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.
