The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Maintenance of Distribution Centers Standard Operating Procedure for Maintenance of Distribution Centers 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of distribution centers in pharmaceutical manufacturing facilities to ensure efficient and safe distribution of products. 2) Scope This SOP applies to all distribution centers used…
SOP for Analytical Method Development Analytical Software Validation Analytical Software Validation in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for validating analytical software used in analytical method development, ensuring that the software meets predefined requirements for accuracy, reliability, and data integrity. 2) Scope This SOP applies to…
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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 Corrective and Preventive Actions (CAPA) in Aerosol Production Standard Operating Procedure for Corrective and Preventive Actions (CAPA) in Aerosol 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 issues encountered…
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SOP for Maintenance of Warehouses Standard Operating Procedure for Maintenance of Warehouses 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of warehouses in pharmaceutical manufacturing facilities to ensure proper storage and handling of materials and products. 2) Scope This SOP applies to all warehouses used within the…
SOP for Pharmacovigilance Safety Review Committee (SRC) Guidelines for the Pharmacovigilance Safety Review Committee 1) Purpose The purpose of this SOP is to establish standardized procedures for the functioning of the Safety Review Committee (SRC) to ensure comprehensive evaluation and decision-making on safety-related issues. 2) Scope This SOP applies to all members of the Safety…
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SOP for Root Cause Analysis in Aerosol Production Standard Operating Procedure for Root Cause Analysis in Aerosol Production 1) Purpose The purpose of this SOP is to define the procedures for conducting root cause analysis (RCA) to systematically identify underlying causes of deviations, out of specification results, or other issues encountered during aerosol production. RCA…
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SOP for Maintenance of Cold Storage Rooms Standard Operating Procedure for Maintenance of Cold Storage Rooms 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of cold storage rooms in pharmaceutical manufacturing facilities to ensure proper storage conditions for temperature-sensitive materials. 2) Scope This SOP applies to all…
SOP for Pharmacovigilance Signal Evaluation Guidelines for Conducting Pharmacovigilance Signal Evaluation 1) Purpose The purpose of this SOP is to establish standardized procedures for the evaluation of safety signals to determine their impact on the benefit-risk profile of medicinal products. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the signal evaluation process,…
SOP for Out of Specification (OOS) Handling in Aerosol Production Standard Operating Procedure for Out of Specification (OOS) Handling in Aerosol Production 1) Purpose The purpose of this SOP is to establish procedures for identifying, investigating, and documenting out of specification (OOS) results encountered during aerosol production. Effective OOS handling ensures product quality, compliance with…
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