The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Maintenance of Production Equipment Standard Operating Procedure for Maintenance of Production Equipment 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of production equipment to ensure optimal performance and reliability in the pharmaceutical manufacturing process. 2) Scope This SOP applies to all production equipment used in…
SOP for Product Release Testing for Gels Standard Operating Procedure for Product Release Testing for Gels 1) Purpose The purpose of this SOP is to establish procedures for conducting product release testing on gels to ensure they meet predefined quality specifications before release for distribution and use. 2) Scope This SOP applies to the Quality…
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SOP for Handling and Storage of Procured Goods Handling and Storage of Procured Goods – Standard Operating Procedure 1) Purpose To establish a standardized process for the proper handling and storage of procured goods to ensure their quality, safety, and compliance with regulatory requirements within the pharmaceutical purchase department. 2) Scope This SOP applies to…
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SOP for Light Exposure Testing for Gels Standard Operating Procedure for Light Exposure Testing for Gels 1) Purpose The purpose of this SOP is to define procedures for conducting light exposure testing on gels to evaluate their stability under light exposure conditions, ensuring product quality and compliance with regulatory requirements. 2) Scope This SOP applies…
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SOP for Batch Reconciliation in Gels Production Standard Operating Procedure for Batch Reconciliation in Gels Production 1) Purpose The purpose of this SOP is to define the process for accurately reconciling raw materials, intermediates, and final product quantities for each batch of gel produced, ensuring compliance with regulatory requirements and minimizing discrepancies. 2) Scope This…
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SOP for Freeze-Thaw Stability Testing for Gels Standard Operating Procedure for Freeze-Thaw Stability Testing for Gels 1) Purpose The purpose of this SOP is to establish procedures for conducting freeze-thaw stability testing on gels to assess their ability to withstand freezing and thawing cycles, ensuring product integrity and quality. 2) Scope This SOP applies to…
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SOP for Temperature Cycling Testing for Gels Standard Operating Procedure for Temperature Cycling Testing for Gels 1) Purpose The purpose of this SOP is to define procedures for conducting temperature cycling testing on gels to evaluate their stability under varying temperature conditions, ensuring product quality and compliance with regulatory requirements. 2) Scope This SOP applies…
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SOP for Batch Manufacturing Record for Gels Standard Operating Procedure for Batch Manufacturing Record for Gels 1) Purpose The purpose of this SOP is to outline the procedures for creating, maintaining, and reviewing Batch Manufacturing Records (BMR) for gels to ensure accurate documentation and traceability of each production batch. 2) Scope This SOP applies to…
SOP for Compatibility Testing of Gels with Packaging Materials Standard Operating Procedure for Compatibility Testing of Gels with Packaging Materials 1) Purpose The purpose of this SOP is to establish procedures for conducting compatibility testing of gels with packaging materials to ensure product stability, safety, and quality throughout the shelf life. 2) Scope This SOP…
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SOP for Batch Documentation for FFS Operations Standard Operating Procedure for Batch Documentation for FFS Operations 1) Purpose The purpose of this SOP is to establish guidelines for the preparation, review, and maintenance of batch documentation related to Form-Fill-Seal (FFS) operations in pharmaceutical manufacturing. 2) Scope This SOP applies to all batch documentation activities for…
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