The purpose of this procedure is to outline the Guidelines for Equipment Installation Qualification (SOP) requirements and acceptance criteria for the critical equipment serving to Pharmaceutical Limited facility. This Standard Operating Procedure outlines the guidelines for Equipment Installation Qualification (IQ) at pharmaegg.com. Guidelines for Equipment Installation Qualification (SOP) is a critical step in ensuring that newly acquired equipment is properly installed, calibrated, and ready for use. Adhering to these guidelines guarantees the integrity, accuracy, and reliability of the equipment, contributing significantly to the quality and consistency of our research and development efforts.
Guidelines for Equipment Installation Qualification (SOP) location and purpose of the equipment should be notified and described. Successful IQ completion of these equipment’s will provide the assurance that the equipment has installed as required by the manufacturer and processing environment. The primary objective of this SOP is to establish a standardized approach for the Installation Qualification of equipment. By following these guidelines, we aim to confirm that the equipment is installed correctly, according to the manufacturer’s specifications, and meets all the necessary requirements for safe and effective operation.
This procedure applies to all equipment’s lying with facility for the completion of their Installation Qualification (IQ). This qualification must be completed prior to manufacture of product for process validation.
The responsibility for Equipment Installation Qualification lies with the designated personnel responsible for procurement and equipment management. The equipment manager, along with the technical team, will oversee the implementation and compliance of this protocol.
Installation Qualification (IQ):
Guidelines for Equipment Installation Qualification (SOP) is the process, which establishes through verification and documentation that the equipment exists and is installed according to specification, such as SOPs, drawings, parts lists, calibration methods etc. and for each piece of equipment, if required.
Critical Manufacturing Equipments:
Critical manufacturing equipments are those which have direct product contact or may have the potential affect on the quality of the product. All critical manufacturing equipment must be included in the change control program once satisfactory IQ has been installed.
All required Guidelines for Equipment Installation Qualification (SOP) verifications must be performed and, if applicable, all corresponding data collection forms must be completed.
All amendments and deviations must be adequately resolved and approved by the appropriate individuals prior to use of the equipment for manufacturing process.
Engineering Department (or Equipment Supplier):
- Compilation of IQ report and list of equipment’s parts.
- Providing testing data for review, upon request.
- Coordinating for the qualification with the appropriate individuals and departments.
- Verifying that the qualification test requirements are completed.
- Establishing appropriate Preventive Maintenance and Calibration programs and schedules.
- Calibration of all the manufacturing equipments, if applicable. All calibration documentation must be available with the Engineering department.
Overall adherence to this work instruction.
Verifying that the report requirements are completed and prepared for approval.
To review qualification in the final reports.
To review and approve the qualification data and prepare the final report.
The Guidelines for Equipment Installation Qualification (SOP) of the new manufacturing equipment will be verified by reviewing the equipment installed and the specifications using the data collection forms, to document that the equipment components conform to designed specifications. In addition, Engineering documentation will be reviewed and compared to the installed equipment. For existing equipment, review available documentation.
Validation coordinator should document all qualification inspections and verifications at the time they are performed.
If the inspection or verification test is not satisfactory, complete a deviation report form to document the deviation (if any). Indicate any corrective action or other appropriate action taken and submit for approval.
Upon completion of all documentation, prepare an IQ Summary Report for the evaluated equipment. Summarize the results of all performed qualification studies. Include an explanation of deviations from the specifications, report procedures or acceptance criteria.
A determination of specification must be performed based on available documentation (i.e. as built drawings, operating manuals, operating SOPs, etc.)
The following are the basic IQ requirements for all equipments; however these may vary equipment to equipment. These requirements should comply IQ guidelines.
Complete a list of specifications, purchase orders, and manuals associated with the equipment.
Record all P & ID’s (Piping and installation Drawings) intended to reflect the equipment “as built” using the “As Built” Engineering Drawing data collection form. Verify the accuracy of these drawings.
Complete an equipment list based on information from purchase orders and equipment specifications. Verify that the items have been installed as specified. Indicate fixed asset number, equipment serial number, manufacturer and description of each item, as applicable. Indicate the location where recommended spare parts listings may be found.
Electrical Utility Verification:
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. All circuit protection devices will be check listed prior to verification.
Non-Electrical Utilities Verification:
Complete a list of all requirement utilities (non-electrical). Verify that they are available and conform to specifications. Inspect the connections from the distribution system. Include any documentation in support of the results and method of verification.
Complete a filter list based on information from purchase orders and equipment specifications. Verify that the items have been installed as specified. Indicate position number, equipment code number, manufacturer and description of each item, as applicable.
Product Contact Material Review:
Identify the materials of construction of product contact surface of the equipment components. Verify that they conform to specifications and will not adversely affect the product.
Complete a list of the lubricants used in the equipment. Verify that they conform to the equipment manufacturer’s specifications.
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 only and are labeled as “Reference Only”. Include tag number, manufacturer, location, and description of each item, as applicable.
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 life.
Work Instructions/Procedures Review:
Assure that all associated SOPs /Instructions/Procedures are available, complete, current, accurate and in compliance with cGMP (i.e. Preventive Maintenance, Calibration etc.)
Equipment Control System:
Identify and document the equipment control panels. Confirm that control panels are installed in conformance with design and/or manufacturing specifications.
Qualification Completion and Approval:
Verify that all tests required by this guideline are completed, reconciled and attached with the summary report. Verify that all amendments and deviations are documented, approved and attached to the report. If all items in the Equipment Installation Qualification have been reviewed and found to be acceptable, approve the report.
By adhering to this Guidelines for Equipment Installation Qualification (SOP) we ensure that equipment is installed correctly, calibrated accurately, and ready for use. Following a standardized approach for Equipment Installation Qualification enhances the efficiency and reliability of our laboratory operations, supporting the integrity of our research activities.