Standard Operating Procedure
A Standard Operating Procedure (SOP) is an authorized, written set of instructions for specific laboratory operations. It ensures that tests are carried out consistently and safely, so the results can be trusted and verified.
Also called: SOP, Standard Operating Procedures, SOPs
A Standard Operating Procedure (SOP) is an official, documented instruction set for laboratory work that controls how tests are performed rather than measuring a chemical property itself. These written procedures ensure that analytical techniques, such as Mass Spectrometry or HPLC, are executed with accuracy, safety, and consistency.
SOPs guide laboratory testing and documentation
SOPs provide the necessary framework for analytical testing and documentation to ensure that lab reports and Certificates of Analysis (CoA) meet competence requirements such as ISO/IEC 17025:2017. By standardizing every action, these procedures support accuracy, safety, and consistency across all laboratory operations.
When you evaluate a CoA, the underlying SOP is vital for traceability. It ensures that the report can be independently verified against published standards. For example, an SOP may specify shallow gradients during HPLC so impurities are not hidden, while requiring analysts to document their name, signature, and the date for each step performed.
SOP, analytical method, and CoA have different roles
- Standard Operating Procedure (SOP): The official written instruction document that defines the testing and documentation process.
- Analytical Method: The actual testing technique being performed, such as GC-MS or ICP-MS.
- Certificate of Analysis (CoA): The final report issued by the laboratory that contains the actual test results.
Sources
- [PDF] Analytical Procedures and Methods Validation for Drugs and Biologics
- STANDARD OPERATING PROCEDURE FORMS - Chemical Laboratory Safety and Security - NCBI Bookshelf
- [PDF] Regulatory Testing Laboratory Manual of Quality Policies - FDA
- [PDF] Methods, Method Verification and Validation (ORA- LAB.5.4.5) - FDA
- FDA Sets Peptide Impurity Thresholds as Low as 0.10%, Oath ...
- What Are the FDA Requirements for Peptide Characterization? -
- Recommendations for the generation, quantification, storage ...
- Q2(R1) Validation of Analytical Procedures: Text and Methodology
- [PDF] fda laboratory accreditation for analyses of foods (laaf) program
- Laboratory Manual of Quality Policies (ISO 17025 Requirements) | FDA
- Annex 4
- [PDF] Q 2 (R1) Validation of Analytical Procedures: Text and Methodology
- Annex 1 WHO good practices for pharmaceutical quality control laboratories
- Annex 4
- Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients | FDA
- HPLC Analysis and Purification of Peptides