validation of equipment

8/12/2019 Validation of Equipment

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Miss Shraddha Kulkarni

Dept. of Pharmaceutics.

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Introduction:

Validation means rectification or confirmation.

It is the concept which establishes a documented program of specified & reliable

performance.

Definition:According to U.S.F.D.A.,

Validation is a documented progamme, which provides a high degree of

assurance that a specif ic process wil l consistently produce, a product meeting

its pre-determined specifications & quality attributes.

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Importance of Validation:

Every activity in business unit is done to get some benefits from that & naturally

Pharmaceutical Validation is no exception.

This means validation activity must give the industry some advantages/ some

benefits.

Four major advantages of validation:

1. Reduction of quali ty costs.

2. Process optimization.

3. Assurance of quality.

4. Safety.

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Validated &

controlled processproduce qualityproductsconsistently.

Increase inoperation safety.

Making the proces

effective, efficient,

perfect or useful a

minimum cost.

Preventive costs

Appraisal costs

Internal failure cost

External failure cost.

Reduction

of quali ty

cost

Process

optimization

Assurance of

quality

Safety

Advantages of Validation 5


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Scope of Validation:

Pharmaceutical validation is a vast area of work & it covers almost every aspect of

pceutical processing activities, e.g.,

Analyticaltest method.

Facilities

Instrument

calibration

Mfgoperation

Processutility

services

Productdesign

Rawmaterials

Cleaning

Packagingmaterials

Operators

Equipment

Scope

Of

Validation

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Validation of Equipments:

The basic component of pharma industry are the Equipments.

Therefore before validating a process that is carried out in a pharma industry,the issue of equipment validation becomes a prime importance.

Equipment validation is covered in several steps:

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1. User requirement specifications/ customer requirements(USR)

2. Design Qualification(DQ)

3. Installation Qualification(IQ)

4. Operational Qualification(OQ)

5. Performance Qualification(PQ)


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Principle

Equipment must be

located

designed

constructed

adapted

maintained

to suit the operations to be carried out.

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Equipment layout and designmust aim:

to min imize r isks of error.

to permit effective cleaning and maintenance.

To avoid:

1. cross-contamination, dust and dirt build-up.

2. any adverse effect on the quality of products.

Equipment must beinstalledto:

1. minimize risks of error.

2. minimize risks of contamination.


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Control laboratory equipment-

Equipment and instruments-

suitable for the tests to be performed.

Defective equipment-

Removed.

Labelled.

Washing, cleaning and drying-

Equipment used for washing and dryingnot the source of contamination.

Equipment design should promote easy cleaning.

Cleaning on scheduled basis, procedures and records.

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A) User requirement specif ications:

What are the expectations of the customer?

General requirements may be stated as follows:

1. size of the equipment

2. Speed of the equipment

3. Effectiveness of the equipment

4. Availability of the spares, change parts, prompt services at reasonable

cost.

5. Ease of operation, cleaning & maintenance.

6. Low dust & sound generation.

7. Lesser breakdowns.

8. Overall good construction & workmanship.


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2. Preparation of Design quali f ication-o User requirements should be considered when deciding on the specific

design of a system or equipment.

o A suitable supplier should be selected for the appropriate system or

equipment(approved vendor).

o For purchasing a standard equipment, it is not essential to prepare a D.Q.

document.

o

If the user asks for a specialized type of instrument, then he must submit hisRequirements in the form of a detailed design qualification document to the

supplier.

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3. I nstal lation quali f ication-

Verifies that the correct equipment has been received and installed as per

plan and protocol. Also that it is complete and undamaged (parts, services,

controls, gauges and other components).

Verifies that equipment has been properly installed and calibrated

including connections to utilities.

Documented records for the installation

I nstallation quali f ication report.

Include details, e.g.

The suppli er and manufacturer.

System or equipment name, model and ser ial number.

Date of installation.

Spare parts, relevant procedures and certi f icates.


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4. Operational quali f ication:

Systems and equipment should operate correctlyoperation verified as in

the qualification protocol.

Verifies that the equipment operates consistently within established limits

and tolerances over the defined operating ranges.

Challenges equipment functionally to verify compliance with

manufacturers specifications and end user defined requirements.

