eqiupment validation

A SEMINAR ON PHARMACEUTICAL

EQUIPMENT VALIDATION

Prepared byShivam ThakoreAnkit PatelHarsh Oja

Guided byMr. Nihar ShahAssociate professorLJIP, Ahmedabd

04/11/2023Department of Pharmaceutical Technology,

LJ institute of Pharmacy,Ahmedabad 1

What is Validation? According to FDA, validation is method to

establish documented evidence which provides a high degree of assurance that specific process will consistently produce a product meeting its predetermined specification and quality attributes.

It is a quantitative approach needed to prove quality, functionality and performance of pharmaceutical manufacturing process. It is very broad term.

It will apply to individual parts of pharmaceutical equipment and also to the pharmaceutical process as a whole.



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According to WHO, Validation is the collection and evaluation of data, beginning at the process development stage and continuing through the production phase, which ensure that the manufacturing processes - including equipment, buildings, personnel and materials - are capable of achieving the intended results on a consistent and continuous basis.


LJ institute of Pharmacy,Ahmedabad

Related terms… Validation: Usually applies to a process. It

is the overall action of proving, in accordance with the principles of GMP, that any process, equipment, material, activity or system actually results in a test or process that will perform as the user has specified.

Qualification: Usually applies to equipment. It is the stepwise action of proving that any particular premises, systems and/or piece of equipment will actually lead to the expected results (Qualification is a part of validation. Validation will

include other parts such as SOPs for all the operations associated with the equipment and training on the use of the equipment).



Qualification (Equipment validation)

It is performed to ensure that equipment produces consistent results with minimal variation without compromising the integrity of the product and the persons operating the equipment.

It is performed to establish confidence that process equipment and ancillary systems are capable of consistently operating within established limits & tolerance.

It is generally divided into five parts of qualification.



Various phases of Qualification

Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Requalification (RQ)



Design Qualification (DQ) Basically is presets the specification required for

the equipment. It defines the functional and operational

specifications of instrument & details for the conscious decisions in the selection of the supplier.

It is performed prior to the equipment purchase and describes the features required for the equipment to installation.

The Design Qualification is the only document that is going to confirm that the design will work. It must be carried out by Qualified people who can challenge the design performance.



Key Considerations Equipment capabilities:

SpeedCapacityTemperature

Requirements:VoltageSize limitationOperational specifications

Features:Self CalibratingService Contracts



List of steps to be included in DQ Description of analysis problem Description of intended use of the

equipment, its environment. Preliminary selection of the functional and

performance specifications. Supplier selection. Final selection of equipment. Final selection of supplier and equipment. Development & documentations of

specifications

04/11/2023 Department of Pharmaceutical Technology, LJ institute of Pharmacy,Ahmedabad 10

It generally indicates the requirements that the equipments must meet in order to work specifically.FOR EXAMPLE Equipment description eg A500/540/560

Automatic Centrifuge Specification Reasons for selection of this model

Electrical requirements/ losses Tolerance/performance Maintenance/Cleaning Other

Person responsible for this selection



Installation Qualification Installation Qualification (IQ) execution verifies

that the equipment and its ancillary systems or sub-systems are present and have been installed in accordance with installation drawings and or specifications.

It established that the instrument is received as designed and specified, that it properly installed in the selected environment & this enviroment is suitable for the operation and use of instrument.

It requires the team effort by The vendor The operating department The project team



IQ should be performed on all new or modified facilities, systems and equipments.

FDA states that “IQ includes examination of equipment design; determination of calibrations, maintenance and adjustment requirements; & identifying critical equipment features that could affect the process and product,Information obtained from these studies should be used to establish SOP’s covering equpiment calibrations, maintenance, monitoring and control ”



Key Considerations All unit operations are installed as per

specifications & design drawing. Support systems like instrument calibration

programs, preventive maintenance procedures & obeying SOP’s are addressed.

Verification that established specification have been complied during construction & installation.

Verification of construction materials, examination and documentation of welds.

Inspection for dead legs, pipe slopes. Verification of SS pasivation.



