gbc-007 process validation.doc (英文)(doc 31頁)

gbc-007 process validation.doc (英文)內容提要:
PURPOSE
This SOP provides a procedure for qualification and validation of production processes, equipments, utility systems, facilities and laboratory equipment.

SCOPE
Cleaning & Sanitization Validation, Test Method Validation, Computer System Validation and Water Treatment System Validation are critical systems to be validated at all sites. Specific validation requirements for these systems are described in the relevant SOPs and Corporate Quality Guidance documents listed under the reference section of this SOP.
This SOP applies to all drug, cosmetic, and device products and processes manufactured in Beauty Care Product Supply (PS) facilities including Joint Ventures/Licensees. This SOP may also be used at contract manufacturing operations.
Any deviation from this SOP requires sound technical justification and must be approved by the site QA manager.

RESPONSIBILITIES
For new products, line extensions, and formulation changes, Product Development (PD) or Technical Services (TS) has lead responsibility to assure process validation is conducted and completed. This includes ensuring that critical processing parameters and acceptable ranges are identified, and required documents are written, including the Performance Qualification (PQ) Protocol and the PQ Report.
Product Supply (PS) has responsibility to write and execute the Installation Qualification (IQ) and Operation Qualification (OQ) protocol. This includes responsibility to prepare the IQ/OQ Report. For existing packing processes, making processes, utilities, facilities, and laboratory equipment used in the manufacture of existing products and changes to these systems, the sites have lead responsibility to assure process validation is conducted and completed. This includes lead responsibility to write the required documents.
The site QA Manager will assure validation files exist and are kept current.
The Site QA Manger will ensure that a Validation Master plan is available at site.
The Site QA Manager, and Operations Manager or their designee will review and approve all IQ/OQ and PQ protocols and reports.
The PD or TS Section Head or designee will review and approve all PQ protocols and reports for new initiatives.

PROCEDURE
Prior to any validation work all the protocols must be approved.
All validation data must be referenced or attached with the final validation report.
All Validation protocols will need to be referenced with a protocol number identifying the specific validation, preferred options would be to abbreviate the plant name or include the site code e.g. C&S validations can be referenced as CS0491 xxxx or a making equipment validation as MKG0491XXXX where 0491 is the site ID.
All completed Validation documents must be appropriately filed for future reference.
Below format and sections describe the detailed requirements for conducting Installation Qualification, Operational Qualification and Performance Qualification

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