Standard Operating Procedure for Analytical Method Development for Lotions
1) Purpose
The purpose of this SOP is to establish procedures for the development and validation of analytical methods used to assess the quality and characteristics of lotions during manufacturing.
2) Scope
This SOP applies to all personnel involved in the development, validation, and implementation of analytical methods for lotions within the pharmaceutical manufacturing facility.
3) Responsibilities
The responsibilities for executing this SOP are as follows:
Analytical Chemists:
- Design and develop analytical methods for assessing lotion attributes and quality parameters.
- Perform method validation studies and ensure methods are robust and reliable.
Quality Assurance (QA) Personnel:
- Review and approve analytical method development protocols and validation reports.
- Verify compliance with SOPs, pharmacopeial standards, and regulatory requirements.
Quality Control (QC) Analysts:
- Implement validated analytical methods for routine testing and monitoring of lotion samples.
- Record and report analytical results accurately and promptly.
4) Procedure
4.1 Method Development:
- Define analytical requirements and objectives based on lotion characteristics and quality attributes.
- Select suitable analytical techniques, instruments, and reagents for method development.
4.2 Method Optimization:
- Optimize analytical parameters such as wavelength, temperature, and sample preparation techniques.
- Conduct feasibility studies and preliminary testing to refine method performance.
4.3 Method Validation:
- Validate developed methods according to predefined protocols and acceptance criteria.
- Perform validation studies for specificity, accuracy, precision, linearity, and robustness.
4.4 Documentation and Reporting:
- Document method development and validation activities, including experimental protocols, data analysis, and conclusions.
- Prepare comprehensive reports summarizing method validation results and conclusions.
4.5 Method Transfer and Implementation:
- Transfer validated methods to routine QC laboratories and ensure training of personnel on method execution.
- Monitor method performance during routine use and conduct periodic method reviews.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
6) Documents, if any
- Analytical Method Development Protocols
- Method Validation Reports
- Method Transfer Documentation
7) Reference, if any
- ICH Q2 (R1): Validation of Analytical Procedures
- USP <1225>: Validation of Compendial Procedures
8) SOP Version
Version 1.0
