Preparation, Review
and Approval of Equipment, Utilities Qualification document

 

1.0  OBJECTIVE

1.1    
To lay down
the procedure for the preparation, review and approval of Equipment, Utilities
qualification document.

 

2.0  SCOPE

2.1    
This procedure
is applicable to all qualification related to testing, manufacturing, packaging
and distribution of drug products of Abc pharma Limited.

 

3.0  RESPONSIBILITY

3.1    
Validation
team shall prepare and execute the qualification document.

3.2    
Quality
Assurance, Maintenance and functional department head or designee shall review
and approval of the document.

3.3    
Head
Quality Assurance shall be responsible for the implementation / compliance of
this SOP.

4.0  DEFINITION
(S)

 

4.1    
Qualification:

        Qualification is the
planning, carrying out and recording of tests on equipment and systems, which
form part of the validated process, to demonstrate that it will perform as
intended.

4.2    
Design qualification (DQ):

The documented verification
that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.

4.3    
Installation qualification (IQ):

       The documented verification that the
facilities, systems and equipment, as installed or modified, comply with the
approved design and manufacturer’s recommendations.

4.4    
Operational qualification (OQ):

       The documented verification that the
facilities, system and equipment, as installed or modified, perform as intended
throughout the anticipated operating ranges. 

4.5    
Performance
qualification (PQ):

The documented verification that the facilities,
system and equipment, as connected together, can perform effectively and
reproducibly, based on the approved process method and product specification.

 

 

5.0  PROCEDURE

5.1    
All manufacturing
equipment, laboratory instrument and supporting utilities shall be considered
for qualification.

5.2    
After
successful completion of qualification exercise, the Equipment / instrument /
Utilities shall be certified for its intended use.  

5.3    
Qualification
activities include,

5.3.1      
Design
Qualification (DQ)

5.3.2      
Factory
Acceptance Test (FAT)

5.3.3      
Site
Acceptance Test (SAT)

5.3.4      
Installation Qualification
(IQ)

5.3.5      
Operational
Qualification  (OQ)

5.3.6      
Performance
Qualification  (PQ)

5.3.7      
Re-qualification 

Note: For standard make/
model equipments and those which are exactly similar, earlier approved protocol
reference is taken and report is printed in which data is captured. Such
protocols with single approval page shall bear the earlier protocol reference
number, which is approved by Quality Assurance.

5.4     User requirement specification (URS)

5.4.1      
A User
requirement specification specifies the basic requirements for the individual
aspects of facility, item of equipment, utility and systems in terms of
function, capacity, output, operating parameters, control system and other
cGMP/ GLP requirements. A detailed user requirement specification shall not be
prepared for commercially available equipment/ instrument/system.

5.4.2      
User
requirement specification shall be prepared by the Maintenance dept or user
department and shall be reviewed by head of designee and approved by Head
Quality Assurance. 

5.4.3      
User shall
forward the URS to purchase department to initiate the procurement.

5.4.4       Purchase shall discuss the
detailed URS with respective vendors and based on the technical discussion, the
vendor shall be finalized. Once the vendor is identified, the URS acceptance
shall be taken from the vendor. URS acceptance by the vendor need not be taken
for the machines / equipments / instruments / analytical instruments, which are
of standard make and repeated orders.

5.4.5       Purchase department shall
generate purchase order and submit a copy of approved URS to Vendor / supplier
for procurement / fabrications.     

 

5.5     Design Qualification (DQ)

5.5.1 Design
Qualification shall be prepared for the new projects or any
modification/renovation or expansion in the existing facility and for
customized equipment / system.

5.5.2      
The design
qualification shall consist of following:

5.5.3      
Objective
-This section describes about the intend of design qualification.

5.5.4   Scope- This
section describes the extent to which design qualification is applicable.

5.5.5      
Responsibility

5.5.6      
Equipment Identification

5.5.7      
Acceptance
Criteria

5.5.8      
System Description

5.5.9      Basis of design-This section describes the basis of
design like multi purpose multi equipment facility or dedicated facility, type
of dosage from / product to be manufactured, capacity / out put, Temp , % RH requirements, civil design basis,
electrical design basis / loads, utilities design basis, equipment design basis
requirements etc.

