The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Stability Testing of IM and SC Injections Standard Operating Procedure for Stability Testing of Intramuscular (IM) and Subcutaneous (SC) Injections 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting stability testing of Intramuscular (IM) and Subcutaneous (SC) injections to ensure their safety, efficacy, and quality…
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SOP for Cold Chain Management Standard Operating Procedure for Cold Chain Management 1) Purpose The purpose of this SOP is to establish procedures for maintaining the integrity of temperature-sensitive pharmaceutical products throughout the cold chain distribution and storage process. 2) Scope This SOP applies to all personnel involved in handling, storing, and transporting temperature-sensitive pharmaceutical…
SOP for Lyophilization Process Standard Operating Procedure for Lyophilization Process 1) Purpose The purpose of this SOP is to establish procedures for conducting lyophilization (freeze-drying) of pharmaceutical products to ensure product stability and quality. 2) Scope This SOP applies to all personnel involved in the lyophilization process within the pharmaceutical manufacturing facility. 3) Responsibilities 3.1…
SOP for Continuous Improvement in Manufacturing Operations Standard Operating Procedure for Continuous Improvement in Manufacturing Operations 1) Purpose The purpose of this SOP is to define procedures for identifying, implementing, and monitoring continuous improvement initiatives within the pharmaceutical manufacturing operations to enhance efficiency, quality, and compliance. 2) Scope This SOP applies to all personnel involved…
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SOP for Risk Management in Manufacturing Processes Standard Operating Procedure for Risk Management in Manufacturing Processes 1) Purpose The purpose of this SOP is to establish procedures for identifying, assessing, controlling, and mitigating risks associated with manufacturing processes within the pharmaceutical facility. 2) Scope This SOP applies to all personnel involved in manufacturing operations, quality…
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SOP for Stability Testing of IV Products Standard Operating Procedure for Stability Testing of IV Products 1) Purpose The purpose of this SOP is to define procedures for conducting stability testing on intravenous (IV) products to evaluate their physical, chemical, and microbiological stability under various storage conditions. 2) Scope This SOP applies to all personnel…
SOP for Handling Customer Complaints and Product Recalls Standard Operating Procedure for Handling Customer Complaints and Product Recalls 1) Purpose The purpose of this SOP is to establish procedures for receiving, documenting, investigating, and resolving customer complaints, as well as initiating and managing product recalls effectively within the pharmaceutical manufacturing facility. 2) Scope This SOP…
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SOP for Regulatory Compliance and Documentation Standard Operating Procedure for Regulatory Compliance and Documentation 1) Purpose The purpose of this SOP is to outline procedures for ensuring regulatory compliance through proper documentation practices within the pharmaceutical manufacturing facility. 2) Scope This SOP applies to all personnel involved in the creation, review, approval, and maintenance of…
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SOP for CAPA (Corrective and Preventive Actions) Management Standard Operating Procedure for Corrective and Preventive Actions 1) Purpose The purpose of this SOP is to establish procedures for identifying, documenting, investigating, and implementing corrective and preventive actions (CAPAs) to address deviations, non-conformances, and potential issues within the pharmaceutical manufacturing processes. 2) Scope This SOP applies…
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SOP for Change Control in Manufacturing Processes Standard Operating Procedure for Change Control in Manufacturing Processes 1) Purpose The purpose of this SOP is to establish procedures for initiating, evaluating, implementing, and documenting changes to manufacturing processes to maintain product quality, safety, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel…
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