GMP News - Aseptic / Microbiology

20.05.20

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.

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06.05.20

European Commission extends Deadline for Comments on the Revision of Annex 1 for the Manufacture of Sterile Medicinal Products in Eudralex Volume 4

Due to the effects of the corona pandemic, the European Commission is extending the comment period for the revision of Annex 1 of the GMP Guide.

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26.03.20

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.

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04.03.20

Annex 1: Consequences for the QP

The revised draft of Annex 1 (Manufacture of Sterile Products) was published. There are also some things to consider for QPs.

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26.02.20

GMP for Sterile Packaging Components

Will the revised Annex 1 provide guidance for the application of GMP to sterile primary packaging materials?

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26.02.20

Draft Annex 1: New Requirements for Lyophilization?

Will the revised Annex 1 introduce new GMP requirements for lyophilized products?

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20.02.20

Annex 1: European Commission Publishes Revised Document

On 20 February, the European Commission published the long-awaited revision of Annex 1 Sterile Manufacturing of the EU GMP Guideline. The document is now entering a timely limited commentary phase.

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18.02.20

Second Revision of FDA Guidance Microbiology Data for Systemic Antibacterial Drugs

FDA published the second revision of their Guidance for Industry "Microbiology Data for Systemic Antibacterial Drugs -Development, Analysis, and Presentation" to define the requirements on a overall microbiology development program for such products.

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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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