The VMP should be a concluding document which is to the point, precise and legible. The VMP should comprise data on as a minimum of the following:
- Validation Policy.
- Roles and Responsibilities for validation activities.
- Summary of facilities, machineries, systems, and processes to be validated.
- Documentation format: the format to be utilized for different protocols and reporting purposes.
- Planning and scheduling of different activities
- Change control process for Validation.
- Statement of reference to existing documents.
Objective of Validation Process
The objective of a validation process with appropriate documented DQ / IQ / OQ / PQ is to record and test the conformation, procedure and performance of the equipment / process or device within this domain.
The primary starting component of the validation of modern facilities, manufacturing systems or machines could be design qualification (DQ). The compliance of the design with GMP should be proved and recognized with documentation.
Installation qualification (IQ) should be implemented on new or changed facilities, manufacturing systems and machines. IQ should incorporate elements as under, but not be limited to the following:
- Installation of piping, equipment, services and instrumentation verified to current engineering drawings and specifications
- Collection and organization of supplier operating and working instructions and Requirements for maintenance
- Requirements for calibration
- Confirmation of construction’s materials.
Operational qualification (OQ) should proceed after Installation qualification. OQ should comprise of the following but not limited to:
Tests that have been established from operational and organizational knowledge of processes, systems and equipment
Tests to incorporate a state or a set of conditions covering upper and lower operating limits, often denoted as “worst case” scenario.
The conclusion of a effective Operational qualification should permit the finalization of operating and cleaning procedures, calibration, operator training and requirements for preventative maintenance requirements. It should allow a formal “release” of the facilities, machines, and industrial systems..
Performance qualification (PQ) should be done after effective conclusion of Installation and Operational qualification. PQ should have following elements, but just not limited to:
- Tests, utilizing production supplies, qualified substitutes or computer-generated product, that have been established from operational knowledge of the process and the facilities, systems and machines.
- Tests to incorporate a state or set of conditions encompassing upper and lower operating limits.
Even though PQ is designated as a distinct activity, it may in particular cases be suitable to perform it in combination with OQ.
Evidence should be obtainable to maintain and confirm the operating parameters and limits for the critical variables of the operating machine. Moreover, the cleaning, operating procedures, calibration, preventative maintenance, and operator training procedures and records should be available and documented.
Validation Protocol is presented consistent with the GMP (Good Manufacturing Practice) and GAMP 4 (Good Automated Manufacturing Practice) established and utilized in the pharmaceutical sector.
Essentially, even the cosmetics and the medical device industry are embracing these guiding principle so as to acquire a high quality machines that manufactures, handles and packs products directed for these industrial sectors.