GMP News - Aseptic / Microbiology

18.02.20

Second Chapter of ECA's Microbiological OOS/OOL Guideline announced for May

The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.

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17.02.20

Harmonisation of the pharmacopoeial Texts for use in the ICH Regions on Micro Enumeration finalized

Reaching step 5 of the harmonisation process, the European Medicines Agency (EMA) adopted the ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration.

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17.02.20

Specified Microorganisms - Harmonisation of the pharmacopoeial Chapters completed

The International Council for Harmonistion (ICH) finalized their recommendation relating to the use of the pharmacopoeial texts on tests for specified microorganisms.

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17.02.20

EDQM publishes Press Release on microbiological Control Symposium

Two weeks after their microbiology symposium in Strasbourg, the European Directory for the Quality of Medicines and HealthCare (EDQM) summarized the event in their press release entitled "Microbiological control symposium: consensus on readiness of new methods emerges".

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11.02.20

ICH Q4B - Harmonisation relating to the Sterility Test - General Chapters completed

The International Council for Harmonisation ICH Q4B - Harmonisation of pharmacopoeial chapters on Sterility Test with step 5 has now been finalized.

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11.02.20

FDA Final Rule for Antiseptic Soaps

The FDA issued a Q&A document correlated to the final rule on Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.

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11.02.20

FDA - Bacteriological Analytical Manual, Microbiological Methods for Cosmetics

In July the FDA published the revised version of BAM: Bacteriological Analytical Manual Chapter 23 Microbiological Methods for Cosmetics.

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05.02.20

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.

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06.11.19

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?

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16.10.19

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.

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02.10.19

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.

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18.09.19

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.

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11.09.19

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?

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28.08.19

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.

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21.08.19

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.

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