Standard Operating Procedure for Process Validation of Paste Manufacturing
1) Purpose
The purpose of this SOP is to define procedures for the validation of the paste manufacturing process used in the production of dental dosage forms, ensuring consistency, reliability, and compliance with regulatory requirements.
2) Scope
This SOP applies to the process validation activities conducted for the manufacturing of dental pastes within the pharmaceutical industry.
3) Responsibilities
The Production Department is responsible for executing process validation activities. The Quality Assurance (QA) Department is responsible for reviewing and approving validation protocols and reports.
4) Procedure
4.1 Process Validation Protocol Development
4.1.1 Develop a process validation protocol outlining validation objectives, acceptance criteria, and testing methods.
4.1.2 Identify critical process parameters (CPPs) and critical quality attributes (CQAs) for paste manufacturing.
4.2 Installation Qualification (IQ)
4.2.1 Perform IQ to verify that manufacturing equipment and utilities are installed correctly and meet specifications.
4.2.2 Document IQ results and any deviations identified during installation.
4.3 Operational Qualification (OQ)
4.3.1 Conduct OQ to ensure that equipment operates according to operational parameters.
4.3.2 Test equipment functionality under normal operating conditions.
4.4 Performance Qualification (PQ)
4.4.1 Execute PQ to demonstrate consistent production of paste that meets predetermined specifications.
4.4.2 Perform PQ using actual production conditions and evaluate process performance.
4.5 Process Monitoring and Control
4.5.1
4.5.2 Implement controls to mitigate risks and maintain process stability.
4.6 Validation Report
4.6.1 Compile validation data and results into a comprehensive validation report.
4.6.2 Document conclusions, deviations, and corrective actions taken during the validation process.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Process Validation Protocol
IQ, OQ, and PQ Reports
Validation Summary Report
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
ICH guidelines for process validation
8) SOP Version
Version 1.0