The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Inventory Management Inventory Management – Standard Operating Procedure 1) Purpose To establish a standardized process for managing inventory levels effectively, ensuring adequate stock availability while minimizing excess inventory within the pharmaceutical purchase department. 2) Scope This SOP applies to all inventory management activities, including stock monitoring, replenishment, storage, and inventory record-keeping. 3) Responsibilities…
SOP for Maintenance of Fume Hoods and Laminar Flow Hoods Standard Operating Procedure for Maintenance of Fume Hoods and Laminar Flow Hoods 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of fume hoods and laminar flow hoods to ensure safe and effective containment of hazardous substances in…
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SOP for Recall Procedure for Gels Standard Operating Procedure for Recall Procedure for Gels 1) Purpose The purpose of this SOP is to establish procedures for the initiation, execution, and documentation of product recalls for gels to promptly remove products from the market that pose a risk to public health or do not meet quality…
SOP for Good Manufacturing Practices (GMP) Compliance Standard Operating Procedure for Good Manufacturing Practices (GMP) Compliance 1) Purpose This SOP outlines the procedures for ensuring compliance with Good Manufacturing Practices (GMP) to consistently produce pharmaceutical products that meet quality and regulatory requirements. 2) Scope This SOP applies to all personnel involved in the manufacturing, packaging,…
SOP for Post-Market Surveillance for Gels Standard Operating Procedure for Post-Market Surveillance for Gels 1) Purpose The purpose of this SOP is to establish procedures for conducting post-market surveillance (PMS) activities for gels to monitor their safety, efficacy, and performance in real-world use, and to ensure compliance with regulatory requirements. 2) Scope This SOP applies…
SOP for Regulatory Submission for Gels Standard Operating Procedure for Regulatory Submission for Gels 1) Purpose The purpose of this SOP is to establish procedures for the preparation, compilation, and submission of regulatory documents related to gels to regulatory authorities, ensuring compliance with applicable laws, regulations, and guidelines. 2) Scope This SOP applies to all…
SOP for Maintenance of Dehumidifiers Standard Operating Procedure for Maintenance of Dehumidifiers 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of dehumidifiers to ensure optimal humidity control in pharmaceutical manufacturing and storage areas. 2) Scope This SOP applies to all dehumidifiers used in pharmaceutical manufacturing facilities, laboratories,…
SOP for Quality Control Testing of IV Injections Standard Operating Procedure for Quality Control Testing of IV Injections 1) Purpose The purpose of this SOP is to define the procedures for conducting quality control testing of intravenous (IV) injections to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies to all quality…
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SOP for Clinical Trial Material Production for Gels Standard Operating Procedure for Clinical Trial Material Production for Gels 1) Purpose The purpose of this SOP is to establish procedures for the production of clinical trial materials (CTMs) for gels used in clinical trials, ensuring that materials are manufactured, labeled, stored, and distributed in compliance with…
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SOP for Purchase Return Process Purchase Return Process – Standard Operating Procedure 1) Purpose To establish a standardized procedure for managing the return of purchased goods that are defective, damaged, or otherwise unacceptable, ensuring compliance with contractual agreements and regulatory requirements within the pharmaceutical purchase department. 2) Scope This SOP applies to all returns of…