1.0) OBJECTIVE:
Objective of this SOP is to describe the basic requirements for carrying out the design, installation, commissioning, “Operational/Performance” qualification of new and modification to existing production and non-laboratory based equipment used for Drug Product manufacturing including involved utilities.
2.0) SCOPE:
The SOP is applicable to all qualification activities preventive maintenance
3.0) RESPONSIBILITY:
Department Officer will be responsible for implementation of SOP.
User will be responsible to qualify new equipment as per this SOP.
Department Officer will be responsible to conduct periodic review of qualified equipment.
Department Officer will be responsible to ensure that appropriate User Requirement Specification (URS) is established for any new equipment/ system.
Vendor will be responsible to conduct design qualification (DQ).
Engineering department will be responsible to conduct Installation and Operational Qualification.
User department will be responsible to conduct performance qualification (PQ) of the equipment / system.
QA representative will be responsible for final review and authorization of qualification / validation document.
The whole activity of commissioning and qualification of equipment / system should be monitored & checked by Quality Assurance.
4.0) ACCOUNTABILITY:
Engineering Department Head, Production Department HeadeadGea & QA Head shall be accountable for implementation of this SOP.
5.0) ATTACHMENTS:
Exemplary Template for URS – Attachment-I
Exemplary Template for IQ – Attachment-II
Exemplary Template for IQ Checklist – Attachment-III
Exemplary Template for PQ – Attachment-IV
Exemplary Template for periodic review – Attachment-V
Exemplary Template for Impact Assessment checklist – Attachment-VI
Exemplary Template for One Time Installation – Attachment-VII
6.0 PROCEDURE:
6.1 Requirements:
6.1.1 All critical equipment and systems procured after effective date of this SOP should be qualified as per the procedure given in this SOP. Qualification should be carried out by conducting DQ, IQ, OQ and PQ activities, individually or combined.
6.1.2 Periodic review of equipment / system should be initiated to verify that they are still operating in a valid manner and to assess if there is any need for requalification. The template for periodic review is given as Attachment 5. Such review for qualified equipment / system should be done after every 5 years. Tolerance for periodic review is +/- 3 months.
6.1.3 Qualification of established equipment must verify that data are available to support the critical operating parameters and limits of the equipment. P & ID, wiring diagrams and other documentation, as applicable.
6.1.4 For large systems such as Air handling system and water system, separate validation protocol can be established. Separate validation report should be prepared for such systems after completion of the activity.
6.1.5 Qualification activities performed and documented by suppliers or contractors will preferably be agreed upon as part of the bid/quotation process. All qualification documents issued by suppliers/contractors must be reviewed by Export of Sano-cito representative.
6.1.6 Changes made till completion of OPQ should be documented and traceable. Appropriate change control procedure should be followed for any change to be made in equipment/ system after OPQ. This includes the engineering drawings of equipment/ system.
6.1.7 Equipment / System should be classified as Direct Impact System, Indirect Impact system, and No Impact system. Also Risk assessment of the equipment should be done. Depending on classification whether complete qualification (DQ, IQ, OQ & PQ) or Commissioning Report (DQ & One Time Installation Report) to be prepared.
6.2 User Department
6.2.1 User should prepare URS for the system / equipment required or for any change in existing system/ equipment. The specimen template for URS is given as Attachment-I.
6.2.2 Send the URS to Engineering department for inputs with respect to –
– Specifications of PLC / Control systems
– Suggestion for manufacturer of Equipment/Instrument
– Settable parameters
– Accuracy of field instruments
– Accuracy of measuring instruments
– MOC for non-contact parts, etc.
6.2.3 User Requirement Specification
General
- Equipment No.
- Description
- Use
- Field identification
Salient Features
- General
- Material of construction
- Electrical construction
Operational requirements
- Capacity
- Control Parameter
- Control
- Functional requirements
- Power failure/recovery
Utilities
Maintenance
Commissioning and documentation
Development
Training
- Start up support
- Post start up support
Packaging
Deviations
Delivery
6.2.4 Factory Acceptance Test
System description
System Checks
- Physical check
- Basic component verification
Verification of Safety & Interlock Feature
Functional Verification
- Basic Challenge test
Access Level Security
Trail Report
6.2.5 Site Acceptance Test
6.2.6 Installation Qualifications
- Document and drawing verification
- Verification of technical specification for In-House & sub –components/Bought out items
- Utilities Verification
- Material of construction verification
- Critical instrument calibration verification
- Installation Qualification test status
6.2.7 Operational Qualification
- Main panel/control panel testing
- Power & Communication Failure Recovery Verification
- Safety Feature Verification
- Variable RPM verification
- Operational Qualification Test status
- List of standard Operating procedure
6.2.8 Performance Qualification
- System Description
- Equipment Identification
- Description of operation
- Standard operating procedure established during Operation Qualification
- Performance Qualification procedure
6.3 Engineering department
6.3.1 Review the URS and specify the scope of the project-related documentation which is required for equipment module or piece of equipment.
6.3.2 The design of equipment must include, but may not be limited to the following documents:
- Process and Instrumentation Diagrams (P&ID) including:
– Equipment lists
– Instrument lists
– Engineering / technical specifications
6.3.3 At this stage the scope of the required vendor documentation must also be defined. In addition to some of the above mentioned documents, this may include:
- Dimensioned outline drawing
- Fabrication/construction drawings
- Vendor data sheets
- Certificates such as::
– Material of Construction certificates
– Third party inspection certificates
– Inspection and test reports
– Recommended spare parts lists
– Maintenance procedures
– Operating description
– Cleaning requirements
– Testing certificate
– Calibration reports
6.3.4 Send the copy of URS to prospective supplier(s) and invite for the bids/quotations.
6.3.5 On receipt of bid/offer from supplier(s), compare the offer against URS.
- Identify the most suitable vendor.