5.5.10   Machine Specification

5.5.11   Supporting Utilities

5.5.12   Material of Construction

5.5.13   Safety Features

5.5.14   Abbreviations

5.5.15   Supporting documents

5.5.16   Conclusion and summary

 

5.6     Factory Acceptance Test (FAT):

5.6.1  FAT shall be
carried out to ensure that all the design criteria and process requirements as
laid down in the URS / Purchase order has been addressed by the vendor.

5.6.2       
Factory
Acceptance Test shall be conducted at manufacturer’s/ supplier’s site by
inspection team comprising of representative from User and Projects / Maintenance
department.

5.6.3       
Factory
acceptance test shall be performed for custom-built equipment / system /
instrument(s) only.

 

5.6.4       
The
inspection team shall finally give the clearance for dispatch of the Equipment
/ system / instrument. 

 

5.7     Site Acceptance Test (SAT):

Site Acceptance Test shall be carried out by
Validation team / Maintenance / Project / User
at users end to ensure that all the arrangements are made as per general
arrangement GA / P&ID drawing, manufacturer’s / supplier’s recommendation,
which includes identification of utilities, foundation for equipment
installation and electrical arrangements.

5.8     Installation Qualification (IQ):

5.8.1      
Installation
Qualification shall be carried out to ensure that all aspects of the
facility/utility/equipment/instrument that can affect product quality adhere to
User Requirement Specification / Manufacturer’s recommendations.

5.8.2       Installation Qualification activity shall be
categorized into two phases. IQ shall include general and functional verification
of any utility/equipment/

5.8.3       General verification of IQ includes

5.8.3.1    
Identification
of execution team members:

Identify the execution team members from
Quality Assurance, user department and any other related departments as per the
requirement.   

5.8.3.2    
Verification
of Drawing(s), Manual(s) and related document(s):

List out the drawings, manuals received.

5.8.3.3    
Installation
Checklist

Verify the proper installation of the
equipment / system as per user requirement specification / manufacturer’s
recommendation.

5.8.3.4    
Verification
of Material of construction

Check the material of construction of contact
/ non-contact parts of the equipment / system and check the manufacturer’s
certificate thereof. List out and verify the contact / non –contact parts.

5.8.3.5    
Verification
of Utilities

Check the utilities connected to the equipment / system as per
requirement and verify the same at the user point.

5.8.3.6    
Major
component verification

Identify and list out major components and check whether they are
installed as per design specification / user requirement specification /
Manufacturer’s recommendation.

5.8.4       General Verification of OQ includes,

5.8.4.1    
Instrument
calibration

5.8.4.2    
Identify and
classify the measuring instrument as critical / non critical and calibrate as
per the procedure. .

5.8.4.3    
Verification
of procedures

5.8.4.3.1       
Verify the
procedure in connection with the operation of the equipment / system,
preventive maintenance and record the details in General Verification format-
Verification of Procedures.

                                                            Note:
i) Reports of IQ/OQ & PQ bears only the important content pages like
report identity page, table of content, summary and conclusion and
certification pages.

                                                            ii) All other applicable common formats
are attached at time of execution of the qualification document.

5.8.5       Functional Verification of OQ includes,

5.8.5.1    
Control Panel
Testing

5.8.5.1.1  Check the
electrical /MMI or HMI/pneumatic switches function testing provided on control
panel. For custom built equipments, perform the control panel testing once.
Control panel testing of standard equipments shall be performed as part of
verification of Operating Instructions / Standard Operating Procedures.

5.8.5.2    
Safety
Feature Testing

5.8.5.2.1       
Check all the
safety features (interlocks) in connection with the equipment / system. Repeat
the exercise for two more times.

