Management of Validation Protocols and Reports

Sample Document

Table of Content:

  1. Application
  2. Responsibility and Authority
  3. Safety and Process Specific Information
  4. Procedure
  5. Validation Project Numbers
  6. Registration in Validation Database
  7. Validation Item
  8. Project Item
  9. Preparation of Validation Documents
  10. Review and Approval of Validation Documents
  11. Amendments
  12. Appendix 1: Review / Approve Procedure for Validation Document

Sample Content

APPLICATION

To outline the procedure for the management of validation related projects and documentation.

RESPONSIBILITITY AND AUTHORITY

    • It is the responsibility of the Validation Department to assign a project number to the validation project and to ensure that the progress of the project is kept up to date in the Validation Database.
    • It is the responsibility of individual personnel (from outside the Validation Department) in charge of a project which requires validation to work in collaboration with the Validation Department on the generation of validation documents.
    • It is the responsibility of the Validation Department to provide guidance on the validation requirement of any given project.
    • In the case where the expertise of a vendor, contractor or consultant is engaged, it is the responsibility of the Validation Department to ensure that all validation documents are prepared according to GMP site’s standards and procedures.

 

SAFETY AND PROCESS SPECIFIC INFORMATION

N/A

PROCEDURE

    • Validation Project Numbers
      • When a new validation project is initiated, a validation project number is assigned to the project as follows:
      • The validation project identification takes the form of a six-digit number:

            AA-B-CCC.

Where:

AA =  Denotes the last two digits of the year in which the project is initiated/registered, i.e. 11 for 2011.

B     =      Denotes an automatically generated number. This number has no meaning at this stage

CCC =     Denotes sequential number for each year, starting from 001. 

  • Registration in Validation Database
    • The validation database is used to maintain a record of the work undertaken for the purpose of validation and the current validated state of a process (product), equipment or system.
    • The Validation database has two main sections the first section is the “Validation” section which contains details of the physical equipment, system or process that requires validation. The second section is the “Project” section which contains details of the activities undertaken to demonstrate a valid state. A valid state is considered to be the sum of all projects that are undertaken to demonstrate a “Validation Item” has met defined validation requirements.
Sample Document