The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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…
Read More “SOP for Pharmacovigilance Safety Review Committee (SRC)” »
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…
Read More “SOP for Root Cause Analysis in Aerosol Production” »
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…
Read More “SOP for Out of Specification (OOS) Handling in Aerosol Production” »
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 Maintenance of Stability Chambers Standard Operating Procedure for Maintenance of Stability Chambers 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of stability chambers in pharmaceutical manufacturing facilities to ensure accurate and reliable stability testing of products. 2) Scope This SOP applies to all stability chambers…
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…
Read More “Aerosols: SOP for Root Cause Analysis in Aerosol Production” »
SOP for Pharmacovigilance Literature Review Guidelines for Conducting Pharmacovigilance Literature Review 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting literature reviews to identify and evaluate safety information on medicinal products. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the literature review process, including safety specialists, medical…