VALIDATION

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DOCUMENTATION

Complete documentation of all specifications,

Procedure (SOP’s), Protocol, Activities, Data record

system, validation documentation, certification and

record evaluation.

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EQUIPMENT

Appropriate design, Capacity matching with batch

size / work load, Sufficient in number for optimum

utilization, Effectively validated, calibrated and

maintained.

• Validation

• Calibration

• Environment Control

• Document Control

• Change Control

• Quality Control

QUALITY ASSURANCE

What is Validation ?

Documented proof that everything, within reasonable certainty, that is involved in the manufacture of a product is under control.

This includes the facility, the environment, the materials, the equipment and the processes including manufacture and cleaning procedures.

WHY VALIDATION

To Establish by documented Evidence to provide a high degree of assurance that a planned process will consistently perform according to the intended specified outcomes

MASTER VALIDATION PLAN

It is a document pertaining to the “whole facility” that describes which Equipment. Systems. Methods and Processes will be validated and when they will be validated.It also includes Re-Validation- why and when

Types of Validation

Prospective Validation

Validation conducted before manufacturing a new product or manufacturing a product after making changes in the process which can have a gearing on the products quality

Types of Validation..contd.

B. Retrospective Validation

Validation of a process already in production based upon accumulated production, testing & control data, i.e., past records in the possession of the manufacturer

VALIDATION CONSISTS OF

Design Qualification - DQ

Installation Qualification - IQ

Operational Qualification - OQ

Performance Qualification - PQ

DESIGN QUALIFICATION

Necessary when planning and choosing equipment or systems to ensure that components selected will have adequate capacity to function for the intended purpose.

Example- selection of steam generator.

Master Validation Plan must address sequence of DQ.

INSTALLATION QUALIFICATION

Qualification of a piece of equipment should check for the requirements that are mentioned in the DQCompare with the purchasing information and invoice dataRequirements- Name, description, model, identification numbers, location, utility requirements, connections, safety measures 0f the system

IQ - continued

During Installation Qualification it should be verified that the following matches the purchase specification:Drawings,manuals,spare parts list,vendor address and contact number,Other pertinent documentation.

Simple Example of Installation Qualification

1. Equipment: _________________

2. Model: _________________

3. Manufacturer: _________________

4. Date of Purchase: _________________

5. Date of Installation _________________

6. Calibration done by _________________

OK/Damage/Inadequate

All fastenings8.

OK/Damage/Inadequate

Electrical Fittings

7.

OK/Damage/Inadequate

Limit Switches6.

OK/Damage/Inadequate

Covers Working5.

OK/Damage/Inadequate

Switches4.

Not / As per requirement

Dimensions3.

OK/Damage foundPhysical Damage

2.

Remarks

Provided/Not Provided

Manual 1.

The details of the equipment should be critically tallied with the order placed with the vendor. Needless to add the order placed should be as per the Design Qualification (DQ). All critical components of the equipment should be tabulated and only after successful verification should the equipment verified as conforming to IQ

OPERATIONAL QUALIFICATIONS

Outlines the information required to provide evidence that all the components of a system or equipment operate as specified.

OPERATIONAL QUALIFICATIONS…contd.

This involves testing of all:normal operation controls,all alarm points,all switches,all displays,interacting controls,any other indications of operation & functions

OQ - c o n t i n u e d

Specifications and acceptance criteria must be defined for all operation

Should provide a listing of SOPs, reference to specific manual instructions for operation, maintenance and calibration

Simple Example of Operational Qualification

Equipment: _________________ Model: _________________Manufacturer: _________________Date of Purchase: _________________Date of Installation _________________Calibration done by _________________ List of Calibrating Equipment & Instrument

(enter list of all instruments used for calibration along with details of the

instruments)

Simple Example of Operational Qualification

contd.• Documents required

(enter list of all documents used for the calibration)

RemarksResultCalibrated byControl/AlarmSl. No.

Calibration Record

Simple Example of Operational Qualification

Contd.

Control & Check Parameters

RemarksDeviationObservationRangeParametersSl. No.

Results & Conclusion

Signature

Performance Qualification

To be carried out after both IQ and OQ have been successfully completed

Describes the procedures for demonstrating that a system or piece of equipment can consistently perform and meet required specifications under routine operation, and where appropriate, under worst case situations.

PQ - c o n t I n u e d

Describe the preliminary procedure requiredDetailed performance testacceptance criteria for each testall supporting systems and procedures should have been validated (e.g.. Steam system should be validated before autoclave validation)

Process Validation

Performance (How to do it)

Process : Run the process according to SOP three times and record all required data.Deviations to the procedures must be recorded on the data record forms.

Analytical tests: Perform the routine tests associated with the process according to SOP, Test results must be approved by the QC.

Evaluation

Attach all data record forms and charts.Perform all calculations and analyses

which are predetermined and approved.Compare with the accepted criteria.

Prepare Deviation Report

Deviation if any must be recorded and justification for acceptance, if

any, mentioned.

Prepare Process Validation Report

This must mention start date, completion date, observations, problems encountered,

completeness of information, summary of the deviation report, results of test, comparison

with the accepted criteria, other relevant data.Conclusion should take into account individual

as well as the results of three consecutive validation runs.

Approval and Acceptance

QA should review and approve the report.The Process must meet all specifications

For three consecutive runs

Process Validation Requirements

Low-dose tablets and capsules containing highly active substances: validation of mixing and granulation in relation to content uniformity.Other tablets and capsules: Validation of tablet compressing and capsule filling in relation to uniformity of mass.

2. Non- sterile production

All processes affecting sterility and manufacturing environment must be validated; the most important is the sterilization stage.

Existing 1. Process designed to render a product sterile

Every new process must be validated before approval for routine production

New

RequirementsType of process Validation

Example of Process ValidationManufacture of Paracetamol tablets

Procedure of receipt of RM to the plantProcedure of storage and testingProcedure of issue of material to Prod.Actual manufacturing:WeighingSievingmixingGranulationDrying

Example of Process Validation

LubricationCompression

Release & Packing

Each of the above operations have to be validated against the requirements of the procedure and documented!!!!

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