GMP News - Aseptic / Microbiology


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.



EMA Guide on Sterilisation for Medicinal Products, API Excipients and Primary Packaging published

At the beginning of March, the EMA published a guideline for the sterilization of drugs, active ingredients, excipients and also primary packaging.



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.



Test for bacterials Endotoxin - New EP Chapter on recombinant Factor C open for public Comments

The European Commission and the EDQM have published a new chapter of the European Pharmacopoeia for testing bacterial endotoxins with recombinant factor C (rFC) for public comment.



New WHO Guideline on "Cold Production of WFI"

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.



Warning Letter for Korean Manufacturer due to Poor Sterile Practices

As a result of repeated deviations in the area of aseptic manufacturing, a Korean manufacturer has received a Warning Letter from the FDA.



Expectations of the British MHRA on Decontamination with Hydrogen Peroxide

Decontamination by means of vapour hydrogen peroxide is a well established procedure for isolators. Now, the question is what the expectations of the British Authority MHRA are with regard to sterilisation of direct and indirect contact parts in isolators. Andrew Hopkins - among others chairperson of the working group for the revision of Annex 1 - published his opinion on that.



European Pharmacopoeia: New Chapter on Visual Inspection for Visible Particles

The European Pharmacopoeia has published a new chapter on testing of parenterals for visible, particulate matter in Pharmeuropa 30.4.



Serious GMP Deficiencies at Italian Sterile Manufacturer

On the basis of a GMP inspection performed at an Italian sterile manufacturer, the Italian authority (AIFA) recommended the recall of batches and issued a GMP non-compliance report. Read more about the GMP deficiencies observed.



Microbiological Environmental Monitoring in the Focus of an FDA Warning Letter

The topic microbiological environmental monitoring was one of the main focuses of an FDA Warning Letter. Read more about the deviations listed in the FDA Warning Letter issued to the Taiwanese company Taiwan Biotech.



Annex 1: the real Novelty

The revised Annex 1 to the EU-GMPs will bring a lot of new requirements. One of the major developments is the need for the implementation of a comprehensive Quality Risk Management System.



New Ph. Eur. Developments in the Visual Inspection of Injectables

Ph. Eur. chapter 2.9.20 on the visual control of parenterals is currently being revised. There are no major changes expected. What is much more interesting is the announcement of a new advising chapter. Read more about the new chapter 5.17.2 on visual inspection.



New USP Chapter <922> Water Activity

The United States Pharmacopeia, USP, posted the announcement of the elaboration of a new general chapter <922> on Water Activity.


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