The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Managing Device Master Records (DMR) Comprehensive Guide to Managing Device Master Records (DMR) in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized approach to creating, maintaining, and managing Device Master Records (DMR) for medical devices. The DMR is a comprehensive document that defines the specifications, production…
SOP for Final Quality Inspection of Medical Devices Comprehensive Guide to Final Quality Inspection of Medical Devices 1) Purpose The purpose of this SOP is to define a standardized procedure for conducting final quality inspections on medical devices before their release for distribution. This ensures that the devices meet the required quality, safety, and performance…
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SOP for In-Process Quality Control Checks Comprehensive Guide to In-Process Quality Control Checks in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a systematic procedure for performing in-process quality control (IPQC) checks during the manufacturing of medical devices. These checks ensure that products meet specified standards and regulatory requirements at…
SOP for Quality Control Testing of Raw Materials Comprehensive Guide to Quality Control Testing of Raw Materials in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for testing raw materials used in medical device manufacturing. This ensures that all materials meet the required specifications, quality standards, and…
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SOP for Disposal of Rejected or Scrap Materials Comprehensive Guide to Disposal of Rejected or Scrap Materials in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to define the procedures for handling, documenting, and disposing of rejected or scrap materials in medical device manufacturing. This ensures compliance with environmental regulations, prevents unauthorized…
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SOP for Handling Non-Conforming Products in Manufacturing Comprehensive Guide to Handling Non-Conforming Products in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for identifying, documenting, and handling non-conforming products in the manufacturing process. This ensures that all non-conforming products are managed in a way that maintains compliance…
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SOP for Tool and Die Maintenance in Medical Device Manufacturing Comprehensive Guide to Tool and Die Maintenance in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to define the procedures for maintaining tools and dies used in medical device manufacturing. Proper maintenance ensures precision, prolongs the lifespan of tools and dies, and…
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SOP for Production Planning and Scheduling Comprehensive Guide to Production Planning and Scheduling in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a structured approach to production planning and scheduling in medical device manufacturing. This ensures optimal resource utilization, timely delivery of products, compliance with regulatory standards, and alignment with…
SOP for Identifying and Mitigating Manufacturing Risks Comprehensive Guide to Identifying and Mitigating Manufacturing Risks in Medical Device Production 1) Purpose The purpose of this SOP is to outline a systematic approach for identifying, assessing, and mitigating risks in the manufacturing process of medical devices. This ensures compliance with regulatory standards, maintains product quality, and…
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SOP for Machine Maintenance and Troubleshooting Comprehensive Guide to Machine Maintenance and Troubleshooting in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for maintaining and troubleshooting machines used in the production of medical devices. Proper maintenance ensures equipment reliability, minimizes downtime, and guarantees that devices are manufactured…
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