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Documented records -

(Operational quali f ication report)

Finalize and approve SOP (operation)

Training of operators providedtraining records.

Systems and equipment released for routine use after completion of

operational qualification, provided that:

All calibration, cleaning, maintenance, train ing and related tests and

results were found to be acceptable.


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5. Performance qualif ication:

Verifies that the equipment performs according to design specifications and

user defined requirements in a reliable and reproducible manner under

normal production conditions.

Verified in accordance with a performance qualification protocol.

Documented records

performance quali f ication report

Show satisfactory performance over a period of time, i.e. carried out long

enough to prove that the equipment is under control and turns out productof specified quality consistently.

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Assembling of a validation protocol:

Documented formats or protocols.

Helps in systematizing the study of equipment validation.

Different formats have been specified for designing protocols & carrying out IQ,

OQ & PQ.


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Purpose:

This procedure details the assembly & contents of the validation protocol for use

in validation testing.

Principle:

This protocol is generated by a validation specialist/engineer.

Protocol section contains required forms & procedures.

Procedure describes how the system is to be validated while

Forms document these procedures & provide a written record of the executed

qualification & validation processes.


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Testing procedures: Protocol packages are divided as

OQ PQIQ

SECTIONS OF A STANDARDISED PROTOCOL:

Table of contents

List of standard sections.

Unique testing procedures.

Approval page

Pre-approval section.

F inal approval section.

Description

Statement of purpose.Standard operating procedures.

(correct, complete & most cur rent versions)

Calibration.

Utilities.


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Purpose:This procedure describes the testing sections of an installation qualifications for a

piece of an equipment.

Principle:

It includes the sections of the standardized protocol.

A general description of the approaches & rationale to be used when writing the

Inspection & Installation sections of this protocol.

Procedure:

Inspection checklist.

Installation checklist.

A. Installation qualification- Equipment:


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II. Installationchecklist:

This section of protocol determines whether or not a piece of the equipment or

system as a whole meets the manufacturers design specifications.

It is recorded as yes or no.

Any no'sare then recorded as deviations or deficiencies.

Environmental requirements:

Specifically considers humidity, temperature, of a particular piece of the

equipment.


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B. Operational qualification:

Purpose:

It defines the procedure for the operational qualification of a piece of equipment.

Principle:

After installation, the verification of equipment capability is performed.

Includes:Alarm testing, control system testing, operation & maintenance procedures.

Test equipments:

List the necessary test instruments, before starting the test, first the instrument is

to be Calibrated & maintained as such till the completion of the test.

Test procedure:

e.g. alarm testing, Operation testing.


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C. Performance qualification:

Purpose:

To define testing requirements in a product/ process/ performance qualification/

validation protocol.

Principle:

This gives a general outline of the issues related to the process or plan.

Includes:

Background & reason for the plan.

Testing method used.

Predetermined general /specif ic acceptance cr iter ia.


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Test equipment:

List any test instrument necessary & must be calibrated prior to use & till the

process completes.

Procedure:

This is the final phase of the validation process.

Before PQ validation testing is implemented for all processes

Product specifications are established

& judged acceptable.

Testing procedures:

Design of the expt.

These procedures are tailored to challenge the exact process or product to be

validated using normal operating parameters in a SOP

Validation will demonstrate that by using these parameters the quality product

intended can be produced consistently.


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Worst case conditions:

A worst case challenge will encompass upper & lower process limits &

circumstances & will pose greatest chance of process or product failure when

compared to actual production conditions.

Microbiological challenges:

Controlled environment is necessary for the production of many pharmaceutical

products & sterile environments is essential for the manufacture of parenterals.

For a predetermined period of time test for microbial growth is performed under

certain challenge condition.


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Conclusion:

User requirement specifications play an important role in the design of an

equipment.In order to design a specialized instrument a design qualification document is to

be submitted by the customer to the supplier.

When an equipment passes all the norms that are specified in an I.Q., O.Q. &

P.Q. test, the equipment is said to be validated.


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References:

1. Pharmaceutical Quality Assurance

by Manohar A. Potdar.

Nirali Prakashan

Page no- 8.1 to 8.22

2. Equipment & Its Qualification

By Rutendo Kuwana

Technical Officer, WHO, Geneva.


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Thank you

validation of equipment

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