOS management. Read this news for more information about the "Statement of Non-Compliance with GMP" for Dr. Reddy's Laboratories Ltd.



Rationale to the revision of USP Chapter <381> Elastomeric Closures for Injections

The USP has recently undertaken an in-depth review of chapter <381> which has resulted in significant revisions especially to the heavy metals and functionality tests. In a stimuli article the USP now provides the rationale for the proposed changes to USP general chapter Elastomeric Closures for Injections <381>.



"Analytical Procedure Lifecycle Management" Guidance for all participants of the APLM Conference

ECA's Analytical Quality Control Group (AQCG) is currently drafting a comprehensive new Guideline on 'Analytical Procedure Lifecyle Management' (APLM) to support the lifecycle approach for analytical procedures. Find out more about this new and important APLM Guidance document and the related APLM Conference.


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