SOPs for Validations and Qualifications

The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying strip packaging machines used in pharmaceutical manufacturing. This SOP ensures that the strip packaging machines are correctly installed, operate according to specifications, and perform consistently under typical production conditions. The qualification process verifies the mechanical, electrical, and operational parameters of the strip packaging machine, ensuring that the packaging process meets the required regulatory and quality standards for pharmaceutical products.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying powder sieving machines used in pharmaceutical manufacturing. This SOP ensures that the sieving machines are correctly installed, operate according to specifications, and perform consistently under normal production conditions. The qualification process verifies the mechanical, electrical, and operational parameters of the sieving machine to ensure effective separation and classification of powders, thereby meeting the required regulatory and quality standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying tablet dedusters used in pharmaceutical manufacturing. This SOP ensures that tablet dedusters, which are used to remove excess powder from tablets after compression, are installed, operated, and perform according to specifications. The qualification process includes verifying the mechanical, electrical, and operational parameters of the deduster to ensure it performs effectively under normal production conditions and meets the required quality and regulatory standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of automatic tablet inspection machines used in pharmaceutical manufacturing. This SOP ensures that the tablet inspection machine is correctly installed, operates as specified, and performs consistently under normal production conditions. The qualification process verifies the accuracy, efficiency, and reliability of the inspection machine in detecting defective tablets, ensuring that only high-quality tablets are released for packaging.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying capsule filling machines used in pharmaceutical manufacturing. This SOP ensures that the capsule filling machines are installed, operated, and perform consistently under normal production conditions, ensuring that the process of filling capsules with powders, granules, or other formulations meets the required regulatory and quality standards. The qualification includes verification of mechanical components, operational parameters, and performance during typical production runs.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying high-shear and oscillating granulators used in pharmaceutical manufacturing. This SOP ensures that the granulators are installed, operate according to specifications, and perform consistently under normal production conditions, ensuring effective granulation of pharmaceutical powders. The qualification process includes verifying critical parameters such as granulation time, mixing speed, and product uniformity to guarantee that the granulation process yields products that meet regulatory and quality standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of Ribbon and V-Blenders used in pharmaceutical manufacturing. This SOP ensures that the blenders are installed, operate according to specifications, and perform consistently under production conditions, ensuring effective mixing of powders and other ingredients in accordance with product and regulatory requirements.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for performing Performance Qualification (PQ) of tablet coating machines in pharmaceutical manufacturing. This SOP ensures that the tablet coating machine operates consistently under typical production conditions and meets all performance criteria. The PQ process verifies that the equipment consistently delivers coated tablets that meet predefined quality attributes such as coating uniformity, thickness, and durability. The successful completion of PQ ensures that the coating process can reliably produce products that meet regulatory requirements and quality standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for performing Operational Qualification (OQ) of fluidized bed dryers used in the pharmaceutical manufacturing process. This SOP ensures that the fluidized bed dryers operate according to manufacturer specifications and meet all regulatory requirements. The OQ process verifies that the equipment functions as expected under normal operating conditions, including critical parameters such as airflow, temperature, and humidity control, ensuring efficient and consistent drying of pharmaceutical products.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for performing Installation Qualification (IQ) for tablet compression machines in pharmaceutical manufacturing. This SOP ensures that the tablet compression machine is installed according to manufacturer specifications and meets regulatory requirements. The IQ process verifies that the equipment is correctly installed, and all components are functioning as expected before moving on to the next stages of equipment qualification (Operational Qualification and Performance Qualification).
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