Microbial Contamination Monitors

Contamination Control Strategies for Innovation and Regulatory Compliance

A Contamination Control Strategy (CCS) outlines a method to identify and analyze risk, review the mitigating opportunities and innovations, and ultimately define corrective and preventive action plans. Implementation of a CCS attempts to address the varied causes of contamination and compromised sterility.

This paper addresses The 3 Steps of Developing a CCS: Assessment, Acceptance, and Remediation.

  1. Assessment: Outline the CCS
  2.  Acceptance: Compilation of CCS Documentation
  3. Remediation: CCS Evaluation

Execution of a robust Contamination Control Strategy needs the support of subject matter experts in Manufacturing, Regulatory, Quality Control, Quality Assurance, and supporting departments. Contamination Control Strategy

Development of a CCS

The proposed elements to be considered for the CCS are listed in Annex 1:

“2.5 The development of the CCS requires detailed technical and process knowledge. Potential sources of contamination are attributable to microbial and cellular debris (e.g. pyrogen, endotoxin) as well as particulate (e.g. glass and other visible and sub-visible particles).

Elements to be considered within a CCS should include (but are not limited to):

i. Design of both the plant and processes including the associated documentation.
ii. Premises and equipment.
iii. Personnel.
iv. Utilities.
v. Raw material controls – including in-process controls.
vi. Product containers and closures.
vii. Vendor ….

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