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This guidance document, Guidance for Preparing Standard Operating Procedures (SOPs) provides a standard working tool that can be used to document routine quality system management and technical activities.
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4.1 Standard operating procedures, specifications and master formulae. Descriptive documents give instructions on how to perform a procedure or a study, or give a description of specifications. The instruction type documents are: standard operating procedures (SOP); protocols (for validation studies, stability studies, safety
- Quality Assurance (QA) Management Procedures. Writing Standard Operating Procedure. Standard Operating Procedures (SOPs) are issued to specifically instruct employees in areas of responsibility, Work Instructions, appropriate specifications, and required records.
- Quality Control Laboratory Procedures. Retest Dating. The period of time following analysis that a material can be used prior to retesting and the setting of a new retest date, providing the material has been stored under appropriate conditions.
- Microbiology (Sterility) Laboratory Procedures. Sterile Entry. Carefully roll down the leg part of the overshoe, exposing the inside while you are still wearing gloves.
- Process, Cleaning and Methodology Validation Procedures. Concept and Procedure of Validation. Validation is the process of establishing a high degree of assurance that a specific process, activity, or system will consistently and reliably produce a product meeting predetermined specifications and quality characteristics.
Standard Operating Procedures (SOPs) are issued to specifically instruct employees in areas of responsibility, Work Instructions, appropriate specifications and required records. SOPs outline procedures, which must be followed to claim compliance with GMP
The Guide presents a review of the types and extent of validations required by GMP, the preparation of a Master Validation Plan, formats for the equipment and systems qualifications and process and analytical assay validation protocols, and examples of the typical requirements for various validation studies.
A standard operating procedure, or SOP, provides a set of step-by-step instructions compiled by experts at an organization to help workers implement complex routine operations. SOPs can be written for processes that an individual or group perform in many situations:
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Jun 6, 2024 · Structure your GMP SOPs with defined sections, including purpose, scope, definitions, procedure, responsibilities, and documentation, ensuring each step is specific and logically ordered. Incorporate visual aids like flowcharts and diagrams judiciously to clarify complex processes.
