Warning Letter to Indian Manufacturer: Dead Legs and Missing Validation
Due to the deficiencies identified during an inspection that the FDA had already conducted in February 2020, an Indian pharmaceutical manufacturer has now received a Warning Letter. The main reasons for this were deficiencies in equipment design, validation and incoming goods inspection. Read more here.
Warning Letter for US Repacker: Deficienceis in Cleaning and Stabilities
A repacker in the US has recently received a Warning Letter from the FDA. The described deficiencies are repackaging of products in non-equivalent primary packaging, the lack of cleaning validation and the establishment of a suitable quality unit.
Deficiencies in Media Fills and Smoke Studies: Warning Letter
A US-American pharmaceutical manufacturer was inspected by the FDA in February 2020. Due to serious deficiencies in the media fills and smoke studies in the aseptic area, the manufacturer has now received a Warning Letter.
British Authority Criticizes Insufficient Prevention of Cross Contamination
The British health authority MHRA has recently published a statement in its blog, which reports about insufficient measures to avoid cross contamination in multipurpose facilities. This has been noticed in recent inspections.
Survey Results on the Use of Electronic Documentation in Equipment Qualification
Since at least the end of the 80s, equipment qualification has been an official expected standard. In the meantime, electronic documentation systems have been widely used. Nevertheless, pharmaceutical companies often still work with paper, especially in the field of equipment qualification. Would it not be possible to use more qualification documents electronically? This is something we wanted to find out from you. 14 questions were asked to give an overview of this topic.
Hormones and Homeopathics on the same Equipment: Warning Letter
A manufacturer of homeopathic drugs and hormone preparations in the USA has received a Warning Letter from the FDA due to several GMP violations. Among other things, highly active drugs were produced on the same equipment as the other products.
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.
WHO Pharmaceutical Water Guideline: Revision goes into next Round
The WHO published the revised draft of its guideline "Good Manufacturing Practices: water for pharmaceutical use" already end of July. The first revised draft of the guideline was published in May 2020. The new, second version contains further changes.
New Edition of the VDI Standard on Hygiene Training for HVAC Systems
The VDI (Verein Deutscher Ingenieure, Association of German Engineers) has re-issued Part 2 of VDI Standard 6022 on the requirements for hygiene training of persons entrusted with HVAC systems. The latest valid version of this document dates from 1999.
Current Developments in Piping Technology: Bending and Passivation
The costs for construction - but also for reconstructions - vary considerably. Tenders for this also often vary considerably. Currently, there are two interesting developments in this area: the increased use of bending machines and the renunciation of chemical passivation. Read more here.
EMA finalises Guideline on the Use of Pharmaceutical Water
The European Medicines Agency (EMA) has published the final version of its guideline on the use of the different pharmaceutical water qualities. The revision had become necessary due to the possibility to produce WFI using methods other than distillation. Read more here.
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's Pharmaceutical Water Guideline to be revised
The WHO guideline "Good Manufacturing Practices: water for pharmaceutical use" is currently being revised. The WHO issued a draft for public comment in May 2020.
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.