CCS Task Force issues new Guideline

Contamination Control Strategy (CCS) - A  New Guideline from ECA

The ECA is proud to announce that its Task Force on Contamination Control Strategy developed a new Guideline Document for Industry. It is the aim of this Guideline to support industry with the implementation of this important requirement. Moreover, ECA would like to invite representatives from regulatory authorities and inspectorates to discuss the proposals made in this Guideline document in order to support harmonisation.

The latest draft of the revision of EU GMP Annex 1 contains the following statement:

"Contamination Control Strategy (CCS) - A planned set of controls for microorganisms, pyrogens and particulates, derived from current product and process understanding that assures process performance and product quality. The controls can include parameters and attributes related to active substance, excipient and drug product materials and components, facility and equipment operating conditions, in- process controls, finished product specifications, and the associated methods and frequency of monitoring and control."

This is the first time that an overview strategy is required for the area of contamination control that links the various aspects of contamination control and associated measures, records the interactions and facilitates a corresponding analysis for gaps in the system. This can be used in existing companies to meaningfully record, coordinate and supplement existing measures or, in newly emerging facilities, to coordinate the implementation of the necessary contamination control measures across departments.

ECA´s Task Force prepared a Guideline document that supports the user in creating a CCS, building up the documentation (comparable to a Site Master File – SMF) and thereby fulfilling the requirements of EU GMP Annex 1.

The ECA Guide contains a 3-stage-approach to achieve "CCS-readiness."

  • Stage 1: Development (or review and refinement/improvement) of the CCS
  • State 2: Compilation of the CCS documents
  • Stage 3: Evaluation of the CCS

This document is intended to provide guidance for two possible cases:

1. For a new plant, new equipment, e.g., for:

  • Mapping of the manufacturing processes to identify possible sources of contamination.
  • Carrying out a risk assessment to evaluate the risk of contamination.
  • Establishing preventive measures and their controls in a holistic system (including the definition of responsibilities).
  • Assessing and managing the residual risk of contamination.

2. For an existing facility that has already carried out a risk assessment, e.g., for:

  • Evaluation of existing contamination control measures
  • Analysis and overview of possible gaps
  • Risk assessment and, if necessary, the addition of further measures and integration into the overall system (including determination of responsibilities)
  • Managing the residual risk of contamination

The ECA offers this Guideline document at no costs for all colleagues in pharmaceutical industry and authorities. This is in line with ECA´s overall strategy not to charge for Guideline documents.

To receive a copy of ECA´s Guideline "How to Develop and Document a Contamination Control Strategy" please use this contact form.

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