The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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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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…
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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…
SOP for Analytical Method Development Method Optimization Method Optimization in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting method optimization during the analytical method development process, improving method performance and efficiency. 2) Scope This SOP applies to all personnel involved in method optimization for analytical method…
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SOP for Maintenance of Analytical Testing Equipment Standard Operating Procedure for Maintenance of Analytical Testing Equipment 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of analytical testing equipment in pharmaceutical manufacturing facilities to ensure accurate and reliable analytical testing processes and data integrity. 2) Scope This SOP…
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