5.8.5.3    
Operational
Testing

5.8.5.3.1       
Verify the
operating parameters of the equipment /instrument / system for the efficiency
of the equipment and its components.

5.8.5.4    
Performance
of Motor / Blower.

5.8.5.5   Check and
record the other critical operating parameters in the Functional Verification
and record the detail in report.

5.8.5.6 Ensure that
the calibration details of standard instruments used for checking the operating
parameters are within the validity and record the calibration details.   

5.9     Performance Qualification (PQ):

5.9.1    Performance
qualification shall be carried out for all manufacturing equipment/ laboratory
instruments and supporting utilities.

5.9.2  Performance
qualification shall be carried out by conducting Trial run using placebo or
product.

5.9.3 Performance
qualification can also be performed along with operational qualification where
found appropriate and with proper
justification.

5.9.4   Performance
Qualification protocol shall be prepared based on the type of the equipment /
test to be conducted or challenges to be performed.

5.10 The performer shall carry out all the qualification
activities mentioned in the protocol    
and sign immediately after completion of each activity in the checked
by/date column provided for the same.

5.11 The reviewer shall counter check and certify that the
performer has carried out the validation activities as per the test procedure
of the protocol and sign in the Verified by/date column provided for the same.

5.12 The approved validation documents shall be handed over
to Quality Assurance .

5.13 Re-qualification: 

5.13.1   
Re-qualification shall be triggered, if there is change in location
from one area to another area, major modification in the equipment, which has a
direct impact on the product quality. The same shall be captured through change
control. 

5.13.2   
Re-qualification shall be carried out by preparing the supplementary
qualification protocol based on the change control committee recommendation.

5.13.3   
The Supplementary validation shall be carried out by using the related
general verification and functional verification format depend upon the type of
the change/modification made therein.

5.13.4  After completion of validation / qualification activity, final approval
/ certification shall be taken before put into operation.   

5.13.5   
The equipments like Dry Heat Sterilizer, Autoclave, HVAC system, LAF
/RLAF workstation etc. shall be subjected to revalidation in accordance with
the defined schedule.     

5.13.6   
If there is no changes or modification in the equipment / system,
periodic assessment shall be carried out to ensure that it is in validated
state.  The frequency shall be once in
two years.

5.13.7   
Periodic assessment study shall consist of verification of details like
calibration records, preventive maintenance record, history card of the
equipment / system, Physical status of the equipment / system, empty run of the
equipment / system. The same shall be recorded in the supplement qualification
protocol.

5.13.8   
 In case of laboratory
instruments or any other instrument / equipment, validation documents provided
by the vendor, the same shall be considered as validation / qualification
document.

5.14 Utility Qualification:

5.14.1    Water system

5.14.1.1 The qualification includes water generation, storage
and distribution system.

5.14.1.2 Following shall be covered under water system
qualification

5.14.1.3 Design Qualification :

5.14.1.3.1    Acceptance criteria

5.14.1.3.2    Basis of Design

5.14.1.3.3    System Description and
technical specification

5.14.1.3.4    Critical safety features

5.14.1.3.5    Physical particulars
checklist.

5.14.1.4 Installation Qualification:

5.14.1.4.1   
Water system
description

5.14.1.4.2   
Major component
verification

5.14.1.4.3   
Utilities
verification

5.14.1.4.4   
Hydro Test

5.14.1.4.5   
Verification
of Supporting documents

5.14.1.5  Operational
Qualification:

5.14.1.5.1    Operational
testing

5.14.1.5.2    Calibration
of critical Instruments

5.14.1.5.3    Drainability
test repot

5.14.1.5.4    Dead
leg measurement 

5.14.1.5.5 Operation/Cleaning/Sanitization/Passivationprocedure.            

5.14.1.6 Performance
Qualification:

5.14.1.6.1    To
ensure that the water systems including Raw water system, RO water System, Purified
water system and WFI system, meet the In-House and Pharmacopoeial
specifications of IP, BP USP.

