SOP for Validation Master Plan | Validation Master Plan in Pharmaceutical Industry |
1.0 OBJECTIVE :
- To provide a guideline procedure for framing the validation plan for the equipment/ instrument/ utilities/ systems/ premises/ process used for manufacturing of the drug products.
2.0 SCOPE :
- This procedure is applicable to the various validations to be carried out for pharmaceutical products that require high degree of assurance of quality.
3.0 RESPONSIBILITY :
- Production Head,
- Quality Control Head,
- Quality Assurance Head
4.0 ACCOUNTABILITY:
- Quality Assurance Head
5.0 PROCEDURE :
- Validation Master Plan – VMP project the picture of plant as how the company has integrated cGMP into all aspects of manufacturing. This is periodic activity, whenever any major change is embarked upon.
- Prepare Validation Master Plan in standard format (Refer Annexure No. 01-Format for Validation Master Plan).
- Validation Master Plan cover following information;
- Introduction : It includes the Name and Address of the site with general information regarding the site like Facility description, Departments and Utilities required.
- VMP justifies the strategy, documenting the necessary program and is a “high level” document which provides a written program to ensure a continuing state of validation.
- Objective : The validation master plan (VMP) describe the company’s intentions regarding the validation of equipment, instruments, systems, utilities, facilities, materials, processes and personnel.
- Requalification/Revalidation:
- Requalification: It include the criteria under which the requalification of the Equipments / Instruments is to be carried out or the Requalification period of the Equipment / Instrument which is the earliest.
- Revalidation : It includes the criteria under which the revalidation of the process is to be carried out or the Revalidation period of the Process which is the earliest.
- Scope : Describe the systems and the methodology used to execute the various phases of the validation program which is applicable to all Critical Equipments / Instruments, procedures and other quality support systems used for the manufacturing, testing, labeling and packaging of the formulations.
- Validation Policy : The company’s overall policy, intentions, and approach to validation, including the validation of production processes, cleaning procedures, analytical methods, in-process control test procedures, and persons responsible for design, review, approval and documentation of each validation phase, should be documented.
- Validation Responsibilities : It include the following
- Production : It includes the responsibility of production department.
- Quality Control : It includes the responsibility of quality control department.
- Engineering : It includes the responsibility of engineering department.
- Facility And Equipment Qualification
- Facility Qualification : It includes the facility validation overview with facility description and the validation of the building which includes the civil work, painting work and the drainage system.
- Equipment Qualification : It includes the equipment/ instrument validation overview, equipment / instrument description, the critical equipments / instrument used in the manufacturing, testing, labeling and packaging process and the criteria of qualification which includes Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification.
- Utilities Qualification : It includes the utilities validation overview like water system, HVAC system, compressed air system, electrical systems and the utilities validation description.
- List of equipment/ instrument: It include list of equipment /instrument, which include the details regarding the equipment/ instrument required for process and testing.
- Revalidation Criteria: It include re-validation criteria, any process is an essential part of validation. It improves the quality of the product and increases the smoothness of the process. There are various conditions in which re-validation are required, like three year review date /Periodic re- validation and Re-validation after any change.
- Protocol: It include the persons who are responsible for the preparation, checking and approval of the protocols which are used for validation activities. It also includes the assurance that the information collected is timely, correct and is properly reviewed and approved by the members of the validation team.
- Preventive Maintenance Program : It includes the planned preventive maintenance program for premises and instruments / equipments as it is a essential part of the validation master plan and the responsible person to execute the program.
- Vendor Validation: It include the vendor validation to get the consistent, quality grade material from the vendor; vendor is to be validated. Vendor may be of raw material or packaging material.
- Process Validation : It includes the process validation overview, General description of the process procedures which are to be validated and different types of Process validations like prospective validation, concurrent validations and retrospective validations and their criteria to used.
- Cleaning Validation : It includes the details like introduction, importance of cleaning, acceptance criteria, scope, validation procedure, evaluation of cleaning procedures and the methods used for sampling ( rinse/swab) and testing.
- Laboratory Instrument Qualification: It include laboratory instrument qualification, which is required to establish the functional capabilities and reliability of the instrument for its intended use.
- Analytical Systems and Analytical Method validation : It includes calibration program of the qc instruments to ensure that the instruments are performed as it is to be intended. It also includes that the laboratory’s system of calibration and measurement are designed and operated to ensure that calibrations or tests and supporting measurements performed by the laboratory are traceable to national or international standards of measurements. it also includes the analytical method validation.
- Change Control Program: Any changes or the modification to the validation protocols, test reporting formats or documentation during validation and all changes to validated systems after validation is to be carried out through change control procedure.
- Validation Documentation: It include the validation documents, i.e., Quality Assurance department to manage all the documents generated during the validation process through the change control procedure.
- Validation Plan and schedule: It include the validation plan and schedule which include the plan and schedule to perform validation activity.
- Personnel Training Programme : It include the training program which include the training to be provided to the validation team members to execute the validation master plan.
- List of SOP : It include list of SOP which include the details regarding the SOPs required for equipment / instrument, process, validations and product should be demonstrated. It also includes the SOPs required for the supporting programs like change control, preventive maintenance, calibration, training and document control etc.
- Glossary of terms: It includes glossary of terms like change control, clean area, cleaning validation, re-validation, qualification etc.
- Worst Case study: A condition or set of conditions encompassing upper and lower processing limits and circumstances, within standard operating procedures, which pose the greatest chance of product or process failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure.
- Abbreviation: An abbreviation is a shortened form of a word or phrase. It consists of a group of letters taken from the word or phrase.
- Attachment: The attachment indicates the number of formats or records connected with the VMP.
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| SOP | Standard Operating Procedure |
| Q.A. | Quality Assurance |
| QC | Quality Control |
| VMP | Validation Master Plan |
| i.e. | That is |
| HVAC | Heating Ventilation and Air Conditioning |
7.0 ANNEXURES
| Annexure No. | Title |
| 01 | Format for Validation Master Plan |
8.0 SOP REFERENCES
- PIC/s Guidelines
END OF THE SOP
ANNEXURES :
Annex. No. 01 Format for Validation Master Plan
