Standard Operating Procedure for Documenting IQ/OQ/PQ Activities

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the process for documenting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities in pharmaceutical manufacturing. This SOP ensures that IQ, OQ, and PQ activities are properly documented to confirm that equipment, systems, and processes are properly installed, operated, and performing according to predetermined specifications. Accurate documentation of these activities is necessary for ensuring compliance with regulatory requirements and Good Manufacturing Practices (GMP), as well as verifying the effectiveness and reliability of manufacturing systems.

2) Scope

This SOP applies to all IQ, OQ, and PQ activities performed on pharmaceutical manufacturing equipment, systems, and processes. It covers the documentation of IQ/OQ/PQ protocols, data collection, testing, results, deviations, and corrective actions. The SOP applies to all new installations, requalification, or revalidation of systems or equipment, as well as ongoing qualification activities required to maintain compliance with regulatory standards.

3) Responsibilities

Operators: Responsible for executing IQ, OQ, and PQ activities according to the validated protocols and accurately documenting the results during testing.
Quality Assurance (QA): Ensures that the documentation of IQ/OQ/PQ activities is in accordance with this SOP, GMP, and regulatory requirements. QA is also responsible for reviewing and approving IQ/OQ/PQ protocols, data, and reports.
Validation Team: Develops and prepares IQ/OQ/PQ protocols, documents results, and ensures that all testing activities are conducted according to the established procedures.
Production Supervisors: Oversee the execution of IQ/OQ/PQ activities, ensuring that operators follow the protocol and that the documentation is accurate and complete.
Regulatory Affairs: Ensures that the documentation complies with regulatory standards and guidelines applicable to IQ/OQ/PQ activities.

4) Procedure

The following steps should be followed for documenting IQ, OQ, and PQ activities:

1. Protocol Preparation:
1.1 Develop IQ, OQ, and PQ protocols for the equipment, system, or process being qualified. The protocols should include the following components:
– A detailed description of the equipment or system to be qualified, including its components and functions.
– The objectives of the qualification (e.g., confirming equipment installation, ensuring operational reliability, verifying performance under normal operating conditions).
– The methodology and procedures to be followed for each qualification activity (IQ, OQ, PQ).
– The acceptance criteria for each test or parameter to be qualified (e.g., temperature, pressure, cycle time).
– The roles and responsibilities of personnel involved in the qualification process.
– A schedule for performing IQ/OQ/PQ activities and completing documentation.
1.2 Ensure that the protocols are reviewed and approved by relevant stakeholders (QA, regulatory affairs, production management) before the qualification activities begin.
1.3 Any changes or deviations from the approved protocols must be documented and reviewed according to the change control process.

2. Data Collection and Documentation:
2.1 During IQ, OQ, and PQ activities, ensure that all data is accurately recorded, including environmental conditions, test parameters, observations, and results.
2.2 For each IQ/OQ/PQ activity, the following information must be documented:
– Date and time of the activity
– Equipment and system identification (e.g., equipment serial numbers, batch numbers)
– The operator or technician performing the activity
– The specific test or qualification procedure being conducted
– The results of each test, including any deviations from expected results
2.3 Ensure that all documentation is signed and dated by the responsible personnel (e.g., operators, validation team, QA). Each entry should be legible and accurate, with any corrections clearly indicated and initialed.
2.4 Document any deviations from the qualification protocol and investigate the root causes. Record the corrective actions taken to resolve these deviations and ensure the system or equipment meets the required specifications.
2.5 Maintain proper version control for all documents, including the protocols and records, to ensure that the most up-to-date versions are used and archived.

3. Report Preparation:
3.1 Prepare the IQ, OQ, and PQ reports based on the collected data and results. The reports should include the following sections:
– Introduction: Overview of the qualification activity, including the purpose, scope, and objectives of the IQ/OQ/PQ.
– Test Results: Detailed documentation of the test results, including all data collected and a comparison of the results against the acceptance criteria.
– Deviations: Any deviations from the qualification protocol should be documented, including a description of the deviation, its cause, and corrective actions taken.
– Conclusion: A summary of the findings, including whether the equipment or system passed the qualification and meets the required specifications.
– Sign-off: Signatures from all relevant personnel, including the validation team, operators, QA, and other stakeholders involved in the qualification.
3.2 Submit the IQ/OQ/PQ reports for review and approval by the appropriate personnel (e.g., QA, regulatory affairs, production management). The reports should be approved before the system or equipment is put into operation.
3.3 Any discrepancies or issues identified during the review process should be addressed, and corrective actions should be documented and implemented.

4. Archiving and Retention:
4.1 Ensure that all IQ/OQ/PQ documentation, including protocols, test data, and reports, is properly archived in a secure and organized manner.
4.2 Retain all documentation for the required period as specified by regulatory requirements, internal policies, or contractual obligations.
4.3 Ensure that archived documents are protected from damage or loss and are readily accessible for inspection during audits or regulatory inspections.
4.4 Implement a process for retrieving archived documents and reviewing historical IQ/OQ/PQ records during requalification activities or for future audits.

5) Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice

6) Documents

• IQ/OQ/PQ Protocol
• IQ/OQ/PQ Report
• Test Data and Results
• Deviation and Corrective Action Reports
• Approval Forms
• Archiving and Retention Records

7) Reference

• FDA Guidance for Industry: Process Validation
• International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• ISO 9001: Quality Management Systems – Requirements
• USP Chapter 1072: Cleaning and Sanitization of Manufacturing Equipment

8) SOP Version

Version 1.0 – Effective Date: DD/MM/YYYY

Annexure

Template 1: IQ/OQ/PQ Protocol Template

Template 2: IQ/OQ/PQ Report Template

Template 3: Deviation Report Template