This document discusses various aspects of facility qualification including validation master plans, user requirement specifications, design qualifications, installation qualifications, operational qualifications, performance qualifications, and requalification. It emphasizes that qualification proves systems work correctly and as expected. Validation plans encompass all validation aspects for facilities and equipment. User requirements specify functional and operational needs. Design reviews verify design suitability. Installation and operational qualifications check that systems are installed and perform as intended. Performance qualifications demonstrate effective performance under routine conditions. Requalification occurs on a defined schedule. Change control reviews changes that could affect validation status. Comprehensive documentation is also needed.

1. FACILITY QUALIFICATION &
CONSIDERATION OF VARIOUS ASPECTS
Prepared By : Apoorva Bauskar
F.Y. M.Pharm QAT Sem II
Roll No : 517
Guided By : Dr S.P. Mahaparale

2. INTRODUCTON
 Qualification : It is defined as act of
proving that any system works
correctly & leads to expected results.
 To execute this, a plan is necessary.
 For single system suitable protocol.
 For whole facility Validation Master
Plan (VMP).
 Validation Master Plan : Plan that
encompasses all aspects of validation
& qualification.

3.  For every segment separate sub-
plans.
 For facility & equipment Facility
Equipment Qualification Plan

4.  Introduction : Firm validation policy &
general description.
 Organizational Structures :
Description of personnel responsibility
for all validation activities.
 Plant, process & product
description
 Specific Process Consideration :
Critical process.
 Lists of products, processes,
EQUIPMENT & FACILITY
MASTER PLAN

5.  Key Acceptance Criteria.
 Documentation : Protocols & reports.
 Required SOP’s
 Planning & Scheduling : Describe
estimated resources for staffing,
equipment & other specific
requirements
 Change Control.

6. USER REQUIREMENT
SPECIFICATION (URS)
 It is the most critical of the documents.
 It should define what the system
requires to do.
 Comprehensive.
 Reflects the intended functional use of
the system.
 Addresses the operational,
performance, regulatory, engineering,
EHS, & commercial requirements.

7.  Goal to document the needs of
manufacturing operations.
 It provides a clear & precise definition of
what user wants the system to do.
 Defines the functions to be carried out,
the data on which the system operate &
the operating environment.
 Also defines any non-functional
requirement constraints such as time &
cost & what deliverables are to be
supplied.
 Documents the purposes for which a
process, equipment, facilities, or
systems is required.

8.  Describes essential & desirable
requirements.
 Defines operating environment within
which the system operate.
 Prepared & approved by QA
representatives.
 It generates a document detailing all
GMP requirements as well as
Technical & Economic Documents.

9. CHARACTERISTICS OF URS
 Approved prior to purchase of
equipment.
 Subjected to formal change control.
 Relate to the best information
available from developments reports &
reviews.

10. CONTENTS OF URS
 Cover Sheet : Name, referencing with
number system, date & signature of
author, approvals with signature &
date of user, engineering & QA
personnel.
 Scope : Purpose or general intention
of URS, introduction of focused
system & project.
 Definitions : Abbreviations &
definitions.

11.  System Descriptions : Brief description
of system, system boundaries, details of
the product produced with the system,
importance & outlining of technical
aspects.
 Positioning Requirements : What
requirements the system has concerning
with location & interfaces to other
systems.
 System Specification : Descriptions of
all imp & critical specifications such as
critical process parameters, technical
parameters, safety & environmental
parameters & GMP relevant information.
 Regulatory Requirements : References
of all regulatory documents important for
implementing system.

12. DESIGN QUALIFICATIONS
(DQ)
 First step in the validation.
 The compliance of design with GMP is
demonstrated & documented.
 Documented verification that the
proposed design of equipment &
system is suitable for intended
purposes.
 It is also called as design review &
design assessment.

14. TYPES OF DESIGN
QUALIFICATIONS
 RISK ANALYSIS
 Helps to decide whether the aspect is
GMP-critical or not.
 Performed formal or more informal
way.
 Fault tree analysis (FTA) is a type of
risk analysis.
 It is used in computer validation.
 It is complex form of risk analysis.

15.  FMEA ( Failure Mode & Effect
Analysis)
 Quantitative risk analysis for complex
systems.
 It involves which are as follows
a) Is the system critical ?- It must be
determined whether the system is
critical or not.
b) Potential failure must be found.
c) Cause & effect must be documented.
d) Assessment of GMP Risk.
e) Risk priority number.
f) Take Measures.
g) Documentation.

