GMP News - Pharmaceutical Technology


Particles in Parenteralia - FDA’s perspective

An FDA representative talked about the US-American authority’s perspective as concerns particulate matter in sterile drug products at the ECA conference "Particles in Parenterals" in May this year. Read more here.



New FDA Guidance for the Prevention of Cross Contamination of Beta-Lactam Antibiotics

In April the US authority FDA issued the finalised Guidance paper with recommendations on the separation of the manufacture of not-penicillin Beta-Lactam antibiotics. Read more.



FDA Warning Letter on Water Purification

An FDA Warning Letter dated February 2013 describes deviations identified during the inspection of an US-American company. Apart from the failure to adequately investigate and document OOS test results, failures in the stability program and deviations in the water purification are the main content. Read more.



New WHO Guideline on the Establishing of Hold Times of Intermediate and Bulk Products

In February, the World Health Organisation (WHO) published a draft for a new guideline that gives assistance in designing studies for establishing hold times of intermediate and bulk products prior to packaging in the final containers. Read more.



AQL testing in the visual inspection of parenterals (FAQs)

An increasingly asked question is whether an AQL inspection is required as part of the visual inspection of parenterals. Get more details here.



FAQs concerning the visual inspection of Parenterals

The issue manual versus fully automatic inspection with regard to a 100% visual inspection of parenterals is a frequently discussed GMP issue. Please find a list of Q&As on this subject in our GMP News Read more.



Discussion of elemental Impurities in pharmaceutical Water

The question arose if pharmaceutical water need to comply to the requirements of USP <232> with regard to elemental impurities, especially if water is the main component of a medicinal product. These requirements are much more tighten than the traditional test on heavy metals (pb) which has been replaced by the conductivity measurement. Read more.



Cross-contamination: Topic of the Revisions of Chapters 3 and 5 EU GMP Guideline

The revisions of the chapters 3 and 5 of the EU GMP Guideline published in January concern exclusively the topic cross-contamination and the measures aimed at minimising the risk of cross-contamination. Read more.



New EMA Guideline on Dedicated Facilities and Exposure Limits for Cleaning Validation

The European Medicines Agency (EMA) published the long-awaited draft of the Guideline on setting health based exposure limits in January 2013. This has an impact on the limits to be observed in the cleaning validation and on the requirements on shared/multipurpose or dedicated facilities. Read more.



EMA publishes Concept Paper on Dedicated / Shared Facilities

In October, the European Medicines Agency published a new Concept Paper which has been developed by the Safety Working Group together with the GMP/GDP Inspectors Working Group. The document focuses on the establishment of an harmonised risk identification with toxicological data. Read more.



WHO issues revised version of HVAC Guide

In July the World Health Organisation (WHO) issued a revision of its HVAC Guide. Read on here.



Results of the Survey "Implementation of the new Annex 1 requirements for Capping"

Concept Heidelberg started a European survey about the implementation of the requirements to Annex 1 for Vial Capping in 2010 . You can find the first results here.



ISPE publishes new Baseline on the Subject of Risk Management

Dated September 2010, the International Society of Pharmaceutical Engineering (ISPE) has published a new baseline entitled "Risk-Based Manufacture of Pharmaceutical Products" (Risk-MaPP). The title implies a broader field of application than actually described in the baseline - read on for more details...



EDQM initiates survey about the production of Water for Injection (WFI)

Currently, the European Pharmacopoeia only allows distillation for the production of Water for Injection (WFI). The EDQM has initiated a survey through industry associations to gather suitable information and data. You will find more here.



EMA Update on Dedicated Facilities

Within the framework of the discussion on the topic of dedicated facilities, changes to the EC GMP Guide are imminent. Now the EMA has published an update on the current state of affairs. Read more.


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