1 / 22

Validation

Supplementary Training Modules on Good Manufacturing Practices. Validation. Validation. Part I: Introduction and The Validation Master Plan (VMP) Part 2: Cleaning validation Part 3: Process validation Part 4: QC-related validation Part 5: Review and summary.

elmo-wyatt
Download Presentation

Validation

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Supplementary Training Modules on Good Manufacturing Practices Validation

  2. Validation Part I: Introduction and The Validation Master Plan (VMP) Part 2: Cleaning validation Part 3: Process validation Part 4: QC-related validation Part 5: Review and summary

  3. Validation Objectives of Part 1 • To provide an introduction to the subject of Validation • To provide information on the Validation Master Plan

  4. Validation Introduction Three basic principles of Quality Assurance: • Quality, safety, effectiveness • Cannot inspect quality into a product • Processes must be under control

  5. Validation WHO validation definition • The documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expected results.

  6. Validation Qualification or validation? • A system must be qualified to operate in a validated process • Qualify a system and/or equipment • Validate a process • Qualification versus validation, e.g. you qualify an autoclave, whereas you validate a sterilization process

  7. Validation Qualification and validation work require: • Collaboration of experts • Budget • Meticulous and careful planning A Validation Master Plan helps the manufacturer and inspectorate

  8. Validation The Validation Master Plan (VMP) • Philosophy • Content • Strategy

  9. Validation Validation Master Plan • Recommendation only • Cover manufacturer’s validation policy and needs • Provides information on validation organization • It should describe: • why? • what? • where? • by whom? • how? • when?

  10. Validation Validation Master Plan • Prospective validation • Concurrent validation • Retrospective validation • Revalidation • Change control

  11. Validation The VMP helps: • Management • Validation team members • Project leaders • GMP inspectors

  12. Validation The VMP • Identifies validation items (products, processes, systems) • Definesnature and extent of testing expected • Outlines test procedures and protocols • Summary document • Management agreement

  13. Validation Validation Activities in VMP • Every validation activity included • Revalidation • Validation of new process cycles • Large validation projects have separate VMPs • Include reasonableunexpected events

  14. Validation The VMP: • Enables overview of entire validation project • Lists items to be validated with the planning schedule as its heart • Is like a map

  15. Validation The “Introduction” to the VMP • Validation policy • Project scope • Location and timing (including priorities) • Validation procedures • Standards

  16. Validation VMP should state who is responsible for: • Preparing the VMP • The protocols and SOPs • Validation work • Report and document preparation and control • Approval/authorisation of validation protocols and reports in all stages of validation process • Tracking system • Training needs in support of validation

  17. Validation VMP should contain: • Cross references to documents • Specific process considerations • Specific characteristicsbriefly outlined • Validation list (What to validate) • premises, systems and equipment • processes • products

  18. Validation VMP should contain: • Descriptions of • plant (where to validate) • processes • products • Personnel attributes • expertise and training • Key acceptance criteria

  19. Validation VMP should contain: • Format for protocols and other documentation • List of relevant SOPs (How) • Planning and scheduling (When) • Location (Where) • Estimate of staffing requirements (Who) • A time plan of the project (When) • Annexes

  20. Validation VMP should contain change control • Policy and procedure • Risk assessment • Authorization • Failure to properly document changes to the system means invalidation of the process

  21. Validation Changes that require revalidation • Software changes;Controllers • Site changes; Operational changes • Change of source of material • Change in the process • Significant equipment change • Production area changes • Support system changes

  22. Validation In summary, a VMP should contain at least: • Validation policy • Organizational structure • Summary of facilities, systems, equipment, processes to be validated • Documentation format for protocols and reports • Planning and scheduling • Change control • Training requirements

More Related