The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure (SOP): Operation of Karl Fischer Apparatus Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of the Karl Fischer Apparatus. This SOP ensures accurate and reliable determination of moisture content in samples using the Karl Fischer titration technique. Scope: This SOP applies to…
Standard Operating Procedure (SOP): Operation of Disintegration Test Machine Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of the Disintegration Test Machine. This SOP ensures accurate and reliable evaluation of the disintegration time of solid dosage forms. Scope: This SOP applies to all personnel involved…
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Standard Operating Procedure (SOP): Operation of High-Performance Liquid Chromatography (HPLC) Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of the High-Performance Liquid Chromatography (HPLC) machine. This SOP ensures accurate and reliable analysis of samples using HPLC techniques. Scope: This SOP applies to all personnel involved…
Standard Operating Procedure (SOP): Operation of Friability Test Machine Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of the Friability Test Machine. This SOP ensures accurate and reliable results during the evaluation of the physical integrity of tablets or pellets. Scope: This SOP applies to…
1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the raw material inspection procedure and to provide assurance that all raw materials used in the manufacturing process meet the specifications for quality, safety, and effectiveness. 2. Scope: This procedure applies to all raw materials received by the manufacturing facility,…
SOP for Raw Material Investigation Procedure Purpose: The purpose of the Raw Material Investigation Procedure is to ensure that all incoming raw materials meet the required specifications, minimize the risk of contamination, and prevent the usage of non-conforming raw materials in manufacturing. Scope: This SOP applies to all raw materials that are acquired for the…
Purpose: The purpose of this SOP is to define the procedure for dealing with raw material non-conformance in a consistent and efficient manner. The non-conformance should be identified and handled in a way that minimizes the impact on final product quality and customer satisfaction. Scope: This SOP applies to all raw materials used in the…
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Title: Raw Material Change Request Procedure Purpose: The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for requesting and evaluating raw material changes in compliance with regulatory requirements and company quality standards. Scope: This SOP applies to all personnel involved in raw material change requests, approval, evaluation, and implementation at [Company…
Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish a standard and consistent procedure for handling raw material complaints. The objective of this procedure is to ensure that all complaints made related to raw materials are investigated thoroughly, documented accurately, and resolved adequately to prevent future occurrences. Scope: This SOP applies to…
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Purpose: The purpose of this procedure is to define the process for reviewing Raw Material Certificates of Analysis (COA) to ensure that the raw materials received meets the required specifications and comply with regulatory requirements. Scope: This procedure applies to all raw materials received by the company. Responsibilities: The Quality Control (QC) team is responsible…
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