The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Handling of Expired Materials Handling Expired Materials – Standard Operating Procedure 1) Purpose To establish a standardized process for handling expired materials to ensure compliance with regulatory requirements and prevent the use of expired materials in production within the pharmaceutical purchase department. 2) Scope This SOP applies to all materials, including raw materials,…
SOP for Maintenance of Water Purification Systems Standard Operating Procedure for Maintenance of Water Purification Systems 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of water purification systems to ensure the production of high-quality purified water for pharmaceutical manufacturing processes. 2) Scope This SOP applies to all…
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SOP for Handling Deviations during Manufacturing Standard Operating Procedure for Handling Deviations during Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for identifying, documenting, evaluating, and resolving deviations encountered during pharmaceutical manufacturing processes to ensure product quality and compliance. 2) Scope This SOP applies to all personnel involved in the detection,…
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SOP for Risk Management in Gels Production Standard Operating Procedure for Risk Management in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for identifying, assessing, controlling, and mitigating risks associated with gels production processes, aiming to ensure product quality, patient safety, and compliance with regulatory requirements. 2) Scope This SOP…
SOP for Corrective and Preventive Actions (CAPA) in Gels Production Standard Operating Procedure for Corrective and Preventive Actions (CAPA) in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for identifying, documenting, investigating, implementing, and verifying corrective and preventive actions (CAPA) in response to deviations, non-conformances, complaints, or other quality issues…
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SOP for Continuous Improvement Programs Standard Operating Procedure for Continuous Improvement Programs 1) Purpose This SOP outlines the procedures for implementing and managing continuous improvement programs to enhance efficiency, effectiveness, and compliance within the pharmaceutical facility. 2) Scope This SOP applies to all departments and personnel involved in identifying, implementing, and monitoring continuous improvement initiatives…
SOP for Root Cause Analysis in Gels Production Standard Operating Procedure for Root Cause Analysis in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for conducting effective root cause analysis (RCA) of deviations, non-conformances, or quality issues encountered during gels production, aiming to identify underlying causes and implement corrective actions…
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SOP for Out of Specification (OOS) Handling in Gels Production Standard Operating Procedure for Out of Specification (OOS) Handling in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the identification, investigation, and handling of Out of Specification (OOS) results encountered during gels production, ensuring accurate data interpretation, product quality…
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SOP for Maintenance of Sterilization Equipment Standard Operating Procedure for Maintenance of Sterilization Equipment 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of sterilization equipment to ensure proper sterilization and operational reliability in the pharmaceutical manufacturing process. 2) Scope This SOP applies to all sterilization equipment used…
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SOP for Deviation Handling in Gels Production Standard Operating Procedure for Deviation Handling in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of deviations that occur during gels production, ensuring product quality, process integrity, and compliance with regulatory requirements. 2) Scope This SOP…