I.
PURPOSE
The purpose
of this SOP is to define a procedure for procuring and qualifying the equipment
being installed. The qualification of equipment is carried out to provide a
high degree of assurance that the equipment meets all the design
specifications, operates under the requisite conditions, and performs
consistently.
II. SCOPE
This SOP is applicable to any critical equipment and
ancillary systems which are involved in production of intermediates and APIs at
Aurobindo Pharma Limited, Pashamylaram, Unit - V.
1.0 When procuring
new equipment / system
2.0 When the existing equipment / system is
subjected for up-gradation or modification.
III.
RESPONSIBILITY
User
department to prepare User Requirement Specifications (URS).
Process
engineer to prepare the Data sheet.
Projects
department to approve the Data sheet and prepare the Design specification,
Techno commercial comparison statement.
Engineering & Utility department to initiate
and evaluate the equipment qualification in coordination with respective
department and Quality Assurance department is responsible to approve the
qualification procedure.
IV. ACCOUNTABILITY
Head
Projects and Head QA
V. PROCEDURE
1.0 Design
development shall be carried out prior to purchase of new equipment and process
approach consisting the following steps
1.1
User Requirement Specification (URS)
1.2
Data Sheet (DTS)
1.3
Design Specification (DSP)
1.4
Techno Commercial Comparison Statement (TCS)
1.5
Factory Acceptance Test (FAT)
1.6
Site Acceptance Test (SAT)
1.1
User Requirement Specification (URS)
1.1.1
User Requirement Specification shall be prepared as a
basis for designing any equipment or system to be procured from an external
agency.
1.1.2
User Requirement Specification for all major equipments
shall be prepared by user department in consultation with engineering,
projects, and external agency as per Format F01/SOPQA003-00.
1.1.3
Project Manager purchases the equipments / instruments
/ system for its manufacturing / testing facility.
1.1.4
User Requirement Specification for equipments /
instruments / system shall cover appropriate design, adequate size, and
suitable location to facilitate operations for its intended use and for its
cleaning, maintenance, safety, and general GMP requirement.
1.1.5
URS is prepared to document the expectations of
Aurobindo Pharma Limited from the suppliers of the equipment or system, which
should be suitable to the process and regulatory requirement and to comply the
performance criteria by the APL.
1.1.6
Persons with adequate knowledge of the process and
regulatory requirements shall review and approve User Requirement Specification.
1.2
Data sheet (DTS)
1.2.1
Process Engineer shall prepare the Data Sheet for
enquiry purpose based on URS as per Format F02/SOPQA003-00.
1.2.2
Data sheet shall be approved by Project and Quality
Assurance departments.
1.2.3
Project Manager shall send the Data Sheet to number of
suppliers, who are capable to supply or fabricate the equipment / system and
receive comments and supplier specifications.
1.2.4
The response of the suppliers shall meet the
expectation of the project manager as per the specifications mentioned in the
Data sheet.
1.3
Design Specification (DSP)
1.3.1
Based on the supplier response and Data sheet, a
detailed engineering specification called as Design Specification (DSP) shall
be prepared by Projects department as per Format No: F03/SOPQA003-00 and
compared with URS and Data Sheet by competent team of Projects in consultation
with User & Engineering department, that all specifications of URS has been
considered in DSP.
1.3.2
Project Department and Quality Assurance Approves the
Design Specification (DSP) and the approved Design Specification will be sent
to vendors again.
1.4
Techno Commercial Comparison Statement
1.4.1
From an iterative process of discussions with potential
suppliers, a Techno Commercial Comparison Statement is prepared as per the Format No. F04/SOPQA003-00.
1.4.2
Based on this Techno Commercial Comparison Statement a
particular vendor is selected.
1.5
Before placing the order the project manager should
ensure that any development of the specification and user requirements are
fully discussed and the supplier is aware of all requirements pertaining to the
supply of equipment, necessary documentation, testing procedures, installation,
maintenance and operation procedures.
1.6
Many of these documents will be key both to the
engineering design and to the final equipment qualification and operation.
1.7
The Blank formats of User Requirement Specification,
Data sheet and Design Specification are maintained in the electronic format and
fill the forms electronically below the side headings. The contents may vary as
per the requirement of process / system.
1.8
The Design Specification shall be confirmed in Design
Qualification for critical systems like AHU, Water system.
1.9
All equipments, instruments, or system specification
reflects the approach of Aurobindo Pharma Limited to comply all GMP
requirements, Regulatory requirements.
1.10
Factory Acceptance Test (FAT)
1.10.1
After completion of equipment fabrication, manufacturer
shall send the intimation to the projects department.
1.10.2
Design of equipment shall be confirmed thorough Factory
Acceptance Test before shipment to the site for installation.
1.10.3
The Factory Acceptance Test protocols shall be prepared
by the Projects or Supplier or by Third party. After pre approval of this
protocol, it will be used to carry out FAT.
1.10.4
The Project and QA team shall review the protocol and
approve the same. The competent personnel from APL or personnel assigned by APL
shall visit the site of fabrication and check the equipment as per the approved
Factory Acceptance Test protocol.
1.10.5
Receive the equipment in the site, after Factory
Acceptance Test approval.
1.11
Site Acceptance Test (SAT)
1.11.1
After receiving the equipment or installing the new
system in the site, the vendor shall carry out SAT in presence of the user
department and Engineering & Utility department.
2.0 Qualification
2.1 Before starting
process validation activities, appropriate qualification of equipment and
ancillary systems should be completed. Qualification is usually carried out by
conducting the following activities, individually or combined
2.1.1 Design Qualification (DQ): documented
verification that the proposed design of the facilities, equipment, or systems
is suitable for the intended purpose.
