Validation Master Plan in the pharmaceutical field
The pharmaceutical industry is one of the most regulated industries in the world, and for good reason: the drugs and treatments it produces have a direct impact on people’s health and well-being.
To ensure that pharmaceutical products are safe and effective, it is essential that all equipment and processes involved in their production are properly validated. This is where the Validation Master Plan (VMP) comes into play.
Validation Master Plan
What is the Validation Master Plan?
The PMV is a strategic document that defines and guides validation activities within a pharmaceutical organization.
Establishes the scope, approach, resources and schedule for specific validation activities, ensuring that all applicable regulations and standards are met.
Key Components of the PMV
All pharmaceutical areas, from research and development to production and distribution, require a systematic and documented approach to validation. The following are the essential phases of the LMP and how they are carried out:
URS (User Requirements):
- What is it? It is a document that details all the needs and requirements of the end user.
- Who carries it out? The end user’s technical department, normally the document is the result of all the departments involved in production (Production, Engineering and Maintenance).
- When does it take place? At the beginning of the validation process, before any equipment or system is designed or purchased.
- How is it done? Through meetings and discussions with all stakeholders to identify and document their specific needs and requirements.
DQ (Design Qualification):
- What is it? It is a verification that the proposed design complies with the URS.
- Who carries it out? Quality assurance department in collaboration with engineers and technical specialists
- When does it take place? After the design has been completed, but before any equipment or system is procured or constructed.
- How is it done? Comparing the proposed design with the URS to ensure that all requirements are met.
FAT (Factory Acceptance Test):
- What is it? It is a test performed at the supplier’s facilities to verify that the equipment or system complies with the URS and DQ.
- Who carries it out? The supplier, with the supervision of the customer.
- When does it take place? Before the equipment or system is shipped to the customer’s site.
- How is it done? Operating the equipment or system at the supplier’s facility and verifying that it meets all specifications.
SAT (Site Acceptance Test):
- What is it? It is a test performed at the customer’s premises to verify that the installed equipment or system complies with the URS and DQ.
- Who carries it out? The customer, with the assistance of the supplier if necessary.
- When does it take place? After the equipment or system has been installed. Normally the TSS is performed in conjunction with the first commissioning tests.
- How is it done? Operating the equipment or system at the customer’s premises and verifying that it meets all specifications.
IQ (Installation Qualification):
- What is it? It is a verification that the equipment or system has been installed correctly and meets the design requirements.
- Who carries it out? The quality assurance department in collaboration with the customer’s or external engineers and technical specialists.
- When does it take place? After the SAT and before the first process start-up tests of the equipment or system are started.
- How is it done? Inspecting and verifying that all parts of the equipment or system are correctly installed according to specifications.
OQ (Operational Qualification):
- What is it? It is a verification that the equipment or system is functioning properly under no-load (no product) operating conditions.
- Who carries it out? The quality assurance department in collaboration with the customer’s or external engineers and technical specialists.
- When does it take place? After IQ and before PQ
- How is it done? Operating the equipment or system under no-load operating conditions and verifying that it meets all specifications and requirements.
PQ (Process Qualification):
- What is it? It is a verification that the equipment or system is functioning properly under actual operating conditions with product.
- Who carries it out? The quality assurance department in collaboration with the customer’s engineers and technical specialists. It is not common for this to be done with external personnel.
- When does it take place? After the OQ
- How is it done? Operating the equipment or system under real operating conditions, producing the first test batches of each of the specialties.
The Validation Master Plan is essential to ensure that equipment and systems in the pharmaceutical industry meet the highest standards of quality and safety.
Each phase of the PMV is crucial and requires the collaboration of multiple specialties and experts.
At Global, we understand the importance of this process and, as part of our end-to-end service, we are committed to developing and carrying out the entire PMV in close collaboration with the end customer, ensuring that each stage is executed with precision and efficiency, and that all requirements and regulations are met to perfection.
