The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This is a comprehensive list of Standard Operating Procedures (SOPs) specifically tailored for the Quality Control Department within the pharmaceutical industry. Quality control is a critical component of the pharmaceutical manufacturing process, ensuring that every product meets rigorous standards for safety, efficacy, and compliance. These SOPs cover a wide range of quality control activities, including sampling, testing, documentation, equipment calibration, data integrity, and deviation management. Each SOP has been meticulously developed to align with international regulatory requirements and industry best practices. By following these SOPs diligently, your Quality Control Department can enhance operational efficiency, mitigate risks, and uphold the highest standards of product quality in the pharmaceutical industry.
Here is a list of SOPs related to Quality Control Department:
Standard Operating Procedure (SOP): Operation of UV Spectrophotometer Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of a UV Spectrophotometer. This SOP ensures accurate and reliable measurements of ultraviolet-visible (UV-Vis) absorbance or transmittance of samples, which is essential for various laboratory applications such as quantitative…
Standard Operating Procedure (SOP): Operation of Single Pan Weighing Balance Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of a Single Pan Weighing Balance. This SOP ensures accurate and reliable measurements of the mass of substances, which is essential for various laboratory and industrial applications….
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Standard Operating Procedure (SOP): Operation of Melting Point Apparatus Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of the Melting Point Apparatus. This SOP ensures accurate and reliable determination of the melting point of solid substances, which is important in various industries such as pharmaceuticals,…
Standard Operating Procedure (SOP): Operation of Refractometer Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of the refractometer. This SOP ensures accurate and reliable measurement of refractive index, which is important in various industries such as food and beverage, pharmaceuticals, and chemical manufacturing. Scope: This…
Standard Operating Procedure (SOP): Operation of pH Meter Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of the pH meter. This SOP ensures accurate and reliable pH measurements, which are essential for quality control, research, and analytical purposes in various industries. Scope: This SOP applies…
Standard Operating Procedure (SOP): Operation of Tablet Hardness Tester Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of the Tablet Hardness Tester. This SOP ensures accurate and reliable measurement of the hardness of tablets, which is an essential parameter for quality control in the pharmaceutical…
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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 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…
SOP for Stability Study Report Preparation: General steps that can be followed: 1. Identify the objective of the stability study and the regulatory guidelines that need to be adhered to. 2. Collect and record all relevant information for the study such as the product name, lot number, manufacturing date, expiration date, storage conditions, and analytical…