Standard Operating Procedure for In-Process Control During Manufacturing
1) Purpose
The purpose of this SOP is to establish procedures for conducting in-process controls during the manufacturing of dental dosage forms to ensure product quality and compliance with regulatory standards.
2) Scope
This SOP applies to all stages of manufacturing processes involving dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Production Department is responsible for conducting in-process controls. The Quality Assurance (QA) Department is responsible for verifying compliance with this SOP.
4) Procedure
4.1 Sampling Plan
4.1.1 Develop a sampling plan based on manufacturing process steps, critical control points, and regulatory requirements.
4.1.2 Determine sampling points, frequency, and sample sizes based on risk assessment and process validation data.
4.2 Sampling Process
4.2.1 Wear appropriate personal protective equipment (PPE) and follow aseptic techniques during sampling.
4.2.2 Collect samples according to defined sampling procedures and transfer them to the laboratory for analysis.
4.3 Analysis and Testing
4.3.1 Perform physical, chemical, and microbiological tests on in-process samples as per approved test methods and specifications.
4.3.2 Record test results and compare them against acceptance criteria defined in batch records and standard operating procedures.
4.4 Documentation
4.4.1 Document all in-process control activities, including sampling, testing, and results recording.
4.4.2 Maintain batch records and in-process control records throughout the manufacturing process.
4.5 Deviation Management
4.5.1 Identify and investigate any deviations from established procedures or acceptance criteria.
4.5.2 Initiate corrective and preventive actions (CAPA) as necessary to address deviations.
4.6 Release or Rejection Decision
4.6.1 Review in-process control data and test results to make decisions regarding product release or rejection.
4.6.2 Document release decisions and reasons for rejection in batch records.
5) Abbreviations, if any
QA – Quality Assurance
PPE – Personal Protective Equipment
6) Documents, if any
In-Process Control Records
Batch Records
Test Method Validation Reports
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0