2.1.2 Installation Qualification (IQ):
documented verification that the equipment or system, as installed or modified,
comply with the approved design, the manufacturer’s recommendations, and/or
user requirements.
2.1.3 Operational Qualification (OQ):
documented verification that the equipment or systems, as installed or
modified, perform as intended throughout the anticipated operating ranges.
2.1.4 Performance Qualification (PQ):
documented verification that the equipment and ancillary systems, as connected
together, can perform effectively and reproducibly based on the approved process
method and specifications.
2.2 Well defined
protocol should be written for carrying out the qualification of equipment in
the above said stages and the protocol contain the following sections.
2.2.1
Protocol Approval
2.2.2
Objective
2.2.3
Scope
2.2.4
Responsibilities
2.2.5
Execution team
2.2.6
Description of Equipment
2.2.7
Qualification of Procedure
2.2.8
Deficiency and Corrective action Report
2.2.9
Summary and evaluation of results
2.2.10
Post Approval
2.3 The Qualification
protocol log shall be maintained by QA as per the format F05/SOPQA003-00.
2.4 Protocol serial
no. will be assigned serially for that particular year.
2.5 The Qualification
Procedure starts with Design Qualification for new equipment, instrument, and
system.
2.6 The Design
Qualification verifies the proposed design of the facilities, equipment, or
system is suitable for intended purpose and as per GMP requirements.
2.7 After compliance
of the Design Qualification, the installation of equipment shall be carried out
as per the IQ protocol.
2.8 The Installation
Qualification protocol should include the verification of the equipment details
with the
2.8.1
Equipment description.
2.8.2
Acceptance criteria.
2.8.3
Equipment / system identification.
2.8.3.1
Identification of major components/Accessories
2.8.3.2
Identification, Classification & Verification of process
control instruments
2.8.3.3
Identifications of the contact surfaces
2.8.3.4
Identifications of the documents
2.8.3.5
Identification of Utilities
2.8.4
Installation checks / review.
2.8.5
Inspection checks / review.
2.8.5.1
Inspection of major component/ Review
2.8.5.2
Inspection of instruments, indicators, sensors/Review
2.8.5.3
Inspection of contact surfaces/Review
2.8.5.4
Inspection of utilities/Review
2.8.5.5
Inspection of documents
2.8.6
Deficiency and corrective action report
2.8.7
Summary and evaluation of results
2.8.8
Equipment installation location, date of installation,
signature of the person who carried out installation.
2.9 All details
pertaining to installation of the equipment shall be documented and approved by
Quality Assurance.
2.10 Operational
Qualification phase is intended to check whether the equipment is operating as
per the manual specifications, design specifications, and GMP requirements.
2.11 The respective
department personnel shall write the procedure as to how the equipment should
be operated after installation of the equipment based on the equipment manual.
2.12 The personnel
carry out the operation of the equipment as per procedure.
2.13
The operational qualification documentation should
fulfill
2.13.1
Critical instruments calibration
2.13.2
Test functions.
2.13.3
Safety features.
2.13.4
Verification of Standard operating procedures.
2.13.5
Simulation cycles.
2.13.6
Operation results.
2.13.7
Deficiency and corrective action report.
2.13.8
Summary & Evaluation of results.
2.13.9
Operational runs, operational dates, signature(s) of
the person who operated the equipment.
2.14
All details related to operation of the equipment shall
be documented and approved by Quality Assurance.
2.15
If the equipment operates within the specified
operational parameters and tolerances, the equipment is operationally qualified
and now it is ready to carry out performance qualification.
2.16
The activities to be carried out with respect to
performance qualification shall be defined in the protocol.
2.17
The number of tests/ challenges and trial runs to be
carried out for the purpose of the validation shall be maintained in the
protocol. The tests/ challenges should be repeated sufficient number of the
trials are carried out and then compared against the preset parameters.
2.18
If the results obtained are found consistence and in
accordance with acceptance criteria, the equipment shall be concluded to be
performing satisfactorily and hence qualified the equipment for regular use.
Any test / challenge shows that the equipment does not perform as per the
specification an investigation shall be carried out to identify the cause of
failure.
2.19
All the details of pertaining to performance of the
equipment shall be documented and approved by Quality Assurance.
3.0 The number
assignment system for documents shall be written in alphanumeric type, consists
of ten characters, which are as follows.
3.1 Syntax
XXX - XXXXXX
Equipment Number as described in
Equipment Numbering System SOP. 
Dash
Alphabetical to denote the type of
documents as listed below.
User
Requirement Specification (URS)
Data
Sheet (DTS)
Design
Specification (DSP)
Techno
Commercial Comparison Statement (TCS)
Factory
Acceptance Test (FAT)
3.2
Typical Example of User Requirement Specification for
SS Reactor is
URS-SRA101
– User Requirement Specification of Stainless steel reactor, which is to be
located in the Production block A at Module 1.
4.0 List of
Formats
|
Format
No.
|
Purpose
|
|
F01/SOPQA003-00
|
User
Requirement Specification
|
|
F02/SOPQA003-00
|
Data
Sheet
|
|
F03/SOPQA003-00
|
Design
Specification
|
|
F04/SOPQA003-00
|
Techno
Commercial Comparison Statement
|
|
F05/SOPQA003-00
|
Qualification
Protocol log
|
VI. REVISION
SUMMARY
|
Version No.
|
Revised on
|
Reason for Revision |
|
00
|
NA
|
NA
|
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