This document discusses validation of equipment used in pharmaceutical manufacturing. It defines validation and its objectives, which include improving reliability and safety. The main parts of validation are described as qualification including design, installation, operational, and performance qualification. Common equipment that undergo validation are listed, such as dissolution apparatus, autoclaves, and sterilization equipment. The roles of protocols, procedures, calibration, and regulatory agencies like the FDA in the validation process are also summarized.

1. VALIDATION OF
EQUIPMENTS
Presented by
N.Lakshmi Priya
Dept. of
Pharmaceutics
M.Pharmacy 1st
Year

2. CONTENTS
Definiton
Objectives
Parts of equipment validation
Assembling of protocol
Equipments that are validated
References

3. 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

4. • 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

5. Parts of validation/Qualification

6. Principle
Equipment must be
designed
constructed
adapted
 maintained
to perform the operations which are to be carried out.

7. 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

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

9. QUALIFICATION POLICY FOR EQUIPMENTS
TO BE VALIDATED
Instruments used in production and quality control.
New systems and equipment
Qualification done in accordance with
predetermined and approved qualification protocols.
The results have to be recorded and reflected in
qualification reports.

10. 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 equipment
Environment
Functional and performance specifications.

11. 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

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

13. OPERATIONAL QUALIFICATION
- demonstrates that an instrument will function
according to its operational specification in the
selected environment.
DOCUMENTED RECORDS
Training of operators provided-training records
Systems 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.

14. 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.

15. CONTENT OF EQUIPMENT VALIDATION
1.Application S.O.P’s
2.Utilisation list
3.Process description
4.Test instrument utilised
5.Test instrument calibration
6.critical parameters
7.Test function
8.Test function summaries

16. • The Validation process is regulated by the
guidelines & restrictions set forth by the
FDA.
• CFR: Code of Federal Regulation
created 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

17. Assembling of a validation protocol
Documented formats or protocols
Helps in systematising the study of equipment
validation.
Different formats have been specified for
designing protocols and carrying out operational
qualification.

18. PURPOSE
This procedure details the assembly and 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 and
procedures.
Protocol describes “how” the system is to be
validated while forms document these procedures
and provide a written record of the processes.

19. 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

20. Installation qualification includes
Inspection checklist
Installation checklist
1.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.

21. 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 requirements
Specifically considers humidity,temperature of a
particular piece of the equipment.

22. OPERATIONAL QUALIFICATION
Test 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 procedure
Alarm testing
Operation testing

23. PERFORMANCE QUALIFICATION
Test Equipment
List 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.

24. Examples of Equipment validation
Validation of autoclave
Validation of ethylene oxide sterilisation system
Validation of radiation sterilisation method
Validation of filters
Validation of dissolution apparatus

25. Dissolution apparatus

26. INSTALLATION QUALIFICATION
• Following points are to be considered.
1.Preventive maintenance of Dissolution Apparatus.
2.Utilities
3.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.”

27. 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.

28. 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

29. VALIDATION OF STERILISATION PROCESS
1.Installation includes
Site specification/utilities
Approval documentation
Change/spare parts
Vendor specification sheets
Drawing verification
Mechanical equipment specification
Bill of materials
Factory performance tests

30. • Preventive maintenance program
• Standard operating procedures
• Control system documentation
• Instrument calibration
• Weld inspection/surface roughness
documentation
• Operation and maintenance manuals

31. Operational qualification includes
Power loss recovery test
Source code review
Filter sterilisation
Leak test
Saturated steam test

33. FUTURE OF EQUIPMENT VALIDATION
PAT(Process analytical technology) will add new
dimensions to the validation in future.

34. 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

35. THANK YOU