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.
Evidenced Cross-Contamination at Indian Manufacturer results in Warning Letter
The FDA has recently issued a Warning Letter to a large Indian pharmaceutical manufacturer following an inspection that revealed poor cleaning and later detected cross-contamination in manufactured tablets. Further GMP violations were detected like leaking HEPA filters and inadequate smoke studies in the sterile area.
A Chinese manufacturer has received a Warning Letter from the US-American FDA due to inadequate equipment design, deficiencies in monitoring and not performed laboratory tests as well as deficiencies in the Batch Record Review.
Warning Letter: Lack of Repairs at US-American Manufacturer
A US-American pharmaceutical manufacturer of OTC solutions and suppositories has received a Warning Letter from the US-American FDA due to non-executed repairs and deficiencies in cleaning and laboratory testing.
Foreign Particles in Oral Dosage Forms can also Cause Warning Letter
A US-American medical manufacturer has received a Warning Letter from the FDA due to foreign particles in a solution for oral application and especially regarding the handling of this incident. Besides, further deficiencies were observed during the inspection, such as errors in the evaluation of HPLC data and data integrity in the laboratory in general.
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.
Are Nickel-Plated Components Allowed in the GMP Area?
The nickel plating of surfaces is a good and high-quality method to protect components or surfaces from corrosion. At the same time, the question is repeatedly asked whether components treated in this way may be used in the GMP area. Read more here.
Deficiencies in Maintenance, OOS and Data Integrity lead to Warning Letter
A pharmaceutical manufacturer in India received a Warning Letter from the US-American FDA in December due to deficiencies in the areas of maintenance/cleanliness, OOS and data integrity. Read more here.