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Validation

The document discusses the concepts of validation and qualification in pharmaceutical processes, emphasizing their importance in ensuring quality products. It outlines the advantages of validation, the Validation Master Plan (VMP), and the four stages of qualification: Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification. Each stage is detailed with its purpose and requirements to ensure that systems and equipment operate correctly and consistently meet expected results.

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13 views10 pages

Validation

The document discusses the concepts of validation and qualification in pharmaceutical processes, emphasizing their importance in ensuring quality products. It outlines the advantages of validation, the Validation Master Plan (VMP), and the four stages of qualification: Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification. Each stage is detailed with its purpose and requirements to ensure that systems and equipment operate correctly and consistently meet expected results.

Uploaded by

mname0930
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPTX, PDF, TXT or read online on Scribd
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HALDIA INSTITUTE OF PHARMACY

TOPIC: VALIDATION AND QUALIFICATION

PRESENTED BY – SUBHANKAR MAITY

(M.PHARM PHARMACEUTICAL ANALYSIS)


CONTENTS

* VALIDATION

* QUALIFICATION

* ADVANTAGES OF VALIDATION

* VALIDATION MASTER PLAN (VMP)

* STAGES OF QUALIFICATION

* DESIGN QUALIFICATION

* INSTALLATION QUALIFICATION

* OPERATIONAL QUALIFICATION

* PERFORMANCE QUALIFICATION
VALIDATION AND QUALIFICATION

Validation- Validation is the action of proving that any procedure, process, method, or activity
leads to the expected results and produce a quality product.

Qualification – Qualification is the process of providing that equipment or system are properly
installed, work correctly, and actually lead to the expected results.

* Validation and qualification are essential components of the same concept

* Qualification is part of validation

NEED OF VALIDATION

* To obtain consistent, reliable, and accurate data

* Act as a proof of decision making

* To get assurance of quality product


Advantages of validation

* Assure every lot of each product meet all quality requirements

* It is capable of achieving the intended results

* Conformation to GMP requirements

* To identify root cause of problems

* Makes process better understand

* Reduces the risk of problems

* Assures smooth running of the process

* Maintains a company’s public image

* Documents that the final product has followed reliable manufacturing process
VALIDATION MASTER PLAN [VMP]

VMP is a documents that is a summary of the planned validation activities,


It lists those activities , which will be generated and defines staff responsibilities.

It provides information
* on the manufacturer’s validation work programme
* It should reflect the key elements of the validation programme

Purpose of VMP :
* The VMP should present on overview of the entire validation operation, it’s organisational
structure, it’s content and planning.
* TO understand the approach of validation and also help to understand the necessity
for the programme
QUALIFICATION

There are four stages of qualification

* Design qualification (DQ)

* Installation qualification (IQ)

* Operational qualification (OQ)

* Performance qualification (PQ)

* All SOPs for operation, maintenance and calibration should be prepared


during qualification

* Training should be provided to operators and training record should be


maintained
DESIGN QUALIFICATION (DQ)

• It is a documented collection of activities that defines the functional


and operational specifications of the instrument/ equipment,on the
intended purpose of the equipment.

* Contains
(1)Description of equipment
(2) References: (a) specification
(b) order number
(3) Machine specification
(4) Approvals/ authorisation
(5) Manuals
(6) Certifications
INSTALLATION QUALIFICATION (IQ)

Installation qualification should provide documented evidence that the installation was
completed, satisfactory and operate in accordance with established specifications.

Installation qualification verified-


* The purchase specifications
* Drawing, manuals
* Spare parts lists
* Vendor details
OPERATIONAL QUALIFICATION (OQ)

Operational qualification is a quality assurance process that verify equipment, system


Or software operate correctly.

* Ensure the equipment operates as expected


* Produce reliable results
* Meets acceptance criteria
* Identify equipment features that impact final product quality
* SOPs for use, maintenance, calibration, cleaning of the plant,
schedules for maintenance and calibration are developed.
PERFORMANCE QUALIFICATION (PQ)

Documented collection of activities necessary to demonstrate that an


equipment/system consistently perform according to the specifications
defined by the user, and is appropriate for the intended use .

* It is the final step of validation process.


* Quality the entire plant with respect to the production process.
* Ensure that the system consistently produce the desired output.
* All necessary SOPs should be approved.

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