SOP for Installation, Operational and Performance Qualification of Equipment/ Instruments

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

Head Engineering

4.0 ACCOUNTABILITY

Head QA, Head Production

5.0 PROCEDURE

5.1 Ensure the ID number is assigned and affixed to the equipment after receipt.
5.2 For the equipment/ instrument, 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 the 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 manufacturer/ 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 files

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, 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 by using moly kit.

5.3.5 Safety features and alarms

This section identifies and provides the list of safety interlocks and alarms for proper 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 procedures

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 perform as per the approved protocol and the protocol shall be prepared jointly by engineering and user department.
A typical operational qualification protocol for equipment shall cover various 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 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 equipment involved in the process with an 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 REQUIREMENTS FOR QUALIFICATION PROTOCOL

5.6.1 Each equipment qualification protocol shall have a 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, the protocol shall have a 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 re-qualification 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 the 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 the 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.

6.0 ABBREVIATION

6.1 SOP: Standard Operating Procedure

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