Validation Master Plan in Pharmaceutical

Standard Operating Procedure of Validation Master Plan in Pharmaceutical is describe in this post.

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1. PURPOSE

To describe that,

1.1 What types of validation will be carried out in Pharmaceuticals

1.2 When all these validation will be performed.

1.3 When revalidation will be carried out.

2. SCOPE

All types of validation (e.g. equipment, system, method, cleaning and process) are under the scope of this SOP.

3. RESPONSIBILITY

3.1 All the Section Heads / HODs and supervisors are responsible for performing the duties assigned to them.

3.2 All the activities are monitored by Q.A Deptt.

3.3 Executive Q.A Validation helps the departments (where required) in conducting the validations.

3.4 Q.A Manager is responsible to ensure that all validations are being done and to evaluate the validation protocols and results.

4. MATERIAL & EQUIPMENT

Equipment, System and Process to be validated.

5. PROCEDURE

Following kinds of validation are conducted,

5.1 EQUIPMENT QUALIFICATION

5.1.1 Equipment Qualification is necessary to ensure that all critical Instrument / Equipment / System present in Pharmaceuticals premises meet user requirements and manufacturer specifications.

5.1.2 There are four types of Equipment Qualification as described below,

a. DESIGN QUALIFICATION (DQ)

• DQ is performed at the time of purchase of new Instrument / Equipment / System as per SOP for “Design Qualification”, all the information and data related to design qualification is recorded on “Design Qualification Protocol & Report”.

b. INSTALLATION QUALIFICATION (IQ)

• IQ is performed at the time of Installation / modification or relocation of critical Instrument / Equipment / System as per SOP for “Installation Qualification” , all the information and data related to Installation Qualification is recorded on “Installation Qualification Protocol & Report”.

c. OPERATIONAL QUALIFICATION (OQ)

• OQ is performed after IQ / modification / relocation or after out of spec. results of critical Instrument / Equipment / System as per SOP for “Operational Qualification”, all the information and data related to Operational Qualification is recorded on “Operational Qualification Protocol & Report”.

d. PERFORMANCE QUALIFICATION (PQ)

• PQ is performed after OQ / modification / relocation or after out of spec. results of critical Instrument / Equipment / System as per SOP for “Performance Qualification” all the information and data required is recorded on “Performance Qualification Protocol & Report”.

5.1.3 Equipment Qualification Team (includes Q.A Manager, Q.C Manager, Executive Q.A Validation, Sections Heads/ HODs & Maintenance Department) decides,

a. Which Instrument / Equipment / System will be subjected to Qualification Study,

b. Which type of Qualification is required by each Instrument / Equipment / System,

c. What tests to be performed for each Instrument / Equipment / System,

d. When each Instrument / Equipment / System will be subjected to Re-Qualification.

5.1.4 Re-Qualification of any category (i.e. after change or period of 5 years) is decided by Qualification Team after analyzing,

a. Previous history of machine (if available) including running history and no. of breakdowns etc. 

b. Criticality of the Instrument / Equipment / System,

c. Type of modification or maintenance,

d. Its area / environmental requirements, which can be taken from its manual or previous qualification data (if available).

5.1.5 Equipment qualification status of each section is updated by Q.A department on excel sheet “Equipment Qualification Log”. 

5.2 ANALYTICAL METHOD VALIDATION

5.2.1 Analytical Method validation of products is performed by Q.C department. 

5.2.2 Analytical method validation is carried out according to “SOP for Analytical Method Validation” by QC department.

5.2.3 Analytical method validation team comprises of following persons,

a. Q.C Analyst, 

b. Q.C Manager,

c. Executive Q.A Validation, 

d. Q.A Manager.

5.2.4 Periodic analytical method validation is carried out after every five years or earlier if required.

5.2.5 Analytical Method Validation status is maintained by Q.C department.

5.3 ASEPTIC PROCESS VALIDATION

5.3.1 Aseptic Process validation of sterile area is performed by Micro section. 

5.3.2 Aseptic Process validation is carried out according to “SOP for Aseptic Process Validation” by Micro section.

5.3.3 Aseptic Process Validation team comprises of following persons,

a. Microbiologist, 

b. QC Analyst

c. Q.C Manager,

d. Production Manager

e. Production Pharmacist

f. Executive Q.A Validation, 

g. Q.A Manager.

