GMP News - Aseptic / Microbiology


Annex 1: the real Novelty

The revised Annex 1 to the EU-GMPs will bring a lot of new requirements. One of the major developments is the need for the implementation of a comprehensive Quality Risk Management System.



New Ph. Eur. Developments in the Visual Inspection of Injectables

Ph. Eur. chapter 2.9.20 on the visual control of parenterals is currently being revised. There are no major changes expected. What is much more interesting is the announcement of a new advising chapter. Read more about the new chapter 5.17.2 on visual inspection.



New USP Chapter <922> Water Activity

The United States Pharmacopeia, USP, posted the announcement of the elaboration of a new general chapter <922> on Water Activity.



How a 483 turned into a Warning Letter for Celltrion in South Korea

The South Korean company Celltrion had received a so-called 483 FDA report as a result of inspections performed in May and June 2017. Deficiencies were mainly observed in the aseptic area. Due to the - in their opinion - insufficient answer to the 483 report, the FDA has now issued a Warning Letter.



Guidance on Deviation Handling of microbiological Environmental Monitoring Excursions in non-sterile Pharmaceutical Manufacturing

The ECA Pharmaceutical Microbiology Working Group completed the first chapter of their guidance on handling of microbiological deviations to support members in dealing with OOS and OOL results.



New Annex 1: Consequences for the QP

The new  draft of Annex 1 (Manufacture of Sterile Medicinal Products) will be much more extensive and contain some new rules and additions. There are also some things in the Annex 1 draft QPs need to consider.



Revision of Annex 1 "Manufacture of Sterile Medicinal Products" published for Comments

The European Commission has published their long-awaited revision draft of Annex 1 "Manufacture of Sterile Medicinal Products" of the EU GMP Guideline.



Media Fill issues cause Non-Compliance Reports for Spanish Manufacturers

During two inspections, the Spanish supervisory authority found major deficiencies from two Spanish manufacturers of sterile medicinal products. Learn more about the Non-Compliance-Reports.



Become an active part of the Conference "Particles in Parenterals"

The ECA Foundation's Visual Inspection Interest Group has been conducting the annual conference "Particles in Parenterals" for several years now. For the planning of the 2018 event you can become involved as an active part.



Insufficient Media Fills in FDA Warning Letter

Insufficiently planned and performed media fills were at the centre of an FDA Warning Letter. Read more about the criticised deficiencies from a Warning Letter to the Korean manufacturer Firson Co., Ltd.



FDA Form 483 due to Particle Findings in a Product

The company Celltrion in South Korea received a so-called Form 483 report as a result of an inspection of the facility in May and June 2017. Amongst other things, it criticised particle findings in released products, insufficient environmental monitoring and deficiencies in aseptic activities. Read more about the deficiencies found during the inspection.



Frequently asked: What does the Exposure Time of Disinfectants mean?

The question after the meaning and the handling of indicated exposure times of disinfectants is asked again and again.



FDA Warning Letter relating to the Use of an alternative microbiological Method

The FDA issued a Warning Letter objecting to inadequate microbiological testing and product contamination with Burkholderia Cepacia and other microorganisms and following adverse events. Find out more abou the FDA Warning Letter.



EMA Non-Compliance Report for Brazilian Manufacturer of sterile Products

During an inspection, the Italian regulatory agency found major deficiencies at the site of a Brazilian manufacturer of antibiotics. Read more about the EMA's Non-Compliance Report.



EMA publishes final Version of Q&A Paper on Production of "cold" WFI

After the change to the European Pharmacopoeia, it is possible to produce water for injection by other methods than distillation since April 1st 2017. The European Medicines Agency (EMA) published a Q&A draft document in 2016 as an additional guideline. These Questions & Answers on WFI have now been published in its final version.


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