Expectations of the British MHRA on Decontamination with Hydrogen Peroxide
Decontamination by means of vapour hydrogen peroxide is a well established procedure for isolators. Now, the question is what the expectations of the British Authority MHRA are with regard to sterilisation of direct and indirect contact parts in isolators. Andrew Hopkins - among others chairperson of the working group for the revision of Annex 1 - published his opinion on that.
Serious GMP Deficiencies at Italian Sterile Manufacturer
On the basis of a GMP inspection performed at an Italian sterile manufacturer, the Italian authority (AIFA) recommended the recall of batches and issued a GMP non-compliance report. Read more about the GMP deficiencies observed.
Microbiological Environmental Monitoring in the Focus of an FDA Warning Letter
The topic microbiological environmental monitoring was one of the main focuses of an FDA Warning Letter. Read more about the deviations listed in the FDA Warning Letter issued to the Taiwanese company Taiwan Biotech.
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.
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.
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.
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.