The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Process Validation Standard Operating Procedure for Process Validation 1) Purpose The purpose of this SOP is to outline the procedures for validating manufacturing processes to ensure they consistently produce products meeting predetermined quality attributes. 2) Scope This SOP applies to all manufacturing processes within the facility that require validation, including new processes, changes…
SOP for Metered Dose Inhaler (MDI) Performance Testing Procedure for Metered Dose Inhaler (MDI) Performance Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing the performance of metered dose inhalers (MDIs) used for administering pharmaceutical products to ensure proper functionality and dose accuracy. 2) Scope This SOP applies to…
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SOP for Training and Competency Assessment Standard Operating Procedure for Training and Competency Assessment 1) Purpose This SOP outlines the procedures for identifying training needs, conducting training programs, assessing competency, and maintaining records to ensure that all personnel are adequately trained and competent to perform their assigned tasks in compliance with regulatory requirements. 2) Scope…
SOP for Emergency Purchase Procedure Emergency Purchase Procedure – Standard Operating Procedure 1) Purpose To establish guidelines for handling emergency procurement situations to ensure timely acquisition of critical materials or services within the pharmaceutical purchase department. 2) Scope This SOP applies to emergency procurement situations that require immediate action to mitigate operational disruptions or safety…
SOP for Nasal Spray Pump Performance Testing Procedure for Nasal Spray Pump Performance Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing the performance of nasal spray pumps used for administering pharmaceutical products to ensure proper functionality and dosage accuracy. 2) Scope This SOP applies to all nasal spray…
SOP for Good Documentation Practices (GDP) Standard Operating Procedure for Good Documentation Practices (GDP) 1) Purpose This SOP outlines the principles and guidelines for maintaining accurate, complete, and traceable documentation throughout all stages of pharmaceutical manufacturing, ensuring data integrity, compliance with regulatory requirements, and support for quality assurance activities. 2) Scope This SOP applies to…
SOP for Autoinjector Functionality Testing Procedure for Autoinjector Functionality Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing the functionality of autoinjectors used for administering pharmaceutical products to ensure proper operation and safety. 2) Scope This SOP applies to all autoinjectors used for administering pharmaceutical products, requiring testing to…
SOP for Stability Testing of IV Injections Standard Operating Procedure for Stability Testing of Intravenous (IV) Injections 1) Purpose The purpose of this SOP is to establish a standardized procedure for conducting stability testing of intravenous (IV) injections to ensure their safety, efficacy, and quality throughout the product’s shelf life. 2) Scope This SOP applies…
SOP for Procurement of Manufacturing Equipment Procurement of Manufacturing Equipment – Standard Operating Procedure 1) Purpose To establish guidelines for procuring manufacturing equipment to ensure compliance, efficiency, and reliability in production processes within the pharmaceutical purchase department. 2) Scope This SOP applies to the procurement of manufacturing equipment used in pharmaceutical production facilities. 3) Responsibilities…
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SOP for Documentation Control Standard Operating Procedure for Documentation Control 1) Purpose This SOP outlines the procedures for the creation, review, approval, distribution, and maintenance of documents to ensure consistency, accuracy, accessibility, and compliance with regulatory requirements. 2) Scope This SOP applies to all departments and personnel involved in creating, reviewing, approving, distributing, and maintaining…