MASTER VALIDATION PROGRAM

Contents:

1. Project Description.
2. Purpose.
3. Policy.
4. Validation Team Members.
5. Responsibility of Validation Team Members.
6. Summary of process and Equipment’s to be validated.
7. Planning and Scheduling.
8. Document Format.
9. Document Numbering System.
10. Change Control.

1. Project Descriptions

1.1. The validation master plan is a summary document stating the intention and the methods to be used to establish the adequacy of the performance of the equipment, systems, controls and process to be validated. It is approved by the quality assurance, validation, production, and engineering groups.

2. PURPOSE

2.1. The purpose of this document is to provide the guidelines for the preparation of validation program and to establish validation requirements.

3. Policy

3.1. Our policy is to initiate the validation program simultaneously in all facets of the facility. The area covered by this project includes Production, Quality Assurance, Quality Control and supporting facilities.

3.2. This Program will be conducted in two phases,

• Phase 1:- Development of validation SOPs.
• Phase 2:- Implementation of SOPs on experiment basis.

4. Validation Team Members

4.1. All the officers from Production, Quality Assurance and Quality Control are the members of the validation team.

5. Responsibility of validation team

5.1. Validation Plan is designed and executed with the collaboration of all departments (Production, QC and QA) and individuals:

SR No	Validation program	Responsibility	Department
1	Heating ventilation air conditioning system	QAM	QA
2	Water system	Production Pharmacist	Production
3	Cleaning validation	QAM	QA
4	Analytical Methods	QCM	QC
5	Machines and equipments	QAM	QA
6	Non sterile Process Validation	PM	Production
7	Sterile processes validation	PM	Production

6. Summary of Processes and equipment’s to be validated.

6.1. Heating ventilation air conditioning system

• Performance Qualification
• Viable Monitoring
• Non-Viable Monitoring
• Pressure Differentials
• Temperature and Humidity
• Air Velocity (Air Changes)
• Air Flow Patterns

6.2. Water system

• Installation Qualification of complete water system.
• Operation Qualification of All water treatment units.
• Performance Qualification of All water treatment units.
• Regeneration process of DI Plant Validation.
• Annual Performance of water treatment system.
• Sanitation of Purified Water production, Storage and distribution system validation.

6.3. Cleaning

• Cleaning validation of non-sterile area
• Cleaning validation of machines and equipment’s of non-sterile area.
• Cleaning validation of sterile area
• Cleaning validation of machines and equipment’s of sterile area.
• Cleaning validation of uniforms of sterile area.

6.4. Analytical Methods

·         Applicable only where, Analytical methods are not included in pharmacopoeias.

     Note: methods referenced from official pharmacopoeias are validated. 

6.5. Machines and equipment’s

·         Performance Qualification

6.6. Non sterile Process Validation

6.6.1.        Solid Dosage forms

• Granulation
• Drying
• Mixing
• Compression
• Filling

6.6.2.        Semisolid Dosage forms

• Mixing
• Filling 

6.6.3.        Weighing Process Validation

6.6.4.        Sterile processes validation

• Mixing
• Autoclaving
• Aseptic Filling Validation
• Filter integrity testing
• Filtration Validation
• Area Sterility Validation 

7. Planning and Scheduling

7.1. Phase 1

7.1.1.        According to our policy phase 1 is for SOPs developments, so responsibilities and targets are given below

Sr. No.	Validation SOPs	Target Dates	Status
	Performance Qualifications of HVAC system
	Installation Qualification of complete water system.
	Operation Qualification of All water treatment units
	Performance Qualification of All water treatment units
	Regeneration process of DI Plant Validation
	Annual Performance of water treatment system.
	Sanitation of Purified Water & WFI production, Storage and
	Cleaning validation of non-sterile area
	Cleaning validation of machines and equipment’s of non-sterile area
	Cleaning validation of sterile area
	Cleaning validation of machines and equipment’s of sterile area
	Cleaning validation of uniforms of sterile area
	Performance Qualification of all machines and equipment’s in facility.
	Solid Dosage forms
	Semisolid Dosage forms
	Sterile processes validations SOPs

7.2. Phase 2

7.2.1.        Perform validation, write and submit reports.

7.2.2.        Responsibility: - QA Department will be responsible for compliance of validation program.

 1^st Validation Schedule

SR No	Records of Validation SOPs	Target Dates
1	Records of Performance Qualification of HVAC system
2	Installation Qualification report of water treatment system.
3	Operational Qualification Report of water treatment system.
4	Regeneration process of DI Plant Validation Report.
5	Performance Qualification report of Tap water systems.
6	Performance Qualification Report of DI water Plant.
7	Performance Qualification Report of RO water Plant.
8	Performance Qualification Report of WFI water Plant.
9	Annual Performance report of water treatment system.
10	Sanitation report of Purified Water treatment system and distribution pipes.
11	Cleaning validation of non-sterile area
12	Cleaning validation of machines and equipments of non-sterile area
13	Cleaning validation of sterile area
14	Cleaning validation of machines and equipments of sterile area
15	Cleaning validation of uniforms of sterile area
16	Performance Qualifications
17	Solid Dosage forms
18	Semisolid Dosage forms
19	Sterile processes validations Report.

Validation Schedule for year 2017

Sr. No.	Records of Validation SOPs	Previous Validation Dates	Target Dates
1.	Records of Performance Qualification of HVAC system
2.	Installation Qualification report of water treatment system.
3.	Operational Qualification Report of water treatment system.
4.	Regeneration process of DI Plant Validation Report.
5.	Performance Qualification report of Tap water systems.
6.	Performance Qualification Report of DI water Plant.
7.	Performance Qualification Report of RO water Plant.
8.	Performance Qualification Report of WFI water Plant.
9.	Annual Performance report of water treatment system.
10.	Sanitation report of Purified Water treatment system and distribution pipes.
11.	Cleaning validation of non-sterile area
12.	Cleaning validation of machines and equipments of non-sterile area
13.	Cleaning validation of sterile area
14.	Cleaning validation of machines and equipments of sterile area
15.	Cleaning validation of uniforms of sterile area
16.	Performance Qualifications (Machines)
17.	Solid Dosage forms
18.	Semisolid Dosage forms
19.	Sterile processes validations Report.

Any process previously validated shall be revalidated under following conditions:

o   Change in process/material

o   Change in HVAC

o   Change or reparation of any machine

o   After every two (2) years

All officers shall submit the SOPs and records to QA department at or before the target date. Quality Assurance department shall prepare a master report.

8. Documents format

8.1.Copy approved document format for sop’s already provided to department heads.

8.2.Following contents shall be part of all validation sop’s.

      Contents of SOP

• Objective

• Purpose
• Scope
• Responsibility
• Frequency
• Revalidation
• Procedure
• Acceptance Criteria
• Attached Documents (Annexure + Report)

9.       Document numbering system

9.1.Document numbers shall be issued to all sop’s and records as per company document master list protocol.

10.   Change control

10.1.          Change control protocols are implemented on all areas where validation activities are done.

10.2.          Prior to initiation of change, review of proposed or actual changes that might affect validated status and cause corrective action to be taken shall done, so that the system retains its validated state.