Standard Operating Procedure for Validation of Automated Systems
1) Purpose
The purpose of this SOP is to establish procedures for the validation of automated systems used in the manufacturing of dental dosage forms, including pastes, gels, and mouthwashes. The goal is to ensure that automated systems operate consistently and reliably to meet predefined specifications and regulatory requirements.
2) Scope
This SOP applies to all automated systems used in pharmaceutical manufacturing processes for dental dosage forms. It includes procedures for qualification, validation, and ongoing monitoring of automated systems to ensure compliance with Good Automated Manufacturing Practice (GAMP) guidelines.
3) Responsibilities
The Engineering and Validation Departments are responsible for planning and executing the validation activities of automated systems. The Quality Assurance (QA) Department is responsible for oversight, review, and approval of validation protocols and reports. All personnel involved in the operation and maintenance of automated systems are responsible for adhering to validation procedures and reporting any deviations promptly.
4) Procedure
4.1 Planning and Preparation
4.1.1 Identify automated systems requiring validation based on their criticality to product quality, safety, and regulatory compliance.
4.1.2 Develop a validation master plan (VMP) outlining the approach, scope, and resources required for the validation of each automated system.
4.1.3 Define user requirements specifications (URS)
4.2 Installation Qualification (IQ)
4.2.1 Verify that the automated system is installed correctly according to manufacturer’s specifications and regulatory requirements.
4.2.2 Document and review installation qualification protocols (IQP) to ensure compliance with predefined acceptance criteria.
4.2.3 Obtain approval for IQ protocols and proceed with execution once installation is completed.
4.3 Operational Qualification (OQ)
4.3.1 Test and verify that the automated system operates according to predefined operational parameters and performance specifications.
4.3.2 Develop operational qualification protocols (OQP) to validate critical functions, alarms, and interlocks of the automated system.
4.3.3 Execute OQ protocols, collect data, and analyze results to demonstrate compliance with acceptance criteria.
4.4 Performance Qualification (PQ)
4.4.1 Conduct performance qualification to confirm that the automated system consistently produces results within specified operational limits under actual production conditions.
4.4.2 Develop performance qualification protocols (PQP) based on worst-case scenarios and critical process parameters.
4.4.3 Execute PQ protocols, monitor system performance, collect data, and evaluate results against acceptance criteria.
4.5 Validation Summary Report
4.5.1 Compile all validation documentation, including IQ, OQ, and PQ protocols, executed test records, and deviation reports.
4.5.2 Prepare a validation summary report summarizing the validation approach, results, conclusions, and any deviations encountered during the validation process.
4.5.3 Review and approve the validation summary report by relevant stakeholders, including QA, engineering, and management.
5) Abbreviations, if any
SOP – Standard Operating Procedure
IQ – Installation Qualification
OQ – Operational Qualification
PQ – Performance Qualification
URS – User Requirements Specifications
VMP – Validation Master Plan
6) Documents, if any
Validation Master Plan (VMP)
Installation Qualification Protocol (IQP)
Operational Qualification Protocol (OQP)
Performance Qualification Protocol (PQP)
Validation Summary Report
7) Reference, if any
Good Automated Manufacturing Practice (GAMP) guidelines
Manufacturer’s recommendations for automated system validation
Regulatory guidelines for validation of automated systems in pharmaceutical manufacturing
8) SOP Version
Version 1.0