SOP for Installation Qualification Protocol and Formats is a critical phase in the validation process for equipment, systems, and utilities in regulated industries like pharmaceuticals, biotechnology, and medical devices. An IQ protocol is a document that outlines the procedures and criteria for the installation and verification of equipment. Below is an outline of an Installation Qualification Protocol along with suggested formats for key sections:
INTRODUCTION
Installation Qualification (IQ) is the process, which establishes through verification and documentation that the <Name of equipment> exists and is installed according to specification. Verification of appropriate documentation, such as, SOPs, drawings, repair parts lists, calibration methods, etc. for each piece of filter is required. Therefore Installation Qualification (IQ) of <Name of equipment> has to be done.
OBJECTIVE
The objective is to document that all key aspects of the <Name of equipment> has installed as per Vendor and Searle specifications. Successful completion of this equipment qualification will provide assurance that the <Name of equipment> has been installed as required by the manufacturer and the processing environment.
RESPONSIBILITY
Engineering:
- To provide the power and utilities supplies to be required for Equipment IQ.
- To provide appropriate personnel for installation verification.
- All critical gadgets, if applicable, must be calibrated.
- Notify the validation group of any major repairs, renovations or revisions made to the equipment or process, through the change control program.
Validation Coordinator:
- Write an IQ protocol
- Compilation and evaluation of the IQ report and all of its parts.
- Verifying that the qualification test requirements are completed.
- Coordinate with Engineering the investigation, documentation, and disposition of all IQ deviations that do not meet the acceptance criteria detailed in the respective manual of equipment.
- Fill required IQ formats
Quality Assurance:
- Review and approve the IQ protocol and final report.
EQUIPMENT DESCRIPTION
<Brief equipment description>
ACCEPTANCE CRITERIA
The acceptance criteria will depend on the certification that the installation of <Name of equipment> is consistent with its operating manual requirements.
PROCEDURE:
- The installation of <Name of equipment> will be qualified by visual inspection, evaluation and confirmation that the equipment installation conforms to design documents and all associated specifications from equipment manuals. These specifications will be written in available column(s) using data collection forms. In addition review available documentation.
- A test technician’s signature and/or initials and date within the designated formats indicate that the particular item(s) have been checked and found acceptable. An individual from the installation team will review each attachment section and sign and date the bottom of the page to indicate that all qualification requirements have been met and all documentation has been properly stored in its required location.
- If the inspection or verification test is found unsatisfactory, complete a Deviation and Discrepancy Form attached in this document. Indicate any corrective action or other appropriate action taken and obtain approval.
- Upon completion of all documentation attachments, prepare an IQ Summary Report for the evaluated equipment. Summarize the results of all performed qualification studies. Include an explanation of all deviations from the specifications, report procedures or acceptance criteria
ATTACHMENTS:
Data collection forms are provided as Attachments to this IQ. These documents will cover the necessary information required to successfully qualify <Name of equipment>. Use additional forms for any of the enclosed attachments to include all essential information necessary. Following is the filling criteria of these forms:
Engineering Documentation (Attachment #1
Complete a list engineering documents associated with the equipment. E.g. manual, commissioning report etc.
Engineering Drawings (Attachments #2)
Record all drawings/P&ID’s (Piping and Installation Drawings) intended to reflect the equipment “as built”. Verify the accuracy of these drawings.
Equipment procurement documentation (Attachment #3)
Verify that equipment procurement documents i.e purchase requisition, Invoice copy, comperative statement, delivery note, packing list etc.
Equipment List (Attachment #4)
Complete an equipment list (equipment specification and features) based on information from purchase orders and equipment specifications. Indicate position number (Fixed Asset/BMS Number), equipment code number, manufacturer and description of each item, as applicable. Indicate the location where recommended spare parts listings may be found.
Electrical Utility Verification (Attachment #5)
Verify that all recommended circuit protection devices are in place and that all circuit protection devices are sized in accordance with the manufacturer’s recommendation.
Non-Electrical Utilities Verification (Attachment #6)
Complete a list of all required utilities (non-electrical). Verify that they are available and conform to specifications. Inspect the connections from the distribution system.
Filter List (Attachment #7)
Complete a filter list based on information from purchase orders and equipment specifications.
Product Contact Material Review (Attachment #8)
Identify the materials of construction of product contact surfaces of the equipment components. Verify that they conform to specifications and will not adversely effect the product.
Lubricant List (Attachment #9)
Complete a list of the lubricants used in the equipment. Verify that they conform to the equipment manufacturer’s specifications.
Instrument List (Attachment #10)
Complete a list of all equipment instruments. Designate instruments as “critical” or “non-critical”. Critical instruments are used for process controls and are defined as those whose performance will affect the operation of the equipment or the quality attributes of the processed material. Non-critical instruments are those provided for information or convenience purposes only and are labeled as “Reference Only”. Ensure that all critical instruments/sensors have been calibrated as per applicable Calibration Control Procedure requirements. Verify that the re-calibration interval for critical instruments/sensors is indicated and that a copy of the completed calibration is on file.
