Covering everything from the technology of particle counting, to the regulatory standards that apply to the pharmaceutical manufacturing industry, to the instrumentation and techniques needed to meet them. The Environmental Monitoring Handbook for Pharmaceutical Manufacturers helps readers understand the topic of EM more holistically and more extensively.
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
The primary importance of environmental monitoring for Advanced Therapeutic Medicinal Products (ATMP) facilities is to demonstrate the highest degree of control over
* The aseptic manufacturing environment
* The potential for cross contamination between batches / manipulations
To satisfy the assurances required by regulatory agencies, pharmaceutical products are manufactured in a controlled environment. Cleanrooms are an example of a controlled environment and are employed to reduce the contamination risk and variability of
