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VALIDATION

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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 sequence of DQ. Plan must address

INSTALLATION QUALIFICATION
Qualification of a piece of equipment should check for the requirements that are mentioned in the DQ Compare with the purchasing information and invoice data Requirements- 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 _________________ _________________ _________________ _________________ _________________ _________________

1. 2. 3. 4. 5. 6. 7. 8.

Manual

Provided/Not Provided

Remarks

Physical Damage OK/Damage found Dimensions Switches Covers Working Limit Switches Electrical Fittings All fastenings Not / As per requirement OK/Damage/Inadequate OK/Damage/Inadequate OK/Damage/Inadequate OK/Damage/Inadequate OK/Damage/Inadequate

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 QUALIFICATIONScontd.
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)

Calibration Record
Sl. No. Control/Alarm Calibrated by Result Remarks

Simple Example of Operational Qualification


Contd.

Control & Check Parameters


Sl. No. Parameters Range Observation Deviation Remarks

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 required Detailed performance test acceptance criteria for each test all 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


Type of process Validation New Requirements Every new process must be validated before approval for routine production All processes affecting sterility and manufacturing environment must be validated; the most important is the sterilization stage. 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.

Existing 1. Process designed to render a product sterile 2. Non- sterile production

Example of Process Validation Manufacture of Paracetamol tablets


Procedure of receipt of RM to the plant Procedure of storage and testing Procedure of issue of material to Prod. Actual manufacturing: Weighing Sieving mixing Granulation Drying

Example of Process Validation


Lubrication Compression Release & Packing

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

Thanks

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