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Preparation Workshop Facility Validation for Pharmaceutical Production
Project Overview
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.
Sterile Products
Sterile powder injections
Lyophilized Products
Freeze-dried powder injections
Large Infusions
High-volume parenteral solutions
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:
Plant Surroundings
Environmental conditions around facility
Architectural Design
Structural and layout specifications
Process Design
Plant process plane design
Utility Systems
Water supply, drainage, and electrical
Safety Systems
Fire protection and safety measures
Verification Team Members & Responsibilities
| Name | Department | Position | Responsibilities |
|---|---|---|---|
| Vice President of Quality | Quality | Executive | Coordinate verification organization, approve verification plan and report, issue certificates |
| Production Manager | Production | Management | Review verification plan, coordinate equipment installation, participate in verification |
| Workshop Director | Operations | Management | Review verification plan, oversee verification work, verify reports |
| Workshop Technician | Operations | Technical | Draft verification plan, perform verification tasks, write reports |
| Equipment Supervisor | Maintenance | Supervisory | Perform measurements, oversee installation confirmation |
| QA Supervisor | Quality Assurance | Supervisory | Coordinate verification work, develop plan, review reports |
| Validation Engineer | Validation | Engineering | Sampling, plan submission, burial work, certificate issuance, daily management |
| Field Engineer | Engineering | Engineering | Perform sampling during verification process |
Document Drafting & Training
The verification team conducts corresponding training according to the verification time schedule to ensure all members understand their roles and responsibilities.
Training Program Includes:
- GMP regulations and compliance requirements
- Verification protocols and procedures
- Sampling methodologies and techniques
- Documentation standards and reporting
- Safety procedures in cleanroom environment
- Equipment operation and maintenance
Clean Plant Facility Revalidation Plan for Preparation Workshop
This document complies with GMP regulations and pharmaceutical quality standards
