Author: Auditor

SOP for Sterility Testing in Aseptic Transdermal Patches

SOP for Sterility Testing in Aseptic Transdermal Patches Standard Operating Procedure for Sterility Testing in Aseptic Transdermal Patches 1) Purpose To establish a standardized procedure for conducting sterility testing in aseptic transdermal patches to ensure they are free from viable contaminating microorganisms. 2) Scope This SOP applies to the quality control (QC) and quality assurance…

Transdermal Patches

SOP for Stability Testing of IM and SC Products

SOP for Stability Testing of IM and SC Products Standard Operating Procedure for Stability Testing of IM and SC Products 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting stability testing of Intramuscular (IM) and Subcutaneous (SC) products to assess their quality, safety, and efficacy over time….

Injectables

SOP for Raw Material Inspection for Lotions

SOP for Raw Material Inspection for Lotions Standard Operating Procedure for Raw Material Inspection for Lotions 1) Purpose The purpose of this SOP is to establish procedures for the inspection and acceptance of raw materials used in the production of lotions to ensure they meet quality standards and specifications. 2) Scope This SOP applies to…

Lotions

SOP for Preparation of Metered-Dose Inhalers (MDIs)

SOP for Preparation of Metered-Dose Inhalers (MDIs) Procedure for Preparing MDIs 1) Purpose The purpose of this SOP is to outline the procedure for the preparation of metered-dose inhalers (MDIs) in the pharmaceutical industry, ensuring consistent quality and compliance with regulatory standards. 2) Scope This SOP applies to all personnel involved in the preparation of…

Metered-Dose Inhaler

SOP for Foreign Particulate Matter Testing in Transdermal Patches

SOP for Foreign Particulate Matter Testing in Transdermal Patches Standard Operating Procedure for Foreign Particulate Matter Testing in Transdermal Patches 1) Purpose To establish a standardized procedure for detecting and quantifying foreign particulate matter in transdermal patches to ensure product safety and quality. 2) Scope This SOP applies to the quality control (QC) and quality…

Transdermal Patches

SOP for Preparation of Powders

SOP for Preparation of Powders Standard Operating Procedure for Powder Preparation 1) Purpose The purpose of this SOP is to provide a standardized procedure for the preparation of powders in the pharmaceutical manufacturing process to ensure consistency, quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the preparation…

Powder & Granules

SOP for Tablet Granulation Equipment

SOP for Tablet Granulation Equipment Operation and Maintenance of Tablet Granulation Equipment 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the tablet granulation equipment to ensure the production of granules with consistent size and quality. 2) Scope This SOP applies to all personnel involved in the operation,…

Vaginal Dosage Forms

SOP for Specific Gravity Testing in Transdermal Patches

SOP for Specific Gravity Testing in Transdermal Patches Standard Operating Procedure for Specific Gravity Testing in Transdermal Patches 1) Purpose To establish a standardized procedure for conducting specific gravity testing in transdermal patches to ensure consistency and quality of the final product. 2) Scope This SOP applies to the quality control (QC) and quality assurance…

Transdermal Patches

SOP for Training Personnel in Lotions Production

SOP for Training Personnel in Lotions Production Standard Operating Procedure for Training Personnel in Lotions Production 1) Purpose The purpose of this SOP is to outline the procedures for training personnel involved in lotions production to ensure competency, adherence to standard operating procedures (SOPs), and compliance with regulatory requirements. 2) Scope This SOP applies to…

Lotions

SOP for Pharmacovigilance Vendor Management

SOP for Pharmacovigilance Vendor Management Guidelines for Managing Pharmacovigilance Vendors 1) Purpose The purpose of this SOP is to outline the procedures for selecting, qualifying, and managing vendors who provide services related to pharmacovigilance activities to ensure compliance with regulatory requirements and company standards. 2) Scope This SOP applies to all pharmacovigilance personnel involved in…

Pharmacovigilance