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.
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.
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 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.
Non-Compliance Report for manufacturing of three Products at Biocon, India
The European Medicines Agency (EMA) and the French Agence nationale de sécurité du médicament et des produits des santé (ANSM) published a Non-Compliance Report after a Pre-Approval Inspection for three biosimilar products of Biocon Limited in Bangalore, India.
EMA non-compliance report on Indian manufacturer of sterile medicinal products
During a pre-approval inspection, the French supervisory agency found major deviations by an Indian manufacturer of sterile medicinal products. Find out more details about the EMA's non-compliance report here.
Guidance for Industry: Transmission Risk of West Nile Virus from Living Donors of Cells and Tissues
The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) updated the Guidance for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".
Recent FDA Warning Letter: Issues with Monitoring of microbiological Environments
Because of various severe GMP violations, the FDA issued a warning letter to an American manufacturer of wound disinfactants. The authority especially criticised deviations in monitoring of microbiological environments. Read the more about the Warning Letter to Aplicare from December 2016.
Warning Letter for Brazilian Manufacturer of Antibiotics
In the course of an FDA inspection at a Brazilian manufacturer of antibiotics, the inspector observed a few serious GMP violations which led ultimately to a Warning Letter. Read more about the FDA Warning Letter issued to the company Antibioticos Do Brasil Ltda.