- Place the purchase order for the short listed vendor (supplier).
6.3.8 After placing the purchase order, ensure that following information is provided by the vendor.
- Equipment drawing
- Layout of equipment with orientation
- Fabrication drawing
- Detailed P & ID
- Electrical circuit diagram
- Support/ instrumentation details
- Control system details
- PLC block diagram
- Interlock list
- MOC details
- Datasheet of ‘critical’ bought out items
6.3.9 This is not an all-inclusive list and can vary depending upon type of equipment / system.
6.3.10 “Impact assessment / Risk Assessment” to be performed based on No Impact, Indirect Impact and Direct Impact, and rational should be provided that classifies plant/facility and equipment as having a ‘Direct Impact’, ‘Indirect Impact’, or ‘No Impact’ on product quality. Refer Attachment-VI for classifying the equipment/system.
6.3.11 For Indirect Impact System, Commissioning to be done. For commissioning One Time Installation format (Attachment-VIII) can be used.
6.3.12 For Direct Impact System, Design Qualification must be performed and checked against the identified critical elements by the responsible project engineer and by any other department (i.e Safety, Production, QA, etc). After first approval, each DQ document, drawing or data must follow approved change control procedures throughout the life cycle.
6.3.13 During the Design Qualification (DQ), the suppliers offer is compared with the URS.
6.3.14 In case of Direct Impact system conduct Installation Qualification (IQ) to verify that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations and/or user requirements.
6.3.15 The installation of equipment, piping, services and instrumentation must be checked against piping & instrument drawings (P & ID) or other relevant schematics and this check must be documented.
6.3.16 Equipment IQ records should address items such as:
- Positioning / orientation / fastening
- Coupling alignment (rotating equipment)
- Internals
- Utility connections (heating/cooling medium, air, etc.)
- Insulation
- Equipment cleaning
6.3.17 Instrument / electrical IQ records should address items such as:
- Power connections
- Rotation check
- Instrument hook-up
- Access for maintenance and calibration
- Instrument wiring / continuity checks, loop checks, I/O checks, etc
6.3.18 Piping IQ records should address items such as:
- Pipe line fabrication records (material conformity and welding)
- Adherence to piping specifications and isometric requirements (slope, dead legs, supports, etc.)
- Gasket material
- Cleaning
6.3.19 Certificates received from supplier, as appropriate, should be verified during IQ. For examples:
- MOCs of contact parts
- Calibration
- Surface finish
- Test certification
- Confirmatory certificates
- Filter integrity
6.3.20 Equipment to be entered in equipment record book, with its details and planning of the equipment for Preventive Maintenance to be done.
6.3.21 Document the IQ activity. Exemplary template for IQ is given as Attachment-II. The test results can be documented in site-specific/vendor-specific test report formats and attached to IQ. Installation checklist as per Attachment-III can be used.
6.3.22 Ensure that instruments are within state of calibration prior to start of Operational Performance Qualification. This verification can be documented in OPQ template under section 4 (Instruments and/or Device). In justified cases the calibration can be performed during the PQ.
6.3.23 In case of Direct Impact System conduct the Operational / Performance Qualification (OPQ) to verify that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges.
6.3.24 Tests must include conditions encompassing upper and lower processing or operating limits (worst case conditions). Such conditions should not impact product or process failure.
6.3.25 Document the OPQ activity. Exemplary template for OPQ is given as Attachment 4. The test results can be documented in site-specific/vendor-specific test report formats and attached to OPQ.
6.4 User Department
6.4.1 In coordination with Engineering and Vendor, organize for training to operators.
6.4.2 The completion of satisfactory installation Qualification and Operational/Performance Qualification exercises should permit a formal “release” of the equipment/plant.
6.4.3 Establish appropriate SOPs for operation and cleaning of equipment.
6.5 QA
6.5.1 Review the Installation and Operational / Performance qualification documents.
6.5.2 Ensure that appropriate training is provided to operators.
6.5.3 Ensure that calibration, cleaning and preventive maintenance SOPs, as applicable, are established for equipment/ system.
6.5.4 Release the equipment / system for production. If only OQ is performed, release the equipment for PQ.
6.6 User Department
6.6.1 In case of Direct Impact System, conduct Performance Qualification (PQ) to verify that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications.
6.6.2 Performance Qualification (PQ) must follow approved test specification according to the plan. The specification used for the OQ testing could apply for PQ.
6.6.3 Performance tests must demonstrate that the equipment related system or subsystems perform as specified within the user requirement specification. The critical parameters and acceptance criteria to be met must be specified in advance in the test specification.
6.6.4 Prepare the report. This can be process validation report if PQ is done during validation exercise.
6.7 QA
6.7.1 Review and approve the summary report.
6.7.2 Procedure for periodic review of exiting equipment / systems.
6.8 User Department.
6.8.1 Conduct the periodic review of existing critical equipment and systems to assess need for re-qualification.
6.8.2 Document the review in the template given as Attachment-V.
6.8.3 Conduct the re-qualification if indicated in the review report.
6.8.4 Execute all other activities as recommended in periodic review.
6.9 QA
6.9.1 Review the periodic review of equipment/ system.
6.9.3 Ensure that recommendations given in the report are completed.
.
7.0 REFERENCES:
In-house
8.0 ABBREVIATIONS:
SOP: Standard operating procedure
QA: Quality Assurance department
DQ: Design Qualification
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
OPQ: Operational & Performance Qualification
URS: User Requirement Specification
- DISTRIBUTUON LIST:
Quality Assurance
Engineering
Production
- HISTORY OF REVISION:
| Version Number | Effective Date | Reason for Revision |
| 00 | – | New SOP. |
