-
Cipla
Patalganga
STANDARD OPERATING PROCEDURE
No.: MT95
EQUIPMENT QUALIFICATION
Date of Issue
盛年不重来，一日难再晨。及时宜自勉，岁月不待人。
PURPOSE:
To provide a
formal methodology to be followed during
qualification of equipment.
SCOPE:
Applicable
to
qualification
of
new
equipment,
re-qualification
of
equipment,
which
has
undergone major
modification, relocation of equipment and Periodic
Qualification as per
schedule in Pharma
manufacturing department.
RESPONSIBILITY:
Production,
Engineering, Safety, Quality Control and Quality
Assurance staff.
DEFINITION:
Qualification:
Documented
verification that the environment and equipment
are
appropriate for the designated
function.
User Requirement
Specification (URS):
A
Requirement specification that
describes
what the equipment or system
is suppose to do, thus containing at least set of
criteria
or conditions that have to be
met.
卑微如蝼蚁、坚强似大象
Cipla
Patalganga
STANDARD OPERATING PROCEDURE
No.: MT95
EQUIPMENT QUALIFICATION
Date of Issue
Functional Design
Specification (FDS
): Functional design
specification is a document
that
specifies in a complete, precise, variable manner,
the requirement design,
behaviour or
other characteristics of a system or component and
often the procedures
for determining
whether these provisions have been satisfied.
Specification that is offered by
manufacturing based on URS and are agreed
mutually.
Design
Qualification (DQ):
Formal and
systematic verification that the requirements
defined in the specification phase are
completely covered by the succeeding
specification or implementation phase.
Factory Acceptance Test
(FAT):
Testing conducted at the
suppliers factory to
determine whether
or not a system specifies it’s acceptance criteria
and to enable the
user to
determine whether or not to accept the system.
PREPARED BY
Department Head
Date :
(CQA-56/F3/4)
APPROVED BY
Date :
AUTHORISED BY
Unit Head
Unit Quality
Assurance
Date :
Installation
Qualification (IQ):
Documented
verification that a system is installed
according to written and pre-approved
specifications.
卑微如蝼蚁、坚强似大象
Cipla
Patalganga
STANDARD OPERATING PROCEDURE
No.: MT95
EQUIPMENT QUALIFICATION
Date of Issue
Site Acceptance
Test (SAT):
An acceptance test at the
users site, usually involve the
supplier.
Operation Qualification
(OQ):
Documented verification that a
system operates
according to written
and pre-approved specification throughout all
specified operating
ranges.
PLC Validation:
Documented verification that PLC Hardware are as
per original
drawing, Digital and
Analog Input and Output are connected as per PLC
Architecture
and functioning according
to written and pre-approved specification
throughout all
specified operating
ranges.
Performance
Qualification (PQ):
Documented
verification that a system is capable of
performing or controlling the
activities of the processes, it is required to
perform or
control, according to
written and pre-approved specifications, while
operating in its
specified operating
environment.
User (s):
The person, or persons, who operate or
interact directly with the system.
Supplier:
Any organisation
or individual contacted directly by the user to
supply a
product or service.
卑微如蝼蚁、坚强似大象
Cipla
Patalganga
STANDARD OPERATING PROCEDURE
No.: MT95
EQUIPMENT QUALIFICATION
Date of Issue
Critical
Equipment:
The machine within a system
where the malfunctioning or failure
of
equipment will have direct impact on product
quality. Where product is in direct
contact with machine body parts.
Non-critical
Equipment:
The machine within a system
where the malfunctioning or
failure of
equipment will not have direct impact on product
quality. Where product is not
in
direct contact with machine body parts.
1.0
HEALTH,
SAFETY AND ENVIRONMENT: (
对验证实施人员的
HES
要求
)
1.1
Personnel involved in
qualification / re-qualification / periodic
qualification
should use appropriate
personal protective equipment.
1.2
Do not touch
the moving parts.
1.3
Electrical isolation should be done
before any electric control panel
verification.
1.4
Read the safety
instructions specified in the operation Manual of
the
machine to be qualified.
卑微如蝼蚁、坚强似大象
Cipla
Patalganga
STANDARD OPERATING PROCEDURE
No.: MT95
EQUIPMENT QUALIFICATION
Date of Issue
2.0
PROCEDURE:
2.1
Equipment qualification
should be based on the following documents
2.1.1
User
Requirement Specification (URS)
2.1.2
2.1.3
2.1.4
2.1.5
2.1.6
2.1.7
2.1.8
2.1.9
Functional Design
Specification (FDS)
Design
Qualification (DQ)
Factory Acceptance
Test (FAT)
Checklist on Receipt
Installation Qualification (IQ)
Operation Qualification (OQ)
PLC Validation ( If applicable)
Provisional Handover Certificate
2.1.10
Performance
Qualification (PQ)
2.1.11
Handover Certificate
The
flow of the equipment qualification is as follows
URS
?
FDS
?
DQ
?
FAT
?
IQ
?
OQ
?
PLC Validation (if applicable)
SAT
?
