GMP News - Aseptic / Microbiology


Microbiological Environmental Monitoring at the Focus of an FDA Warning Letter

Deficiencies in microbiological environmental monitoring have led to a Warning Letter for the Korean company Samchundang Pharm Co. What deficiencies were found at the inspected company and what measures were required to remedy them?



Questions & Answers: Semi-Automated Visual Inspection

The webinar on semi-automated visual inspection of parenteralia on June 16, 2020 met with great interest. In addition to many basic questions regarding visual inspection, specific questions about semi-automated inspection were asked and answered during the webinar. Here you can find a short selection.



FDA publishes Guidance for Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products

At the end of July, the FDA (CDER) published a draft guidance document for setting endotoxin limits during the development of drugs for oncology and biological products.



Non Compliance Report for Deficiencies in Contamination Control

In the course of an inspection by the responsible supervisory authorities, considerable deficiencies in GMP compliance were discovered at a Polish manufacturer of non-sterile dosage forms.



Warning Letter to Canadian Manufacturers of Injectable Homeopathic Products

The FDA issued a Warning Letter to a manufacturer of aseptic homeopathics in Canada after the deficiencies listed in a 483 letter sent last October were not satisfactorily addressed.



Serious Deficiencies at US Sterile Manufacturer

The FDA has recently published a Warning Letter following an inspection conducted at a US-American manufacturer of ophthalmic sterile preparations, which revealed numerous serious deficiencies. These include environmental monitoring, lab data integrity, gowning procedures, media fill and maintenance/cleaning of production equipment.



WHO Guideline on "Cold" Generation of WFI finalized

In the middle of 2019, the WHO published the draft of the guideline entitled "Production of water for injection by means other than distillation" for the production of WFI by non-distillative methods. This finalised guideline has now been published as Annex 3 in the WHO Technical Report Series (TRS) 1025.



European Commission extends Deadline for Comments on the Revision of Annex 1 for the Manufacture of Sterile Medicinal Products in Eudralex Volume 4

Due to the effects of the corona pandemic, the European Commission is extending the comment period for the revision of Annex 1 of the GMP Guide.



European Pharmacopoeia: New Chapter on Visual Inspection for Visible Particles Comes Into Force

The new chapter 5.17.2 in the European Pharmacopoeia "Recommendations on testing of particulate contamination: visible particles" was already published for comment in autumn 2018 (Pharmeuropa 30.4). The comments and feedback received have been considered by the Expert Group 12 of the EDQM, and the chapter is coming into force.



Annex 1: Consequences for the QP

The revised draft of Annex 1 (Manufacture of Sterile Products) was published. There are also some things to consider for QPs.



GMP for Sterile Packaging Components

Will the revised Annex 1 provide guidance for the application of GMP to sterile primary packaging materials?



Draft Annex 1: New Requirements for Lyophilization?

Will the revised Annex 1 introduce new GMP requirements for lyophilized products?



Annex 1: European Commission Publishes Revised Document

On 20 February, the European Commission published the long-awaited revision of Annex 1 Sterile Manufacturing of the EU GMP Guideline. The document is now entering a timely limited commentary phase.



Second Revision of FDA Guidance Microbiology Data for Systemic Antibacterial Drugs

FDA published the second revision of their Guidance for Industry "Microbiology Data for Systemic Antibacterial Drugs -Development, Analysis, and Presentation" to define the requirements on a overall microbiology development program for such products.



Second Chapter of ECA's Microbiological OOS/OOL Guideline announced for May

The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.


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