What is the “Contamination Control Strategy (CCS)” Required by the Revised EU GMP and PIC/S GMP Annex 1?
In 2022, both EU GMP Annex 1 (August 25, 2022) and PIC/S GMP Annex 1 (September 9, 2022) were revised, resulting in significant changes from the previous Annex 1. Among the key points of the revisions, the “Contamination Control Strategy (CCS)” is required in various sections, making the formulation of CCS a critical topic in the revised Annex 1.
What is CCS? (From the PIC/S GMP Annex 1 Glossary)
Annex1 Glossary
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEXES (PE 009-17)
Annex1 Glossary
Contamination Control Strategy (CCS) – A planned set of controls for microorganisms, endotoxin/pyrogen and particles, 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.
Elements to Consider in the “Contamination Control Strategy (CCS)”
The development of CCS requires detailed technical and process knowledge. Potential sources of contamination include microbial contamination, cell debris (such as pyrogens and endotoxins), and particulate matter (such as glass, other visible, and sub-visible particles). The revised Annex 1 requires that the elements to be considered in CCS include at least the following (Annex 1 2.5):
- 1.Plant and process design (including related documentation)
- 2.Facilities and equipment
- 3.Personnel
- 4.Utilities
- 5.Raw material management (including in-process controls)
- 6.Product containers and closures
- 7.Vendor approval (including suppliers of key components, providers of sterilization -services for parts and single-use systems, and other critical service providers)
- 8.Outsourced activities (such as contract sterilization services) and the management of the availability/communication of critical information between parties
- 9.Process risk assessment
- 10.Process validation
- 11.Validation of sterilization processes
- 12.Preventive maintenance (maintaining equipment, utilities, and facilities to a -standard that ensures no additional contamination risk, both planned and unplanned)
- 13.Cleaning and decontamination (disinfection)
- 14.Monitoring systems (including the assessment of the possibility of introducing scientifically sound alternative methods for the detection of environmental contamination)
- 15.Preventive mechanisms (such as trend analysis, detailed investigations, root cause identification, corrective and preventive actions (CAPA), and the need for comprehensive investigative tools)
- 16.Continuous improvement based on information obtained from the above.
Contamination Control Strategy (CCS) Consulting Services by CM Plus
CM Plus offers the following support services tailored to the needs of customers considering CCS formulation.
STEP 01. Understanding the Key Points of CCS FormulationSeminar on the Revised Annex 1/CCS Formulation
We summarize the changes and key points in the revised ANNEX 1, focusing on the points of the revisions. We provide guidance on interpreting CCS-related descriptions and offer examples of CCS document structures to help visualize the actual creation of CCS documents.
STEP 02. Reviewing the Current CCSCCS Gap Analysis and Proposal of Review Methods for Individual CCS
We conduct a gap analysis and review the current contamination control measures, identifying issues and proposing improvement support.
STEP 03. Preparing Concrete DocumentsCCS Document Preparation Support
We provide standard templates for CCS documents in line with the revised Annex 1 and, combined with the analysis in Step 2, we support the preparation of documents tailored to the client’s needs.
Feel Free to Contact CM Plus
CM Plus has consultants from various fields who can customize services to meet your needs. Feel free to contact us.
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Useful Information
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“Contamination Control Strategy (CCS)” Required by the Revised Annex 1
From the article:
“The EU ‘GMP Guidance Annex 1’ (the same content also applies to PIC/S Annex 1) has been revised, requiring the formulation of a comprehensive strategy for contamination control called ‘Contamination Control Strategy (CCS).’ ….”
Understand the purpose from the background of its revision.
Including a translation of the ECA’s Contamination Control Strategy formulation guideline: “How to Develop and Document Contamination Control Strategy.”
