The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Flowability Testing in Granules Standard Operating Procedure for Flowability Testing in Granules 1) Purpose The purpose of this SOP is to outline the procedure for assessing the flowability of granule formulations in the pharmaceutical industry to ensure proper handling and processing. 2) Scope This SOP applies to all personnel involved in flowability testing…
SOP for Air Handling Unit (AHU) Standard Operating Procedure for Air Handling Unit (AHU) 1) Purpose The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Air Handling Unit (AHU) used in the manufacturing of ocular dosage forms. 2) Scope This SOP applies to the Air Handling…
SOP for Pharmacovigilance Clinical Trials Safety Reporting Guidelines for Pharmacovigilance Clinical Trials Safety Reporting 1) Purpose The purpose of this SOP is to outline procedures for the monitoring, evaluation, and reporting of safety data during clinical trials to ensure participant safety and regulatory compliance. 2) Scope This SOP applies to personnel involved in pharmacovigilance activities…
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SOP for Personnel Hygiene in MDI Production Personnel Hygiene Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for maintaining personnel hygiene standards in metered-dose inhaler (MDI) production to prevent contamination and ensure product quality. 2) Scope This SOP applies to all personnel working in MDI production areas, including…
SOP for Suppository Labeling Unit Operation and Maintenance of Suppository Labeling Unit 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository labeling unit in the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the suppository labeling…
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SOP for Batch Packaging Records (BPR) Preparation Standard Operating Procedure for Preparing Batch Packaging Records (BPR) 1) Purpose The purpose of this SOP is to establish a procedure for the preparation of Batch Packaging Records (BPR) to ensure accurate documentation of the packaging process. 2) Scope This SOP applies to all personnel involved in the…
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SOP for Managing and Archiving Batch Records Standard Operating Procedure for Managing and Archiving Batch Records 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for the management, review, approval, and archival of batch records generated during pharmaceutical manufacturing processes to ensure compliance with regulatory requirements and product quality standards….
SOP for HVAC System in Clean Room Standard Operating Procedure for HVAC System in Clean Room 1) Purpose The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the HVAC (Heating, Ventilation, and Air Conditioning) System in the clean room environment used in the manufacturing of ocular dosage…
SOP for Blend Uniformity Testing in Granules Standard Operating Procedure for Blend Uniformity Testing in Granules 1) Purpose The purpose of this SOP is to outline the procedure for conducting blend uniformity testing on granule formulations in the pharmaceutical industry to ensure homogeneity and consistency. 2) Scope This SOP applies to all personnel involved in…
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SOP for Ring Forming Tool Operation and Maintenance of Ring Forming Tool 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring forming tool used in the manufacturing process of rings. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of…
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