What is a SOP?
FDA and equivalent international organizations require various routine activities to follow written procedures. Healthcare professionals typically use Standard Operating Procedures (SOPs) to address this.
Labcompliance has developed more than 160 different SOP’s.
The main areas covered by these SOP’s are:
- Management Procedures, for example, as defined in ISO/IEC 17025 standard
- Good Laboratory/Good Manufacturing/Good Clinical Practices
- Qualification and Validation
- Electronic Records Management
- General Laboratory Compliance
- Qualification/Validation in Laboratories
- Qualification/Validation in Manufacturing
- Analytical method validation and system suitability testing
- Computer system validation
- Handling Out-of-Specification situations
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