SOPs for Validations and Qualifications

The purpose of this Standard Operating Procedure (SOP) is to define the process for performing cleaning validation of sterile manufacturing equipment used in pharmaceutical manufacturing. This SOP ensures that cleaning procedures are validated to effectively remove residues of active pharmaceutical ingredients (APIs), excipients, cleaning agents, and microbial contaminants from sterile manufacturing equipment. The cleaning validation process verifies that the cleaning methods used are effective, reproducible, and compliant with regulatory standards to ensure product quality, safety, and sterility.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for performing cleaning validation of liquid filling equipment used in pharmaceutical manufacturing. This SOP ensures that cleaning procedures are validated to effectively remove residues of active pharmaceutical ingredients (APIs), excipients, cleaning agents, and microbial contaminants from liquid filling machines. The cleaning validation process verifies that cleaning methods are effective, reproducible, and compliant with regulatory standards to ensure product quality and safety.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for performing cleaning validation of coating pans used in pharmaceutical manufacturing. This SOP ensures that cleaning procedures are validated to effectively remove residues of active pharmaceutical ingredients (APIs), excipients, cleaning agents, and microbial contaminants from coating pans. The cleaning validation process verifies that the cleaning methods are effective, reproducible, and compliant with regulatory standards to ensure product quality and safety.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for performing cleaning validation of granulators used in pharmaceutical manufacturing. This SOP ensures that cleaning procedures are properly validated to remove residues of active pharmaceutical ingredients (APIs), excipients, cleaning agents, and microbial contaminants from granulators. The validation process verifies that the cleaning methods used are effective, reproducible, and comply with regulatory standards to ensure product quality and patient safety.
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The purpose of this Standard Operating Procedure (SOP) is to define the cleaning validation process for tablet compression machines used in pharmaceutical manufacturing. This SOP ensures that tablet compression machines are thoroughly cleaned between production batches to remove any residues of active pharmaceutical ingredients (APIs), excipients, cleaning agents, and microbial contaminants. Cleaning validation confirms that the cleaning process is effective, reproducible, and meets the required standards for safety, quality, and regulatory compliance.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying chillers and cold storage units used in pharmaceutical manufacturing and storage areas. This SOP ensures that the chillers and cold storage units are properly installed, calibrated, and operate according to the required specifications. The qualification process verifies that these systems maintain the required temperature and humidity control for storing temperature-sensitive materials and products, while ensuring compliance with regulatory and safety standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying boilers used for steam generation in pharmaceutical manufacturing. This SOP ensures that the boilers are correctly installed, calibrated, and operate in compliance with the required specifications. The qualification process verifies that the boilers produce clean, dry steam at the required pressure and temperature to meet the needs of pharmaceutical manufacturing processes, while ensuring compliance with regulatory and safety standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying Water Purification Systems, including Reverse Osmosis (RO) and Water for Injection (WFI) systems, used in pharmaceutical manufacturing. This SOP ensures that the water purification systems are correctly installed, calibrated, and operate according to the required specifications. The qualification process verifies that these systems provide the required water quality (RO and WFI) to meet the specifications for use in drug manufacturing while ensuring compliance with regulatory standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying air compressors used in pharmaceutical manufacturing units. This SOP ensures that the air compressors are correctly installed, calibrated, and operate according to the required specifications. The qualification process verifies that the air compressors provide clean, dry, and reliable compressed air to support various manufacturing operations while maintaining product quality and ensuring compliance with regulatory standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying Heating, Ventilation, and Air Conditioning (HVAC) systems used in non-sterile areas within pharmaceutical manufacturing environments. This SOP ensures that HVAC systems are correctly installed, calibrated, and operate according to the required specifications. The qualification process verifies that the HVAC system effectively controls temperature, humidity, airflow, and particulate contamination levels to meet the required conditions for non-sterile pharmaceutical manufacturing operations.
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