The European Commission completed the amendment of EU GMP Annex 1, Manufacture of Sterile Medicinal Products for Human and Veterinary Use, in August 2022. This has increased the annex's length to over 50 pages and includes new expectations as well as additional details on many of the existing requirements. With an implementation deadline of 25 August 2023, for most issues, manufacturers need to be gearing up now. Whilst there are many resources giving more details on Annex 1 (see More Resources at the bottom of this page), in this rapidmicrobiology special focus, we showcase solutions that are going to help your facility achieve Annex 1 compliance.

One of the cornerstones of the revision is the need for a Contamination Control Strategy (CCS). Part of a CCS is environmental monitoring, discover from SherpaPharma the most critical aspects of the Annex relating to Environmental Monitoring.

For Quality Risk Management (QRM), Charles River Laboratories provide versatile ATP-based rapid microbial testing that is suitable for a wide range of materials including cell-based samples. Identifying any contamination as quickly and as confidently as possible can be done with the Accugenix® genotypic method, based on robust libraries delivering identification and strain typing. Charles River offers a highly reliable 15-minute LAL test for endotoxin testing of critical utility water systems such as Purified Water (PW) and Water For Injection (WFI) ensuring they are free from contamination, such as biofilm.

Available to download is bioMerieux's GMP Annex 1 Digest which covers: Annex 1 main documents, CCS details, principles of QRM, use of rapid alternative and automated microbiological methods,  identification strategy for environmental contaminants, plus new ways of bacterial endotoxin detection.

Cherwell's investigations indicate organisations need to ensure that their choice of prepared media plates, when used in combination with their chosen air sampler, are giving accurate results. Available to download is their updated Guide to Environmental Monitoring Processes and Validation which includes specific detail on the new version of EU GMP Annex 1.

For high-performance weighing and digital workflow management, Sartorius' Cubis^® II analytical balance offers a Pharma Software Application Package that supports compliance with FDA 21 CFR Part 11 and EU GMP Annex 11, USP Chapter 41.

Designing an Effective Quality Control Process for Annex 1 Compliance

With the issuance of the revised version of EU GMP Annex 1, we’ve outlined the key elements and applicable solutions to help ensure your final product is protected from contamination and safe for patients.
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Guidelines for the Manufacturing of Sterile Medicinal Products

Manufacturing of sterile medicinal products is subject to special requirements in order to minimize risks of microbial, particulate and endotoxin or pyrogen contamination. Learn how to manage risks to medicinal quality and safety.
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Weighing Solutions for Medical Devices Applications

Precision weighing balances for drug eluting stents for accurate, reliable results and increased productivity
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Microbiologics Custom Environmental Isolate Controls

Microbiologics simplifies environmental isolate and objectionable organism challenge testing by manufacturing your environmental isolates or target objectionable organisms into test-ready controls quantitated for your specific testing needs.
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Does Plate Choice Change Sampling Accuracy?

Read our report on our investigations into whether the choice of prepared media used within SAS air samplers can affect the sampling results achieved enough to impact whether your EM program is Annex 1 compliant.
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Microbial Monitoring Solutions for Sterile Medicinal Product Manufacturing Environments

With state of the art manufacturing facilities, HiMedia have an extensive portfolio of Microbiological culture media plates, microbial air samplers, and swabs, providing end-to-end solutions for monitoring of the environment.
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Stericheck^® - Universal Operator Broth Transfer Validation Pack

The Universal Operator Broth Transfer Validation Pack is designed specifically as an easy to use all-in-one kit for process simulation kit to test aseptic operations in hospitals, pharmaceutical and other cleanroom environments.
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Red One™: Rapid Sterility Results in 4 days

Redberry offers the fastest Rapid Sterility Solution based on compendial sample preparation - incubation parameters and double canister device - in accordance with Ph. Eur. 2.6.1. This method is under validation and allows identification post-analysis.
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Is Your Environmental Monitoring In Line With The New Annex 1?

The 2022 version of the GMP Annex 1 defines some stringent requirements in relation to Environmental Monitoring. August 2023 is the deadline to comply. Are you ready? In summary, the following are the most critical aspects of the Annex related to Environmental Monitoring:  
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Cherwell Publishes New Guide to EM Best Practice in Compliance With Revised Annex 1

Download Cherwell's Environmental Monitoring eBook for a detailed review of all changes included in the extensive EU GMP Annex 1 59-page 2022 revision of key regulations governing the manufacture of sterile medicinal products in the UK and Europe.
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Other resources:

Structuring Your Contamination Control Strategy by Tim Sandle

ATMPs and Annex 1: Some Answers, but More Questions - PDA Letter

PDA Annex 1 Workshop Six Key Takeaways - PDA Letter

Download the VALSCOURCE roadmap for a step-by-step action plan 'Understand Annex 1: Know the Requirements'

PDA Announce New EU GMP Annex 1 Implementation Interest Group

PDA's interest group and workshop will help the pharmaceutical/biopharmaceutical industry implement new requirements in Annex 1
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