PQ
卑微如蝼蚁、坚强似大象
Cipla
Patalganga
STANDARD OPERATING PROCEDURE
No.: MT95
EQUIPMENT QUALIFICATION
Date of Issue
2.1.1
User
Requirement Specification (URS):
2.1.1.1
URS
protocol
should
be
approved
by
the
project
team
(Users) members and Quality Assurance
with Name, Sign
and Date.
2.1.1.2
Following
points
should
be
considered
during
the
development of URS.
?
Introduction
?
Over view
?
Operation
requirements
?
Constraints
?
Life cycle
?
Glossary
?
References
?
Approval
2.1.1.3
Each URS protocol should be allotted
with a protocol no. in
the format
specified below
“URS/P”
Where,
卑微如蝼蚁、坚强似大象
Cipla
Patalganga
STANDARD OPERATING PROCEDURE
No.: MT95
EQUIPMENT QUALIFICATION
Date of Issue
“URS” stands for
Use
r requirement specification.
“P” stands for equipment / instrument /
balance / area
abbreviated code.
2.1.1.4
The protocol should
also identify with a Version No. Where
the version no. changes with every
change in the URS.
2.1.1.5
The URS protocol header should consist of the
following details
as mentioned below:
?
Title of the URS
?
Protocol No.
?
Version No.
?
Date
?
Cipla
Patalganga
?
Unit
?
Page No.
A specimen of
the header is given below:
Protocol No.:
URS/P
Version
No.:
Date:
卑微如蝼蚁、坚强似大象
TITLE
Cipla Patalganga
Unit:
Page x of
y
Cipla
Patalganga
STANDARD OPERATING PROCEDURE
No.: MT95
EQUIPMENT QUALIFICATION
Date of Issue
2.1.2
Functional Design Specification
(FDS):
2.1.2.1
The
FDS
should
be
the
manufacturer
interpretation
of
URS.
FDS
should
include
basic
functioning
of
the
equipment
with focus on control and critical components
specifications and functions.
The
FDS
should
be
in
the
form
of
separate
document
and
should
include
equipment
specification,
P&ID
diagrams.
The FDS protocol / report should be
mutually approved
by the user and
supplier with sufficient technical details
based on the techno commercial offer.
The supplier is finally selected and
CER is raised.
Any changes made after
finalisation of DQ should under
go
change control procedure as per SOP CQA 06.
2.1.2.2
2.1.2.3
2.1.2.4
2.1.2.5
2.1.3
Design Qualification
(DQ):
卑微如蝼蚁、坚强似大象
Cipla
Patalganga
STANDARD OPERATING PROCEDURE
No.: MT95
EQUIPMENT QUALIFICATION
Date of Issue
2.1.3.1
2.1.3.2
Following
points
should
be
considered
during
the
development of design
qualification.
?
Purpose
?
Scope
?
Responsibility
?
Project requirement
?
Critical variables to be
met
?
Process/ Product
parameters e.g. Capacity etc.
?
cGMP considerations
e.g. MOC of individual parts,
finish of contact parts
?
Critical parameters e.g. Instrumentation, limits,
?
Safety
?
Location
suitability
?
References
?
Documents to
be attached.
?
Any changes
made against the formally agreed
parameters (Deviation if any).
?
Justification for
acceptance (if any deviation)
?
Review (Inclusive of
follow up action, if any)
?
Recommendation
Design qualification should be based on
the discussion
between
the
supplier
and
the
user
with
reference
to
URS
/ FDS.
卑微如蝼蚁、坚强似大象
Cipla
Patalganga
STANDARD OPERATING PROCEDURE
No.: MT95
EQUIPMENT QUALIFICATION
Date of Issue
2.1.3.3
?
Signing off
Any
change in DQ should be through a change control
procedure
as
per
SOP
CQA-06
and
should
be
documented.
2.1.4
Factory Acceptance
Test (FAT):
2.4.1
The
FAT
should
be
conducted
at
the
supplier’s
premises
under the users
supervision unless agreed upon.
2.4.2
The FAT protocol /
report should be prepared by the supplier
as
per
Manufacturers
format
and
should
be
submitted
for
approval of user.
2.4.3
The
equipment
should
be
shipped
to
the
site
only
after
approval by the user.
2.4.4
The FAT
protocol / report should include details of the
URS
and FDS.
2.4.5
Any modification,
changes needs during the FAT should be
documented
and
intimated
to
the
user and
carried
out
with
mutual
consent.
卑微如蝼蚁、坚强似大象
Cipla
Patalganga
STANDARD OPERATING PROCEDURE
No.: MT95
EQUIPMENT QUALIFICATION
Date of Issue
2.1.5 Checklist
on Receipt:
2.1.5.1
2.1.6 Installation
Qualification (IQ):
2.1.6.1
All aspects such as utility
connections, location suitability,
material of construction of critical
parts, installation of all
monitoring,
controlling, instruments and gauges including
their
calibration
and
certification
by
supplier
should
be
checked
and verified.
During the installation
qualification Area Lux level, Floor
drains, piping connections , machine
alignment, levelling,
P&
ID
Diagram,
Schematic,
circuit
diagram,
tagging,
wiring
pheruling,
pneumatic
connections
considered
during design qualification are checked
and verified.
All
critical
parts
of
equipment
should
be
checked
for
finish,
any
damages
on
receipt
for
availability
as
per
packing list and order
details.
2.1.6.2
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