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    • 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.
  1. This procedure provides a guideline on how to write a Standard Operating Procedure \(SOP\), including how to format the document. The Purpose of a SOP is to provide detailed instructions on how to carry out a task so that any employee can carry out a ta\ sk correctly every time.

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  2. This SOP defines the approach to Quality Risk Management (QRM) of a GMP site and gives practical examples for tools which may be used to facilitate the process and to aid personnel performing the assessment.

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  3. 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. 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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  5. Use this free Standard Operating Procedure Template for Word to manage your projects better. Download Word File. A standard operating procedure (SOP) is a set of instructions that direct an organization or project team on how to do a task. It’s a step-by-step guide similar to the assembly instructions found inside many products one might ...

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  7. 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