Annex 1 of GMP applies to industries producing sterile products. Initially published in 1971, it underwent a major modification in 2022, allowing its reorganization and clarifying its initial content. This new version, applicable and auditable from August 2023, also sees the appearance of a new concept: the CCS.


What is a CCS

A CCS (Contamination Control Strategy) is a document describing the strategy adopted by the manufacturer to minimize the risks of contamination of the finished product by microorganisms, particles, and endotoxins and the means used to control this contamination.

The implementation of CCS is based on understanding the production process and the product. It must cover the entire product life cycle and constantly improve and update (following QRM, PQR, NC, CCR, and audits).

The controls set up to minimize all types of contaminations are defined according to the material, equipment, facilities, operating conditions, IPC (Process Control), finished product specifications, and the methods and frequency of environmental controls carried out.

Contamination strategies include but are not limited to critical data and processes, equipment sterilization, people and personal protective equipment controls, materials controls, room classifications, and barrier technologies.


Challenges of the implementation of the CCS

The two main concepts highlighted in this new version of Annex 1 are “Contamination Control Strategy” and “Quality Risk Management”. These notions require manufacturers to demonstrate control of the risk of contamination during the entire manufacturing process.

This implementation remains particularly challenging as it requires time, resources, and expertise. An external workforce might be temporarily needed to deal with this topic to ensure the right implementation.

As a global company, ProductLife Group can support you with our quality and regulatory expertise for optimizing your implementation and reviewing risk analyses and the CCS model. We are adept at providing due diligence on existing contamination control documentation or can create a unique strategy for your products. Trust PLG for the quality and safety of your products.

Contact us

Register to our news and events

Go to our Events to register
Go to our News to get insights

Annex 1: Implementation of a CCS