5.14.1.6.2    To
confirm the appropriateness of critical parameters of the water system.

5.14.1.6.3    To
perform water drain time study.

5.14.1.6.4    To
perform Hold time study for purified water & WFI in the water storage tank.

5.14.1.6.5    To
establish reliability of water system.

5.14.1.6.6    To
establish the efficacy of sanitization procedures.

5.14.1.6.7   
To validate the system and check its
performance.

5.14.2   
HVAC system:

5.14.2.1 The Air handling system (AHU) catering to warehouse
area, process area and quality control lab shall be considered for
qualification. Following shall be covered under HVAC system qualification

5.14.2.2 Design Qualification shall
cover followings:

5.14.2.2.1    Acceptance
criteria

5.14.2.2.2    Design
specification

5.14.2.2.3    Machine
description and technical specification of all

         components.

5.14.2.2.4    Details
of utilities

5.14.2.2.5    Material
of construction of all components.

5.14.2.2.6    Safety
features and alarms.

5.14.2.3 Installation Qualification
shall cover followings:

5.14.2.3.1    HVAC
system description

5.14.2.3.2    Major
component verification

5.14.2.3.3    Utilities
verification

5.14.2.3.4   
 Verification of supporting
documents.

5.14.2.4
Operational Qualification
shall cover followings:

5.14.2.4.1   
Operational testing

5.14.2.4.2   
 Calibration of critical
Instruments

5.14.2.4.3      Filter Integrity test report

5.14.2.4.4   
  Differential Pressure across
the filter

5.14.2.4.5   
  Air velocity and air changes

5.14.2.4.6   
  HEPA filter insulation
integrity

5.14.2.4.7   
  Verification of safety feature
and interlocks

5.14.2.5
Performance Qualification
shall covers followings:

5.14.2.5.1    Room
Temperature and Humidity

5.14.2.5.2    Room
Pressure Differential

5.14.2.5.3    Air
Flow Pattern

5.14.2.5.4   
Viable and Non viable Particle count

5.14.2.5.5    HEPA
Filter integrity and recovery rate

5.14.2.5.6    Air
Flow velocities and No. of air changes.  

5.14.3   
Compressed Air Qualification:

5.14.3.1 Compressed Air system shall
be qualified where the compressed air directly comes in contact with the
products.

5.14.3.2 Design
Qualification shall covers followings:

5.14.3.2.1  Acceptance
criteria

5.14.3.2.2  Basis of design

5.14.3.2.3  System
Description and technical specification

5.14.3.2.4  Critical safety features.

5.14.3.2.5  Physical
particular checklist.

5.14.3.3 Installation
Qualification shall covers followings:

5.14.3.3.1    Compressed
Air system description

5.14.3.3.2     Major component verification

5.14.3.3.3     Utilities verification

5.14.3.3.4     Verification supporting Documents.

5.14.3.4
Operational Qualification
shall covers followings:

5.14.3.4.1     Operational testing 

5.14.3.4.2     Calibration of critical instrument

5.14.3.4.3     Filter integrity test report

5.14.3.4.4     Verification of safety features and interlock

5.14.3.4.5     Verification of standard operating procedure
and   

  preventive maintenance.

5.14.3.5
Performance Qualification
shall covers followings:

5.14.3.5.1    Airborne
Particle count.

5.14.3.5.2    Moisture
Content. 

5.14.3.5.3    Hydrocarbons
as Oil Mist.

5.14.3.5.4    Microbial
load.

                                          Note:
The
standard equipments / instruments like Vernier calipers, Disintegration tester,
Friabilator, Hardness tester, Weighing balance, Moisture analyzer, Leak test
apparatus etc shall be calibrated before putting into use.

6.0  REFERENCES

SOP on Preparation review and approval of Validation
Master Plan.

 

7.0  ABBREVATION
(S)

 

 

8.0  FLOW CHART
(S)

         Not
applicable

9.0  ANNEXURE (S)

   NA

10.0   
CHANGE HISTORY

                                   

CHANGE HISTORY DETAILS
Supersedes	S. No.	Changes made