Validation Master Plan

Environmental Control Master Validation Plan

An environmental control plan (ECP) plan can be developed in newly established companies prior to the transfer of the first product from development into production and Quality Control (QC). The plan, in this case, will serve as a “roadmap” for the identification and creation of the procedures, training, records, and supporting activities required to establish the ECP.

For existing companies, an ECP plan can be developed as an evaluation tool. The plan, in this case, can serve as an assessment for the adequacy of the procedures, training, and recordkeeping to support a balanced ECP. A balanced program requires facility and utility design, raw material selection, cleaning procedures, personnel/material flows, preservative systems, and environmental monitoring procedures that result in a minimal risk to product and patient safety that is consistent with product and regulatory requirements.

The objective of an ECP is to integrate the elements of the ECP into a balanced environment that will ensure the performance and reliability of the product consistent with regulatory requirements.

Download the accompanying paper, "Environmental Control Programs: What They Are and What They Should Be," published in The Journal of GXP Compliance.

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