GMP News - Aseptic / Microbiology


Revision of BAM Chapter 23: Microbiological Methods for Cosmetics

In May 2016, the FDA published some revisions in the text of the Bacteriological Analytical Manual, Chapter 23, "Microbiological Methods for Cosmetics".



Italian Manufacturer receives FDA Warning Letter for Hygiene Issues

On 20 May 2016, the U.S. American FDA published a Warning Letter for major hygiene issues in aseptic manufacturing. Find out more about the Warning Letter issued for the Italian manufacturer Corden Pharma Latina S.p.A.



New Extensive Warning Letter for Indian Manufacturer of Sterile Medicinal Products - Part 1

Again, the US American FDA has issued a Warning Letter to a manufacturer of sterile medicinal products. Comprehensive and serious violations of GMP principles were observed at the Indian manufacturer Emcure Pharmaceuticals Limited. Part 1 of the News deals with the topic insufficient aseptic practices. Read more about the most significant deviations in the Warning Letter.



Non-Compliance Reports for European Manufacturers of Sterile Medicinal Products

The Spanish and the Polish competent authorities have currently published two Non-Compliance Reports because of major deviations in the manufacturing of sterile medicinal products. Read more details about the new Non-Compliance reports.



Pharmeuropa - Comments concerning revised texts about Bacterial Endotoxins

In December the EDQM published the comments concerning revised texts of chapter 5.1.10. Guidelines for using the Test for Bacterial Endotoxins. Find out more about the scope and the added specific points in the Test for Bacterial Endotoxins Guideline.



FDA Guidance finalised: Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices

On 17 August, the FDA published the finalised Guidance for Industry and Food and Drug Administration Staff  "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices".



Revised Draft of Pharmeuropa Monograph 5.1.2. Biological Indicators

End of 2011 the Pharmeuropa 24.1 published a first draft of the monograph "5.1.2. Biological Indicators in the Preparation of Sterile Products" for discussion. Due to the abundance of comments, the draft was substantially revised and is now available in the Pharmeuropa 27.3 for comments again. Read more about the current Draft 5.1.2. Biological Indicators.



French Authority (ANSM) published statement of non-compliance related to mould contaminations

TxCell has shut down their pilot site in Besançon due to some deviations found during an inspection of the French authority. Amongst others, several mould contaminations were found. Read more details about the report of the authority.



European Pharmacopoeia - Chapter 2.6.27 Microbiological Examination of cell-based Preparations revised

The issue 27.3 of Pharmeuropa also comprises a revision of Chapter 2.6.27 "Microbial Examination of cell-based Preparations". It covers the cases where a test is not feasible according to chapter 2.6.1.



Contamination Control - Still an issue during inspections

Measures for contamination control are one of the basic requirements for the manufacturing of medicinal products. Still, contamination control issues got back in the TOP TEN List of 21 CFR 211 Citations. Read more about contamination control as an issue during inspections.



ECA Foundation and its Interest Group European QP Association comment on EU GMP Annex 1 Revision

In February 2015 the European Commission published a Concept Paper with the intent to revise the EU GMP Annex 1 on sterile manufacturing. The time frame provided by the EU Commission is very small.  End of March 2015 has been set as deadline for industry comments and in October 2015 a draft version of the revised EU GMP Annex 1 is planned to be published. Read more about the industry comments on the revision of Annex 1 to the EU GMP Guide.



Ph.Eur Chapter 2.6.8. Pyrogens Revision open for Comments

In Pharmeuropa issue 26.4, the EDQM published the draft of the revision of chapter 2.6.8. Pyrogens. It is open for comments until 31. December 2014. Read more.



Question and Answers to Endotoxin Masking and Low Endotoxin Recovery (LER)

Following ECA's webinar on Endotoxin Masking, the speaker summarized the questions related to masking and LER in a Q&A document. Read more here.



EDQM revises 5.1.10. Guidelines for using the Test for Bacterial Endotoxins

Recently, the EDQM published the revision of 5.1.10. "Guidelines for Using the Test for Bacterial Endotoxins" and added alternative methods like recombinant factorC. More details can be found here.



New FDA Interim Guidance for Human Drug Compounding Outsourcing Facilities

Compounding pharmacies in the US haven't been inspected by the FDA over the past years. For the first time, after a number of serious incidents which caused death, the FDA has tried to establish cGMP requirements for the manufacturers of outsourced drug compounding in an interim guidance for Industry. Read more details here.


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