SOPs for Validations and Qualifications

The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying titrators used in liquid preparation within pharmaceutical manufacturing. This SOP ensures that the titrators are correctly installed, calibrated, and operate in compliance with the required specifications. The qualification process verifies that the titration method is accurate, reproducible, and capable of providing reliable results, ensuring the quality and consistency of liquid formulations. The titrator must perform according to established parameters to meet regulatory requirements and product quality standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying batch pasteurizers used in pharmaceutical manufacturing. This SOP ensures that the pasteurization equipment is correctly installed, operates according to specifications, and performs effectively under typical production conditions. The qualification process verifies mechanical, electrical, and operational parameters to ensure that the pasteurization process consistently achieves the required temperature and time conditions necessary for product sterilization and safety, 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 ampoule and vial washing machines used in the pharmaceutical manufacturing of sterile products. This SOP ensures that the washing machines are correctly installed, operated according to specifications, and perform effectively under typical production conditions. The qualification process verifies mechanical, electrical, and operational parameters to ensure that the washing process meets the required regulatory and quality standards, including cleaning efficiency, container integrity, and adherence to aseptic conditions.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying sterile liquid filling lines used in pharmaceutical manufacturing. This SOP ensures that the filling lines are correctly installed, operate according to specifications, and perform effectively under typical production conditions. The qualification process verifies mechanical, electrical, and operational parameters to ensure that the sterile liquid filling process meets the required regulatory and quality standards, including fill accuracy, container integrity, and aseptic conditions.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying emulsification equipment used in pharmaceutical manufacturing. This SOP ensures that emulsification equipment is correctly installed, operated according to specifications, and performs effectively under typical production conditions. The qualification process verifies mechanical, electrical, and operational parameters to ensure that the emulsification process consistently produces stable emulsions that meet 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 automatic tube filling machines used in pharmaceutical manufacturing. This SOP ensures that the tube filling machines are correctly installed, operated according to specifications, and perform effectively under normal production conditions. The qualification process verifies mechanical, electrical, and operational parameters to ensure that the filling process meets the required regulatory and quality standards, including fill accuracy, sealing integrity, and labeling consistency.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying mixing tanks with agitators used in the manufacturing of pharmaceutical formulations. This SOP ensures that mixing tanks and their associated agitators are correctly installed, operated according to specifications, and perform effectively under typical production conditions. The qualification process verifies mechanical, electrical, and operational parameters to ensure that the mixing process produces homogeneous, stable mixtures that meet the required 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 homogenizers used in the manufacturing of creams and ointments. This SOP ensures that homogenizers are correctly installed, operate according to specifications, and perform effectively under typical production conditions. The qualification process ensures that the homogenizer produces uniform emulsions with the required consistency, particle size distribution, and stability, meeting the necessary regulatory and quality standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying syrup manufacturing tanks used in pharmaceutical manufacturing. This SOP ensures that the syrup manufacturing tanks 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 syrup manufacturing tanks, ensuring that the syrups produced meet the required regulatory and quality standards, including uniformity, stability, and homogeneity.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying liquid filling machines used in pharmaceutical manufacturing. This SOP ensures that the liquid filling machines are correctly installed, operate according to specifications, and perform consistently under typical production conditions. The qualification process verifies mechanical, electrical, and operational parameters to ensure that the liquid filling process meets the required regulatory and quality standards.
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