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.
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.
Numerous GMP Deviations found at US Manufacturing Site
Due to the deficiencies discovered during an inspection performed in July 2018, the US FDA has now issued a Warning Letter to a US pharmaceutical manufacturer of homeopathic drug products. Microbiological impurities in the products and the water used to manufacture the medicinal products are an essential aspect of the complaint.
Is the Sanitization Temperature for Water Systems too high?
The most common method of preventing microbiological contamination in a water system is thermal sanitisation. There are systems in which the pharmaceutical water is stored hot and systems that are heated cyclically to an elevated, germicidal temperature. However, excessive temperatures not only increase costs, they can also damage the materials. Read more here.
Does Purified Water (PW) have to be tested for Endotoxins?
Within the framework of risk analysis, qualification and preparation of sampling plans for new purified water (PW) systems, the question arises as to whether PW should be tested for endotoxins. Read more here.
In February 2019, the WHO published a new Guideline for comment on the production of WFI using non-distillation methods. Read more about the draft entitled "Production of Water for Injection by Means other than Distillation".
WHO and IAEA - Draft Guideline on GMP for Radiopharmaceuticals
In January 2019, the World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) published a draft guideline dealing specifically with the GMP requirements for the manufacture of radiopharmaceuticals.