Overview of Clean Room Validation in Pharmaceutical Plants

Author:Jason Peng
Cleanroom Engineering Technology Manager of Deiiang Company.

Product R&D Manager of GDC Inc. Cleanroom Equipment Manufacturing Company.

Executive Director of Guangdong Cleanroom Industry Association of China.

Engaged in R&D of related products for 15 years, with rich relevant technical experience
2024-11-19 | Visits:

It is necessary to revalidate the comprehensive preparation workshop to prove that the plant facilities will not cause pollution to the production process, and that qualified products such as sterile powder injection, lyophilized powder injection and large infusion that meet the requirements can be produced in this clean plant.

Verification purpose

Check and confirm that the design, installation, clean decoration, water supply and drainage, electrical and safety fire protection of the clean plant change process of the preparation workshop meet the requirements of relevant laws and regulations and GMP, and the data and documents meet the management requirements of GMP. Prove that the plant facilities of the preparation workshop will not cause pollution to the production process, and qualified products such as sterile powder injection and large infusion can be produced in this plant.

Verification scope

This plan is applicable to the verification of clean plants and facilities in preparation workshops. This verification plan includes design confirmation, installation confirmation, operation confirmation and performance confirmation of plant facilities. The plant facilities are verified from the aspects of the surrounding environment of the plant facilities, architectural design, plant process plane design, water supply and drainage, electrical, safety fire protection, clean decoration, etc.

Verification team members and responsibilities

name	department	Position	Responsibilities in this verification work.
		Vice President of Quality	Coordinate the verification organization and related technical work, approve the verification plan and report, and issue verification certificates.
		Production Manager	Participate in the review of verification plan, be responsible for the organization and coordination of equipment installation and commissioning, and participate in all verification work.
		Workshop Director	Participate in the review of verification plan, be responsible for related verification work and verification report verification.
		Workshop Technician	Participate in the drafting of verification plan, be responsible for related verification work and write related verification report.
		Equipment Supervisor	Responsible for measurement work during verification process, installation confirmation during verification process.
		QA Supervisor	Coordinate and organize verification work, formulate verification plan, and be responsible for the review of verification plan and report.
		Validation Engineer	Sampling during verification process, submission and signing of verification plan and report, burial work, issuance of verification certificate and daily management of verification.
		Field Engineer	Related sampling work during verification process.