Standard Operating Procedures/Instructions/Procedures Review (Attachment #11)
Assure that all associated SOP’s/Instructions/ Procedures are available, complete, current, accurate and in compliance with cGMP’s (i.e. Preventive Maintenance, Calibration, etc.).
Equipment Control system (Attachment #12)
For Computer and Automated Systems, refer to PSV Manual Volume V Identify and document the equipment control panels. Confirm that control panels are installed in conformance with design and/or manufacturing specifications.
Deviation and Discrepancy Report (Attachment #13)
If there is any discrepancy or investigation observed during installation from standard practice then this form have to be filled.
Note: If any above attachment is not applicable to this equipment qualification then fill that one with N/A (Not Applicable).
QUALIFICATION COMPLETION AND APPROVAL
Upon successful completion of the installation qualification the approval section will be completed signifying the installation of the equipment is acceptable and meets specification and process requirements
HISTORY
This document is the first Qualification Protocol written for <Name of equipment> installed in <name of facility> manufacturing facility.
Attachment Section/Installation Qualification/Data Collection Forms
Attachment #1
Engineering Documentation
Complete a list of manuals and any other documentation associated with the equipment
| Document # | Title | Date | Document Location | ||||||
| Searle Standard Specifications | |||||||||
| 1. | Installation, Start-up & Service Instructions Manual | ||||||||
| 2. | Installation Report of equipment from vendor | ||||||||
| Comments: | |||||||||
| Verified By: | Date: | ||||||||
| Reviewed By: | Date: | ||||||||
Attachment #2
Engineering Drawings
Record all drawings intended to reflect the IQ
| Drawing No. | Title | Drawing Checked | Location |
| Comments: | ||||
| Verified By: | Date: | |||
| Reviewed By: | Date: | |||
Attachment # 3
Equipment Procurement Documentation
| S.No | Document No. | Title | Date | Document Location |
| Comments: | |
| Verified By: | Date: | ||
| Reviewed By: | Date: |
Attachment #4
Equipment Specifications & Features
| Description | Required | Actual/ (OK) |
| Equipment Name | ||
| Model | ||
| Type | ||
| Serial Number | ||
| Worksheet Number | ||
| Asset Number | ||
| Installation Area | ||
| Manufacturer/Vendor Data | ||
Attachment #5
Electrical Utility Verification
Electrical Feeder Connections
| Equipment Name | Specified Volts | Specified Amps | Source Location | Power/ Phase | Area Classification | Grounding Required | Initial/ Date |
| All circuit breakers, terminal blocks properly identified: | o Yes o No |
| Comments: | . | |||
| Verified By: | Date: | |||
| Reviewed By: | Date: | |||
Attachment #6
Non-Electrical Utility Verification
Complete a list of required utilities (non-electrical). Verify that they are available and conform to specifications.
| Utility | Line Size | Service Requirements | Actual /OK | Utility Specification | Initial/ Date |
| Comments: | |
| Reviewed By: | Date: |
Attachment # 7
Filters List
Complete a list of Filters used on the equipment.
| SN | Filter (Class) | Type | Size | Unit | Qty | Verified by/Date |
| Comments: | |
| Verified By: | Date: | |||
| Reviewed By: | Date: |
Attachment #8
Product Contact Materials Review
Identify the materials of construction specific and/or vital to the equipment. Identify materials as Primary Contact (direct contact), Secondary Contact (not in direct contact but may affect product such as wash water), and Non-Contact (no contact with product), include utility piping where appropriate. Place a check (4) in the appropriate column describing the contact category.
| Item | Primary Contact | Secondary Contact | Non Contact | Material Specified | Actual/Ok | Approved for Product Contact (Yes/ No/NA) |
| Comments: | |
| Verified By: | Date: | |||
| Reviewed By: | Date: |
Attachment #9
Lubrication List
Complete a list of lubricants used on the equipment.
| Lubricant Used For | Recommended Lubricant or Equivalent | Manufacturer | Contact with Product (Y/N) |
| Comments: | |
| Verified By: | Date: | |||
| Reviewed By: | Date: |
Attachment #10
Instrumentation
Complete a list of all equipment instruments.
| Sr. # | Description/Location | Manufacturer ( Model/Serial ) | Calibration Required | Critical (Yes/No) | Verified By/ Date |
| 1 | |||||
| 2 | |||||
| 3 | |||||
| 4 |
| Comments: | |
| Reviewed By: | Date: |
Attachment # 11
SOPs / Procedures Review
Review the associated equipment SOPs for availability, completeness and compliance with GMPs.
| Originator | Document | Title | Date | Document Location |
| Not Available * | ||||
| Comments: | |
| Reviewed By: | Date: |
Attachment #12
Equipment Control System
Describe the control system, components and configuration for the equipment. If additional software or hardware validation is required, indicate the required documents and locations in the following table.
| Document Title: | Document Location: |
| Document Title: | Document Location: |
| Comments: | |
| Reviewed By: | Date: |
Attachment # 13
Deviation and Discrepancy Report
The following is a description of the deviations and/or discrepancies to this installation qualification.
| Reference (Section & Page): | —– | |||||
| Discrepancy/Variation: | ||||||
| Resolution: | ||||||
| Acceptable: o Yes o No | ||||||
| Signature | Date | |||||