SOP on Process Validation

SOP on Process Validation
Process Validation is a documented program which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
Components of Validation: Some of the components commonly considered in a process validation study include – 
1. Analytical Test Procedures are used to determine the potency of the active ingredients, levels of impurities or degradation products etc. The qualification of an analytical test procedure requires demonstration of suitable accuracy, precision, specificity, sensitivity, and ruggedness of the method.
2. Instrument Calibration: One of the variable is instrument accuracy and this is controlled through calibration. The dependability and accuracy of the equipment used to monitor, control, and evaluate the process must be assured.
3. Critical Support Systems: The critical support systems must operate at a certain level in order to maintain the required level of quality of the final product. The qualification of a critical plant support system consists of three phases – design, installation and monitoring.
4. Operator qualification: The operation is the most important component in a process and the qualification of the operator by training and experience is essential. The qualified operator is trained in all aspects of the job – technical, supervisory, productivity, GMP etc.
5. Raw Materials & Packaging Materials: Qualification of materials involves the setting of specifications for all critical parameters of these materials, and their purpose in the product.
6. Equipment: The qualification of equipment starts with the design or selection process, followed by installation and verification that the equipment functions as desired.
7. Facilities: The qualification of a facility includes four phases – design, construction verification, and ongoing maintenance and monitoring.
8. Qualification of  Manufacturing Stages: For each type of pharmaceutical dosage form there are various distinct stages in the manufacturing process that need to be qualified in order to validate the complete process – 
a. For Capsules the stages are: Dispensing, blending, polishing, and packing.
b. For Dry syrups the stages are: dispensing, blending, filling & sealing, visual inspection, and packaging.
c. For Liquid Orals the stages are: dispensing, Component preparation, Compounding, filtration, Filling & sealing, Visual inspection, Leak testing & Packaging.
d. For Tablets: Dispensing, Mixing, Granulation, blending, compression, Coating, packaging.
9. Product Design: The product design consists of the formulation, container / closure system, basic manufacturing procedure, quality control specifications and methodology.

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