5.3.4 Periodic analytical method validation is carried out after every year or earlier if required.

5.3.5 Aseptic Process Validation status is maintained by Q.C department.

5.4 CLEANING VALIDATION

5.4.1 Cleaning Validation is performed to validate all procedures used for the cleaning of critical equipments present in manufacturing areas.

5.4.2 Cleaning validation is carried out as per SOP “Cleaning Validation” by Q.A department.

5.4.3 All the decisions regarding cleaning validation are taken by Cleaning validation team, which comprises of following persons,

a. Executive Q.A Validation, 

b. Production Manager,

c. Q.C Manager, 

d. Q.A Manager,

5.4.4 Periodic cleaning validation is carried out after every five years or earlier if required for equipment chain of the selected product. 

5.4.5 After cleaning validation completion, Report of Cleaning Validation is prepared by Executive Q.A Validation which is reviewed by Production Manager, Q.C Manager and approved by Q.A Manager.

5.4.6 Cleaning Validation status of each section is updated by Q.A department on excel sheet. 

5.5 WATER TREATMENT SYSTEM VALIDATION

5.5.1 Water Treatment System Validation is carried out as performance qualification of Purified Water along with Water for Injection and circulation loop.

5.5.2 Validation team is same as in equipment qualification. 

5.5.3 Performance Qualification is carried out as per SOP “Performance Qualification” and results are recorded on “Performance Qualification Report”.

5.5.4 Sampling and testing of Purified water along with Water for Injection is carried out as per sampling plan of “Performance Qualification Protocol” for twenty consecutive working days.

5.5.5 Periodic water system validation is carried out after period of 5 years or earlier if required.

5.6 HVAC SYSTEM VALIDATION

5.6.1 HVAC System Validation is carried out as performance qualification of HVAC systems.

5.6.2 Validation team is same as in equipment qualification.

5.6.3 Performance Qualification is carried out as per SOP “Performance Qualification” and results are recorded on “Performance Qualification Report”.

5.6.4 Sampling and testing of HVAC system is carried as per sampling plan of “Performance Qualification Protocol” for twenty consecutive working days. 

5.6.5 Re-validation is carried out after period of 5 years or earlier if required.

5.7 COMPRESSED AIR VALIDATION

5.7.1 Compressed Air Validation is carried out as performance qualification of Air Compressor.

5.7.2 Validation team is same as in equipment qualification.

5.7.3 Performance Qualification is carried out as per SOP “Performance Qualification” and results are recorded on “Performance Qualification Report”.

5.7.4 Sampling and testing of Compressed air is carried as per sampling of “Performance Qualification Protocol” for twenty consecutive working days.

5.7.5 Re-validation is carried out after period of 5 years or earlier if required.

5.8 STEAM SYSTEM VALIDATION

5.8.1 Steam System Validation is carried out as performance qualification of Steam Generators.

5.8.2 Validation team is same as in equipment qualification.

5.8.3 Performance Qualification is carried out as per SOP “Performance Qualification” and results are recorded on “Performance Qualification Report”.

5.8.4 Sampling and testing of Steam is carried out as per sampling plan of “Performance Qualification Protocol”.

5.8.5 Re-validation is carried out after period of 5 years or earlier if required.

5.9 PROCESS VALIDATION

5.9.1 To determine that process consistently performs as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that the process meets pre-determined specifications.

5.9.2 Following are different types of process validation,

a. PROSPECTIVE PROCESS VALIDATION

• Prospective process validation is carried out on the products which are at developmental stages and currently not been carried out in Pharma.

b. CONCURRENT PROCESS VALIDATION

• Concurrent process validation is carried out by Q.A Deptt. for running batches of products to demonstrate that the process meets pre-determined specifications.

• Concurrent Validation status is updated by Q.A Deptt. on excel sheet “Product list for Process Validation”. 

c. RETROSPECTIVE PROCESS VALIDATION

• Retrospective process validation is carried out by Q.A Deptt. for pre-marketed products with stable manufacturing process to demonstrate that the process has been performed satisfactorily and consistently over the time and therefore can be counted on to deliver products of same quality in the future.

• Retrospective Validation status is updated by Q.A Deptt. on excel sheet “Product list for Process Validation”.

5.9.3 Periodic re-validation may be carried out after every five years or earlier if required for each product to ensure that they remain capable of achieving the intended results and to assess process changes that may occur gradually over a period of time, or because of wear and tear of equipment or because of issues in Annual Product Reviews.

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