16.  HACCP (Hazard Analysis of Critical
Control Points)
 It is mostly applied in the food
industry.
 Goal to reduce the risk of
contamination of products & to reduce
the effort.
 It defines critical control points
(CCP’s) in different grades usually
three grades.
 HACCP protocols are worked out &
results are documented in reports.

17.  Steps in HACCP are as follows :
i. Definition of CCP’s & their limits.
ii. Implementation of change control
system
iii. Execution of corrective actions.
iv. Regular Audits of the concepts.
v. Approval of HACCP Protocols using
appropriate procedures.

18. INSTALLATION
QUALIFICATIONS (IQ)
 It is the documented verification that
the systems as installed or modified
comply with approved design &
manufacturers recommendations.
 Systems should be correctly installed
in accordance with an installation plan
& installation qualification protocol.
 Requirements for calibrations,
maintenance & cleaning should be
drawn up during installation.

19.  There should be documented records
for installation to indicate
satisfactoriness of installation.
 It includes
 Installation of equipment, piping,
services & instrumentation checked to
current engineering drawings &
specifications.
 Working instructions & maintenance
requirements.
 Calibration requirements.
 Description of equipment.

20.  Principle of operation.
 Facility functional specifications.
 Design Requirements.

22. OPERATIONAL
QUALIFICATIONS
 It is the documented verification that
the system or sub-systems performs
as intended through all anticipated
operating ranges.
 Range of tests are carried out to
demonstrate the integrity &
functionality of the system.
 It can be carried out by a supplier or
by laboratory personnel.
 It must be performed using an agreed
protocol.

23.  Critical operating parameters are
identified.
 It includes verification of operation of
all system requirements, parts,
services, controls, gauges & other
components.
 SOP’s for operation are finalized &
approved.
 Training of operators for the systems
provided
 Training records maintained.
 After completion of OQ, systems
released for routine use.

24. APPROACH FOR OQ
Perform OQ
Approve OQ Protocol
Develop OQ Protocol

25. Approve OQ report by
QA, production &
technical departments
Work out OQ Report

26. TYPICAL TESTS IN OQ
 Alarm tests.
 Behavior of system after energy
breakdown.
 Accuracy of filling lines.
 Transportation speed in sterilization
tunnel.
 Temperature distribution in an
autoclave.
 Performance of Washing Machine.
 Accuracy of Weighing System.

28. PERFORMANCE
QUALIFICATION (PQ)
 It is the documented verification that
the system as connected together can
perform effectively & reproducibly
based on approved process method &
product specification.
 It is performed to demonstrate that the
facility performs as per routine
operational conditions.
 It is the phase in which the technical
system is tested over long period of
time.

29. REQUALIFICATION
 It is done in accordance with defined
schedule.
 Frequency of re-qualification can be
determined by factors such as analysis
of results relating to calibration,
verification & maintenance.
 Periodic.
 There should be requalification after
changes.
 Requalification after change is
considered as the part of change control
procedure.

30. DOCUMENTATION
 To quickly locate any given document,
it is mandatory to have implemented
an appropriate document system.
 All companies should test the
reliability of their documentation
system using internal audits.

31. EXAMPLE OF DOCUMENTED
STRUCTURE
Conceptual Design
 URS.
 Authority application.
 Qualification Protocol.
 Calculations.
 Design Documents.
 Project Documents.

32. System Description
 Technical Drawings.
 Parts list.
 Software.
 Description.
Production
 Foundation Plan.
 Assembly plan.
 Mounting instruction.

33. Operation Training
 List of spare parts.
 Working Instructions.
 Maintenance.
 Changes.
 Legal Tests.

34. CHANGE CONTROL
 It is a formal system by which qualifies
representatives of appropriate
discipline review proposed or actual
changes that might affect the validated
status of the system.
 Life-time monitoring approach.

35. ASPECTS OF CHANGE
CONTROL
 Workable documentation system.
 Defined responsibilities & job
descriptions.
 Defined review procedure.
 Well trained staff.

36. REFERENCES
 Dr Sohan S. Chitlange, Dr Pravin D.
Chaudhari, Mr. Ajinath E. Shirsat, Dr
Jaiprakash N. Sangshetti,
Pharmaceutical Validation, Page No
3.1-3.12
 Pharmaceutical Process Validation by
Robert A. Nash, Alfred H. Wachter, 3rd
Edition, Page No 443-465

37. THANK YOU