Verify that the equipment complies with National electrical codes

Verify that all alarms and visual displays are operational and correct.

Verify that if appropriate, the correct versions of software are used.

Identify and verify that serial numbers and model number of all equipment or component parts is as listed in the installation documentation.

Review all calibration certificates for the equipment.

Verify that the ambient conditions are appropriate for the operation of the equipment.



Also following has to be checked Delivery date? Manual received? (hardcopy/Electronic

format) Location for installation Name of installer. Power up worked? (Y/N) Self checked passed? (Y/N) Service/ Calibration plans

established(Details) Other





Ensure voltages are correct.Ensure power is supplied to all equipment.Verify operation of lights and display.Ensure floor loading is even.

Operational Qualification The QO is a process of demonstrating that

an instrument will function according to its operational specification in the selected environment.

includes a review of the operating manual and verification that all functional aspects of the equipment are performing as intended throughout all anticipated operating ranges. (This is a good time to start writing the SOPs pertaining to the equipment.)



Key Considerations Testing of alarms. Testing of interlocks and permissive

conditions. Testing of database or data storage integrity. Verification & review of the functionality of

the equipment with GMP regulations. Challenge of software, where required; Testing of security levels to prevent

unauthorized access; Testing to verify and document Power loss

Recovery. Testing of all interfaces between separate

pieces of equipment. Testing for Electromagnetic interference and

compatibility. 04/11/2023

Department of Pharmaceutical Technology,LJ institute of Pharmacy,Ahmedabad 19

http://www.validation-online.net/validation-protocol-standards.html

http://quality.validation-online.net/

http://quality.validation-online.net/page196.html

Also… Describe the specification to be tested.

Drying temperature, Paddle/basket rpm Accuracy of all the specification

Has equipment been calibrated? By whom (attached documented evidence)

Has an SOP been written? If not then do it right now before usage of

equipment. Process description

Details of process Study critical parameters.

Temperature, chopper, baffles etc



Operational Qualification is essentially acceptance testing and should serve as the basis for final payment.

So imagine the importance of this step…



Performance Qualification (PQ)

PQ is the process of demonstrating that an instrument consistently performs according to the specification appropriate for its routine use.

PQ is performed after successful completion of the IQ & OQ.

The testing verifies that the performance specified in the Design Specification is being delivered.



Key considerations It should be performed under conditions that are

similar to routine sample analysis. PQ should be performed on the daily basis or

whenever the equipment is being used. Generally, PQ can mean suitable testing of

equipment, where critical key system parameters are measured and compared with documented preset limits.

Definition of performance criteria and test procedures.

Determination of the test intervals. Everyday Every time the system is used Before, between, after series of runs



Once the validation team has completed all the steps (DQ,IQ,OQ,PQ) of equipment, the equipment is said to be validated.

Validation individual will circulate the completed documents for final comments and approval. Any comments or correction by the sign off committee will be followed by validation individual.

Once the documents are signed off, the validation individual will transfer all documents to operating department of the equipment.



Requalification (RQ)



References Parikh R K, Makwana Vijay, “Validation of

pharmaceutical process” LM college of Pharmacy,Ahmedabad.

www.ncsu.edu/checs/media/Validation_Tutorial.ppt/ accesed at 15th April 2013

www.gmpsop.com/.../val-090_equipment_validation_guideline_sam.../ accesed at 15th April 2013

www.askaboutvalidation.com/.../forumdisplay.php?...EQUIPMENT-.../ acessed at 15th April 2013

www.pharmout.com.au/services/validation/equipment-validation.shtml/accesed at 15th April 2013



http://www.ncsu.edu/checs/media/Validation_Tutorial.ppt/accesed




http://www.gmpsop.com/.../val-090_equipment_validation_guideline_sam.../





http://www.askaboutvalidation.com/.../forumdisplay.php?...EQUIPMENT-.../





http://www.pharmout.com.au/services/validation/equipment-validation.shtml/accesed









THANKS FOR THE ATTENTION,

LJIP, AHMEDABAD

eqiupment validation

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