VALIDATION OF EQUIPMENTS

Presented by N.Lakshmi Priya Dept. of PharmaceuticsM.Pharmacy 1st Year

CONTENTSDefinitonObjectivesParts of equipment validationAssembling of protocolEquipments that are validatedReferences

Validation means rectification or confirmation.It establishes a documented program of specified

and reliable performance.

Definition According to USFDA Validation is a documented program,which

provides a high degree of assurance that a specific product meets its pre-determined specifications and quality attributes

• Improvement of overall production reliability and availability

• Safety• Lower repair costs• Elimination of premature replacements• Less standby equipment• Identification of high maintenance cost• Reduction of variation in results• Greater confidence in reliability of results

OBJECTIVES

Parts of validation/Qualification

Principle Equipment must be designedconstructedadapted maintained to perform the operations which are to be carried out.

Equipment layout and design must aim to minimise the risk of errors to permit effective cleaning and maintenance To avoid cross contamination,dust and dirt build up. any adverse effect on quality of products. Equipment must be installed to minimise risk of errors. minimise risk of contamination

CONTROL LABORATORY EQUIPMENTEquipment and instruments- suitable for the tests to be confirmed.Defective Equipment- Removed LabelledWashing,cleaning and drying- on scheduled basis,procedures and records Design,no source of contamination

QUALIFICATION POLICY FOR EQUIPMENTS TO BE VALIDATED

Instruments used in production and quality control.New systems and equipmentQualification done in accordance with

predetermined and approved qualification protocols.The results have to be recorded and reflected in

qualification reports.

DESIGN QUALIFICAITON functional and operational specifications of the instrument

and details in the selection of the supplier.What are to be considered?? analytical problems use of equipmentEnvironmentFunctional and performance specifications.

INSTALLATION QUALIFICATION It tells whether the equipment is properly installed and

whether it is suitable for that environment. Equipment management group

Support groups

plant engineering group

Documented records for the installationInstallation qualification report includes details,e.g. The supplier and the manufacturer system or equipment name Model and serial number Date of installation

OPERATIONAL QUALIFICATION - demonstrates that an instrument will function according to its

operational specification in the selected environment. DOCUMENTED RECORDSTraining of operators provided-training recordsSystems and equipment released for routine use after

completion of operational qualification,provided that All calibration,cleaning,maintenance,training and related tests and

results were found to be acceptable.

PERFORMANCE QUALIFICATION -demonstrates that an instrument consistently performs

according to a specification appropriate for its routine use.

DOCUMENTED RECORDS- performance qualification report

Shows satisfactory performance over a period of time, carried out long to prove that the equipment is under control and turns out product of specified quality consistently.

CONTENT OF EQUIPMENT VALIDATION 1.Application S.O.P’s2.Utilisation list 3.Process description4.Test instrument utilised 5.Test instrument calibration 6.critical parameters7.Test function 8.Test function summaries

• The Validation process is regulated by the guidelines & restrictions set forth by the FDA.

• CFR: Code of Federal Regulationcreated by US Government that sets guidelines pertaining for food and drugs.

• Validation rules are given in the 21 CFR Part 210 & Part 211 as the part of cGMP.

ROLE OF FDA IN EQUIPMENT VALIDATION

Assembling of a validation protocolDocumented formats or protocolsHelps in systematising the study of equipment

validation.Different formats have been specified for

designing protocols and carrying out operational qualification.

PURPOSE This procedure details the assembly and contents of

the validation protocol for use in validation testing.PrincipleThis protocol is generated by a validation

specialist/engineer.Protocol section contains required forms and

procedures.Protocol describes “how” the system is to be

validated while forms document these procedures and provide a written record of the processes.

TESTING PROCEDURES:Sections of a standardised protocol:• Table of contents List of standardised sections unique testing procedures • Approval page pre-approval selection final approval selection• Description • Statement of purpose• Standard operating procedures• calibration

Installation qualification includes Inspection checklist Installation checklist1.Inspection checklist

INSTRUCTIONS Explains how this section is physically executed

Table of contents Lists the major components of an equipment

Specified Explains manufacturers specifications

Actual Things that are actually observed are listed here.

INSTALLATION CHECKLIST This section of protocol determines whether or not a

piece of the equipment or system as a whole meets the manufacturer’s design specifications.

It is recorded as “yes” or “no”Any “no’s are then recorded as deviations or

deficiencies.Environmental requirementsSpecifically considers humidity,temperature of a

particular piece of the equipment.

OPERATIONAL QUALIFICATIONTest equipment List the necessary test instruments,before starting

the test,first the instrument is to be calibrated and maintained as such till the completion of the test.

Test procedureAlarm testingOperation testing

PERFORMANCE QUALIFICATION Test EquipmentList any test instrument necessary and must be

calibrated prior to use and till the process completes.This is the final phase of the validation process.

Examples of Equipment validation Validation of autoclave Validation of ethylene oxide sterilisation systemValidation of radiation sterilisation methodValidation of filtersValidation of dissolution apparatus

Dissolution apparatus

INSTALLATION QUALIFICATION• Following points are to be considered. 1.Preventive maintenance of Dissolution Apparatus.

2.Utilities3.Environmental conditions:

As per the USP standards, “The dissolution Apparatus should be kept in an environment that do not provide additional motion/agitation/vibration to the rotating element of the apparatus.”

Operational Qualification:• It is also known as system suitability test• Performed using USP Calibrator tablets:

USP Prednisolone Tablets (disintegrating type)USP Salicylic acid Tablets (non-disintegrating type)

• Test is considered successful if the percent of drug released within 30 min. falls within the pre-established range.

• This test must be conducted for each of the vessels contained within a dissolution apparatus.

Some additional tests:

As per the guidelines of Validation for Dissolution test Apparatus,

• It is mandatory to perform 1.Temperature Distribution Study &2.Rotation Speed Study

VALIDATION OF STERILISATION PROCESS1.Installation includesSite specification/utilitiesApproval documentationChange/spare partsVendor specification sheetsDrawing verificationMechanical equipment specificationBill of materialsFactory performance tests

• Preventive maintenance program• Standard operating procedures• Control system documentation• Instrument calibration• Weld inspection/surface roughness

documentation• Operation and maintenance manuals

Operational qualification includes Power loss recovery testSource code reviewFilter sterilisationLeak testSaturated steam test

FUTURE OF EQUIPMENT VALIDATION

PAT(Process analytical technology) will add new dimensions to the validation in future.

REFERNCES• Pharmaceutical quality assurance by Manohar

A.Potdar,Nirali Prakashan.Pg no.8.1-8.22.CBS publishers.

• Equipments and its validation by Nash.Pg no.315-319.

• http:/pharmatech.com• http:/ravenlabs.com

THANK YOU