GMP News - Aseptic / Microbiology


FDA Plans for new (GMP) Guidance in 2021 - CDER provides Information

What are the FDA's plans regarding new guidances for the calendar year 2021? An answer to this question is provided by the Center for Drug Evaluation and Research (CDER) in their list of planned and / or to be revised guidance documents. On five pages, comprising 18 individual categories, these documents are presented.



Warning Letter due to Inadequate Pressure Stage Concept and Particle Monitoring

Due to deficiencies in the ventilation system and particle monitoring in the sterile area, an Indian pharmaceutical manufacturer has recently received a Warning Letter from the U.S. FDA. In addition, the microbiology testing was also criticized.



Warning Letter regarding Deficiencies in Aseptic Production - Part 2: Media Fill

Deficiencies in aseptic production have led to a Warning Letter to the Japanese company Takeda Pharmaceutical Company Limited. Part 2 of the News deals with deficiencies in the media fill.  What sort of issues did lead to this Warning Letter?



Warning Letter about Deficits in Aseptic Manufacturing - Part 1: Cleanroom Behaviour and Materials in the Aseptic Area

Deficiencies in aseptic production have led to a Warning Letter for the Japanese company Takeda Pharmaceutical Company Limited. Part 1 of the News deals with inadequate cleanroom performance and inadequate controls of materials used in aseptic production.  What were the reasons for this Warning Letter?



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At the end of July, the FDA (CDER) published a draft guidance document for setting endotoxin limits during the development of drugs for oncology and biological products.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


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