Standard Operating Procedure for Process Control and Monitoring
1) Purpose
The purpose of this SOP is to establish procedures for the control, monitoring, and documentation of manufacturing processes for dental dosage forms, ensuring consistency, quality, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the production, testing, and control of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
Production supervisors and quality assurance personnel are responsible for implementing and overseeing process control and monitoring activities. Operators and technicians are responsible for executing processes in accordance with documented procedures.
4) Procedure
4.1 Process Parameters and Specifications
4.1.1 Define critical process parameters (CPPs) and their acceptable ranges based on product specifications and regulatory requirements.
4.1.2 Establish process controls to ensure that CPPs are monitored and maintained within specified limits during production.
4.2 In-Process Monitoring
4.2.1 Conduct real-time monitoring of CPPs using calibrated instruments and automated systems.
4.2.2 Document in-process data at defined intervals or stages of production to ensure traceability and compliance.
4.3 Process Adjustments and Interventions
4.3.1 Implement timely adjustments or interventions to maintain process parameters within acceptable limits, following predefined procedures and authorization protocols.
4.3.2 Record all adjustments, deviations, and corrective actions taken during the production process.
4.4 Sampling and Testing
4.4.1 Perform scheduled sampling of in-process materials for quality control testing, ensuring that samples are representative of the batch.
4.4.2 Conduct testing using validated methods and equipment to verify product quality and compliance with specifications.
4.5 Documentation and Record-Keeping
4.5.1 Maintain accurate and complete records of process parameters, in-process monitoring data, adjustments, and testing results.
4.5.2 Ensure that all documentation is reviewed, approved, and stored in accordance with Good Documentation Practices (GDP).
5) Abbreviations, if any
SOP – Standard Operating Procedure
CPP – Critical Process Parameter
GDP – Good Documentation Practices
6) Documents, if any
Process Flow Diagrams
Batch Records
Quality Control Test Procedures
7) Reference, if any
Current Good Manufacturing Practices (cGMP)
International Conference on Harmonization (ICH) guidelines
8) SOP Version
Version 1.0