The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure for Tablet Press Operation and Changeover Purpose: The purpose of this SOP is to establish guidelines for the safe and efficient operation and changeover of tablet press machines within the tablet manufacturing department. This SOP aims to ensure product quality, minimize downtime, and promote compliance with regulatory requirements and Good Manufacturing Practices (GMP)….
Standard Operating Procedure (SOP) for Regulatory Laboratory Controls and Testing Purpose: The purpose of this SOP is to establish the procedures for regulatory laboratory controls and testing to ensure compliance with applicable regulations and standards. It defines the processes for laboratory testing, documentation, equipment calibration and maintenance, sample handling, and reporting of test results. Effective…
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Standard Operating Procedure (SOP) for Regulatory Supplier Qualification and Management Purpose: The purpose of this SOP is to outline the process and requirements for the qualification and management of suppliers in regulatory affairs. It ensures that suppliers meet the necessary criteria for providing goods or services that are critical to regulatory activities. Effective supplier qualification…
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Standard Operating Procedure (SOP) for Regulatory Data Integrity Purpose: The purpose of this SOP is to establish guidelines and procedures to ensure data integrity in regulatory activities. It aims to prevent unauthorized access, loss, alteration, or falsification of data throughout the regulatory processes, including data generation, collection, analysis, and reporting. Adherence to data integrity principles…
Standard Operating Procedure (SOP) for Regulatory Good Distribution Practices (GDP) Purpose: The purpose of this SOP is to establish guidelines and procedures for ensuring compliance with Good Distribution Practices (GDP) for pharmaceutical products. The SOP aims to maintain the integrity, quality, and safety of distributed products throughout the supply chain, from storage to transportation and…
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Standard Operating Procedure (SOP) for Regulatory Annual Product Quality Review Purpose: The purpose of this SOP is to establish a systematic process for conducting annual product quality reviews (APQRs) to assess the overall quality performance of regulated products. The APQRs provide a comprehensive evaluation of product quality and ensure ongoing compliance with regulatory requirements. Scope:…
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Standard Operating Procedure (SOP) for Regulatory Advertising and Promotional Material Review Purpose: The purpose of this SOP is to establish a systematic and compliant process for the review and approval of advertising and promotional materials related to regulated products. The SOP ensures adherence to applicable regulatory requirements, protects the integrity of product claims, and maintains…
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Standard Operating Procedure (SOP) for Regulatory Electronic Document Management Systems Purpose: The purpose of this SOP is to establish guidelines for the efficient and effective management of regulatory electronic documents within the organization. The SOP aims to ensure compliance with regulatory requirements, facilitate document control and versioning, and promote accessibility and traceability of electronic documents…
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Standard Operating Procedure (SOP) for Regulatory Patent and Intellectual Property Management Purpose: The purpose of this SOP is to establish a standardized process for managing regulatory patents and intellectual property (IP) within the organization. The SOP aims to ensure compliance with IP laws and regulations, protect the organization’s inventions and innovations, and facilitate effective IP…
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Standard Operating Procedure (SOP) for Regulatory Due Diligence Purpose: The purpose of this SOP is to establish a standardized process for conducting regulatory due diligence in the context of business transactions, such as mergers, acquisitions, partnerships, or licensing agreements. The regulatory due diligence aims to identify and assess potential regulatory risks, compliance issues, and any…