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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.
Jul 25, 2024 · A manufacturing SOP (Standard Operating Procedure) is a set of documented step-by-step work instructions designed to guide workers in performing manufacturing tasks. Manufacturing SOPs helps promote work consistency, prevent loss of quality, and retain brand reputation.
- In an ideal scenario, a manufacturing company would have a dedicated team for creating their SOPs. But in reality, one person–typically the process...
- SOPs in manufacturing come in two types: technical and management SOPs. A technical SOP shows workers how to carry out and complete specific tasks...
- Depending on the purpose and depth of the plan, manufacturing SOPs may come in the following forms: Hierarchical steps – indicate multiple steps fo...
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 studies); and master formulae (manufacturing instructions).
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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- 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.
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.
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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:
