How to implement a Good Validation Master Plan (VMP)

Definition

Validation Master Plan is an approved written plan of objectives and actions stating how and when a company will achieve compliance with the GMP requirements regarding validation. It is a document which defines the intentions and the methods that are related with validation of facilities, utilities, system, equipment, instruments, materials, analytical methods, It Systems, cleaning procedures and processes.

VALIDATION MASTER PLAN

The VMP describes the general validation program and strategies to demonstrate that the facility for the manufacturing processes of different drug product forms is capable of meeting the process parameters in a repeatable and controllable manner.

The validation Master Plan ensures that validation and qualification activities are carried out as per protocols. The Validation Protocol is then a written plan of actions stating how validation and qualification activities will be conducted. It will specify who will conduct the various tasks and define testing parameters; sampling plans, testing methods and specifications; will specify product characteristics, and equipment to be used. It should specify the minimum number of batches to be used for process validation studies; it also specifies the acceptance criteria and who will sign/approve/ disapprove the conclusions derived from such a scientific study or activities.

Validation expectations

After the execution and the completion, the validation protocols allow to determine whether the equipment, systems, methods and processes meet the following requirements:

  • Design specifications
  • suitability for intended uses and applications
  • cGMP design criteria
  • Regulatory expectations and requirements
  • Safety criteria and requirements
  • Capability of consistent reproducibility of the process that produces a product that fits for use

Validation Master Plan generic content

A typical VMP shall contain:

  • VMP Introduction, Scope, and Objectives
  • Responsibilities
  • Manufacturing Process Description
  • Process Knowledge Management
  • Risk Assessment and Evaluation
  • Data Integrity, Governance and Management
  • Site Facility Overview and Design
  • General Validation / Qualification Approach
  • Facility Heating, Ventilation, and Air Conditioning (HVAC)
  • Utilities
  • Equipment
  • Computer Systems
  • Products and Manufacturing Processes
  • Cleaning and Sanitation
  • Analytical Methods
  • Projects – Current and Completed
  • Facility Heating, Ventilation, and Air Conditioning (HVAC) Qualifications
  • Utilities Qualifications
  • Equipment Qualifications
  • Computer Systems Qualifications
  • Products and Manufacturing Process Validations
  • Cleaning Validations
  • Analytical Methods Validation
  • Maintenance Program
  • Deviation and Change Control Management
  • Periodic Review Procedure

Conclusion

The VMP is intended to project a picture of how your company has integrated current Good Manufacturing Practices (cGMP) as promulgated US FDA, MHRA, Health Canada, EU GMP, PIC\S and WHO into all aspects of the manufacturing process. The Validation Program is designed to proactively assure GMP compliance from facility development through the distribution of final product.

References

  • FDA cGMPs 21 CFR Part 210 and 211 : Current Good Manufacturing Practices
  • WHO Annex 6 GMP for Sterile Pharmaceutical Products
  • FDA’s Guidance for Industry: Sterile Drug Products Produces by Aseptic Processing –  Current Good Manufacturing Practice”
  • FDA’s “GMP’s for the 21st century”
  • WHO GMP for pharmaceutical products
  • ISPE GAMP 5 – Good Automated Manufacturing Practices
  • Health Canada – Good manufacturing practices guide for drug products (GUI-0001)
  • Health Canada – Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119)

About the authorKossi Molley, Chemist, LSSBB