GMP News - Aseptic / Microbiology


New USP Chapters regarding Testing for Subvisible Particles

The USP has published the revised chapter on testing for non-visible particles <1788> as well as new monographs on the individual test methods light obscuration, membrane microscopy and flow imaging as drafts.



General requirements for Plastics in Pharmaceutical Engineering

The main material used in plant engineering is stainless steel. The variant 316L is regarded as standard; material incompatibilities of steel with the product play almost no role. This is different for plastics. Beside the leach-out, ageing and surface finishing, other quality features are often specified. Now, what are the general requirements for plastics in pharmaceutical plant engineering?



Japanese Pharmacopoeia - Draft Chapter of alternative Endotoxin Testing

The Japanese Pharnacopoe has published a new chapter draft of "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay" for comment.



FDA Guide for Non-clinical Studies of Oncological Therapeutic Radiopharmaceuticals

The FDA has published a final guideline for non-clinical studies of "Oncology Therapeutic Radiopharmaceuticals" to close the gaps in the existing FDA and ICH Guidelines.



GMP for Radiopharmaceuticals - WHO/IAEA Guideline open for comments

In July, the WHO and the IAEA published a draft guideline for the specific GMP requirements for the manufacture and control of radiopharmaceuticals, which can be commented until 20 September.



Media Fill and Aseptic Behaviour in Focus of FDA Warning Letter

Significant deficiencies in the pharmaceutical quality management system led to a Warning Letter to the American company Akorn. What deviations in media fill and aseptic behavior were detected in the inspected company?



Warning Letter for Indian Sterile Manufacturer

Indian sterile manufacturer Emcure Pharmaceuticals has once more received a warning letter from the FDA with concerns to the root cause analysis of deviations in sterility testing.



Warning Letter due to Deficiencies in the Purified Water System

In June, a US-American pharmaceutical manufacturer received a Warning Letter from the FDA due to deficiencies in the Purified Water System which concern - among other things - the design of the water system, monitoring, sampling and handling of CAPAs.



What is considered GMP-compliant equipment design?

It's a frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP-compliant equipment design.



WHO publishes Draft Guideline on Production of WFI using Non-Distillation Methods

The WHO has reacted to the changes in the European Pharmacopoeia by issuing a draft guideline on the production of WFI (Water for Injection). The commentary phase is open to the public, comments can be submitted until 20 September 2019.



Warning Letter: Serious Defects in Zoning, Cleaning and Disinfection and Monitoring

The US FDA issued a Warning Letter to a US company with aseptic production due to serious deficiencies in room zoning, personnel, environment monitoring and disinfection.



Do liquid, sterile medicinal products have to be particle-free?

According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.



Warning Letter for US Pharmaceutical Manufacturer: Container/Closure Issues and Other Deficiencies

The US FDA has recently published a Warning Letter describing the deficiencies observed during an inspection performed in September 2018 at a US pharmaceutical manufacturer. One serious deficiency concerns leaking product containers. Furthermore, defects in the stability programme, in the CAPA system and in data integrity have also been reported.



Warning Letter for Sterile Manufacturer of Ophthalmic Drugs in the US

In May, the FDA published a Warning Letter to a US American sterile manufacturer of ophthalmic drugs which highlights serious deficiencies, especially in sterile production and in the general understanding of GMP. Read more here.



Warning Letter on Data Integrity Issues in the Microbiological Laboratory

Among other things, insufficient or missing reports of test results in a microbiological laboratory resulted in a Warning Letter addressed to the company concerned. Read more about the Warning Letter to Hospira Healthcare India Pvt.


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