Standard operating procedure of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of all equipment and instruments used in different departments.
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1.0 OBJECTIVE:
To
lay down the procedure for cleaning installation, operational and performance
qualification of equipment/ instruments.
2.0 SCOPE:
This
SOP shall be applicable for installation, operational and performance
qualification of utility and process equipment/ instruments.
3.0 RESPONSIBILITY:
3.1
Head of Engineering
Department.
4.0 ACCOUNTABILITY:
4.1
Head of Quality
Assurance Department.
4.2
Head of Production
Department.
5.0 PROCEDURE:
5.1
Ensure the ID
number is assigned and affixed to the equipment after receipt.
5.2
For the
equipment / Installation Qualification (IQ), Operational Qualification (OQ)
shall be performed and Performance Qualification (PQ) shall be performed
wherever required. PQ can be done individually or as a part of process
validation.
5.3
INSTALLATION
QUALIFICATION (IQ): The installation qualification
shall be performed as per the approved protocol and the protocol shall be
prepared by engineering department. A typical installation qualification
protocol for equipment shall cover various headings as described below:
5.3.1 Equipment
description and identification: This section provides
the description, name and address of the manufacture/supplier, equipment model
number, equipment serial number, purchase order number and date, location of
the equipment, date received and date installed.
5.3.2 Equipment
master flies: This section provides the list of
drawings, reference documents (instruction manual, maintenance manual), test
certificates and spares. The protocol number and page number shall be written
on the drawings as well as test certificates and shall be verified by
engineering department.
5.3.3 Major
components: This section identifies and provides
the specifications of the major components. The specifications (e.g. MOC,
surface finish, joints, etc.) shall be checked against the actual and signed.
The base for checking the specification may be physical
inspection/measurement/calculations, nameplate details, and test certificates
given by manufacturer or equipment manual. In case any deviation is observed
shall be noted down under the heading ‘Comment’.
5.3.4
Material
of construction (MOC): This section identifies and
provides the material of construction of the equipment / part of the Equipment.
The base for checking the MOC is test certificate provided by the manufacturer
/ supplier or in-house testing by7 using moly kit.
5.3.5
Safety
features and alarms: This section identifies and provides
the list of safety interlocks and alarms for [roper installation.
5.3.6
Utilities:
This section identifies and provides the details of utilities for proper
installation.
5.3.7
Standard
operating procedures (SOPs) / preventive maintenance procedure:
This section identifies and list all the standard operating procedures (SOPs)
and preventive maintenance procedures associated with the equipment or
instrument.
5.3.8
Installation
verification: This section provides a summarized
verification for the equipment / part of equipment / instruments.
5.3.9
Acceptance
criteria: This section verifies that the installation
parameters of the equipment meet the acceptance criteria.
5.4
OPERATIONAL
QUALIFICATION (OQ): The operational qualification
shall performance as per the approved protocol and the protocol shall be
prepared jointly by engineering and user department.
A
typical operation qualification protocol for equipment shall cover headings as
described below.
5.4.1
Instruments
calibration: This section lists out all the critical
and non-critical instruments for calibration ensuring tractability of
certificate with authentic standards. The calibration certificates for the same
shall be attached with the qualification document.
5.4.2
Control
panel testing: This section verifies the sequential
menu operation along with all the keys/ components/controls on the control
panel functions as designated. The method of testing and acceptance criteria to
check each key/ component/control shall be provided.
5.4.3
Safety
features testing: This section verifies that the safety
interlocks and alarms function, when the required conditions are simulated. The
testing for safety features shall be carried out for three times.
5.4.4
Operational
testing: Operational parameters of the equipment / part of
the equipment with specified acceptance criteria shall be verified.
5.4.5
Verification
of standard operating procedures (SOPs)/ preventive maintenance procedures:
This section verifies the SOPs / preventive maintenance procedures for adequacy
and completeness.
5.4.6
Acceptance
criteria: This section verifies that the operational
parameters of the equipment meet the acceptance criteria.
5.5
PERFORMANCE
QUALIFICATION (PQ):
5.5.1
Once it has been
established that the operational qualification is satisfactory, Performance
Qualification shall be carried out jointly by user and QA.
5.5.2
Performance
qualification shall be performed along with process validation for process
equipment.
5.5.3
The performance
qualification will be based upon the function of the equipment / system
installed.
5.5.4
Required testing
shall be performed to determine the effectiveness of the equipment related to
the process.
5.5.5
Process
validation shall be carried out for three consecutive batches as per the approved
protocol. After review of process validation report, it shall be approved by
head of QA & QC. Based on summary and conclusion of the process validation
report, the performance qualification of the process equipment shall be
prepared. Performance qualification report shall include the following.
Objective, scope, responsibility, list of process equipments involved in the
process with identification number. Summary of process qualification of process
equipment such as RMG, planetary mixer, FBD, Blender, compression machine,
strip packing machine, blister packing machine and container pack machine shall
be made separately for specific product combined with PQ.
5.6
OTHER
EQUIRMENT FOR QUALIFICATION CONTROL:
5.6.1
Each equipment
qualification protocol shall have header indicating company name, equipment
name, and equipment number, type of protocol, page number and protocol number.
5.6.2
In case of
identical equipment qualification, protocol shall have header indicating
company name, equipment name, equipment number, type of protocol, page number,
protocol number and report number.
5.6.3
In case the
qualification protocols are given by the supplier, same shall be reviewed and
approved.
5.6.4
Evaluation for
the requalification of the equipment shall be carried out in case of any major
modification or change in the location.
5.6.5
Page numbering
system for validation / qualification documentation:
In the 1st page the
page number shall be “page 1 of Total number of pages”. For
example in this case it will be
“page 1 of 8”. The subsequent pages will be given the
page numbers as given in this SOP.
5.6.6
The 1st
page of the protocol shall be “Protocol Approval Page” wherein; the /signatures
of Head Engineering, Concerned Department Head, Sr. Vice President Technical
and Head QA shall be made.
5.6.7
The last page of
the protocol shall be “Report Certification Page” wherein; the /signatures of
Head Engineering, Concerned Department Head and Head QA shall be made.
5.6.8
Once the
protocol is approved, the specimens of the qualification report shall be taken
from the protocol for the actual execution.
5.6.9
For identical
equipment single protocol to be prepared and the individual reports shall be
executed. The numbering of the protocol and reports to be done as per SOP.
5.6.10
The deviations/
discrepancies observed during execution of qualification shall be investigated
and closed with proper justification before certification of the qualification
report.
5.6.11
Once the
equipment meets the specified acceptance criteria, executed equipment qualification
report shall be certified.
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