Standard Operating Procedure for Sampling Procedures for Quality Control
1) Purpose
The purpose of this SOP is to establish procedures for the sampling of raw materials, intermediate products, and finished products during the manufacturing of dental dosage forms to ensure compliance with quality specifications and regulatory requirements.
2) Scope
This SOP applies to all sampling activities conducted for quality control purposes in the production of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Quality Control (QC) Department is responsible for executing sampling procedures. The Quality Assurance (QA) Department is responsible for verifying compliance with this SOP.
4) Procedure
4.1 Sampling Plan Development
4.1.1 Develop sampling plans based on regulatory requirements, product specifications, and risk assessment.
4.1.2 Determine sampling points, frequencies, and sample sizes for raw materials, intermediate products, and finished products.
4.2 Sample Collection
4.2.1 Follow standard operating procedures for sample collection, including sampling techniques and equipment.
4.2.2 Collect representative samples ensuring proper identification and labeling.
4.3 Sample Handling and Preparation
4.3.1 Handle samples with care to prevent contamination or degradation.
4.3.2 Prepare samples according to specified procedures for further testing or analysis.
4.4 Testing and Analysis
4.4.1 Perform testing and analysis of samples using approved methods and equipment.
4.4.2 Record test results accurately and compare against established acceptance criteria.
4.5 Disposition and Documentation
4.5.1 Dispose of samples appropriately after testing, following waste management procedures.
4.5.2 Document all sampling activities, including sampling plans, collection details, testing results, and disposition.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QC – Quality Control
6) Documents, if any
Sampling Plans
Sample Collection Records
Testing Reports
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
Pharmacopeial standards (e.g., USP, EP)
8) SOP Version
Version 1.0
