The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure for Sealing Integrity Check Purpose The purpose of this SOP is to establish procedures for the systematic and thorough checking of sealing integrity in pharmaceutical packaging, ensuring compliance with regulatory standards and maintaining product quality. Scope This SOP applies to all personnel involved in the manufacturing and quality control of pharmaceutical products, specifically…
Standard Operating Procedure for Data Integrity Risk Assessment Purpose The purpose of this SOP is to establish procedures for conducting systematic data integrity risk assessments within the pharmaceutical manufacturing facility. This process helps identify, evaluate, and mitigate potential risks to data integrity throughout the data lifecycle. Scope This SOP applies to all personnel involved in data…
Standard Operating Procedure for Documentation and Record-Keeping Purpose The purpose of this SOP is to establish procedures for the systematic and accurate documentation and record-keeping in pharmaceutical manufacturing, ensuring compliance with regulatory standards and maintaining data integrity. Scope This SOP applies to all personnel involved in the manufacturing and quality control of pharmaceutical products, including operators,…
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Standard Operating Procedure Vendor Data Integrity Purpose The purpose of this SOP is to establish procedures for ensuring the integrity of data received from vendors within the pharmaceutical manufacturing facility. This includes data related to raw materials, components, and services supplied by external vendors. Scope This SOP applies to all personnel involved in the procurement,…
Standard Operating Procedure for Sampling and Retention of Samples Purpose The purpose of this SOP is to establish procedures for the systematic and accurate sampling of raw materials, in-process materials, and finished products, as well as the retention of representative samples for further analysis and future reference. Scope This SOP applies to all personnel involved in…
Standard Operating Procedure for Vacuum Conveyor Operation Purpose The purpose of this SOP is to establish procedures for the safe and efficient operation of the vacuum conveyor system, ensuring proper material handling, cleanliness, and compliance with regulatory standards. Scope This SOP applies to all personnel involved in the operation and maintenance of the vacuum conveyor,…
Standard Operating Procedure for Data Integrity Training Program Purpose The purpose of this SOP is to establish procedures for the implementation and management of a Data Integrity Training Program within the pharmaceutical manufacturing facility. This program aims to educate personnel on the principles of data integrity, regulatory requirements, and best practices to ensure the accuracy and…
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Standard Operating Procedure for Inkjet or Laser Coding Process Purpose The purpose of this SOP is to establish procedures for the accurate and consistent coding of pharmaceutical products using inkjet or laser coding technology, ensuring compliance with regulatory standards and product traceability. Scope This SOP applies to all personnel involved in the inkjet or laser…
Standard Operating Procedure for Coating Process Purpose The purpose of this SOP is to establish procedures for the coating of pharmaceutical products, ensuring consistency, quality, and compliance with regulatory standards. Scope This SOP applies to all personnel involved in the coating process, including operators, technicians, and quality control personnel. Responsibilities Operators: Responsible for executing the coating…
Standard Operating Procedure for Data Quality Metrics Purpose The purpose of this SOP is to establish procedures for the systematic measurement and assessment of data quality within the pharmaceutical manufacturing facility. This ensures the accuracy, completeness, and reliability of electronic data used for decision-making and regulatory compliance. Scope This SOP applies to all personnel involved in…