{"id":2347,"date":"2025-04-02T17:22:25","date_gmt":"2025-04-02T17:22:25","guid":{"rendered":"https:\/\/dev.elifesciences.co\/process-validation\/"},"modified":"2025-05-08T11:09:33","modified_gmt":"2025-05-08T11:09:33","slug":"process-validation","status":"publish","type":"page","link":"https:\/\/elifesciences.co\/en\/process-validation\/","title":{"rendered":"Process validation"},"content":{"rendered":"\t\t

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Process validation<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Process under control<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Definition<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\tProcess validation is the documented evidence that a process, conducted within established parameters, operates effectively and consistently, enabling the production of a medicinal product that meets the specified requirements and quality characteristics outlined in the Specification.<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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There are several types of process validation:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tProspective validation<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t (validation conducted before the initiation of routine production of products intended for sale),<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tConcurrent validation<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t(validation conducted in exceptional circumstances, justified by significant benefits for patients, where validation studies are conducted for batches intended for sale),<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tRetrospective validation<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t (this type of validation is no longer an acceptable approach for the manufacture of medicinal products. Retrospective validation can be conducted for the manufacture of active substances.)<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Approaches to process validation:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Traditional Process Validation<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Continuous Process Verification<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Hybrid Approach<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Periodic Verification of Ongoing Process During Lifecycle<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Bracketing<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tContact us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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The process validation strategy should be defined based on factors influencing the need for validation\/revalidation, such as:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tProduct transfer<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tChanges in raw materials\/changes in material suppliers<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tNew product<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tChanges in process operational parameters<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tNew equipment\/new line\/new tools<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tScale-up<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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The purpose<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The purpose of process validation is to determine whether all relevant quality attributes and process parameters, including:<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tCritical Quality Attributes<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tCritical Process Parameters<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tCritical Material Attributes<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tCritical Inter-Process Controls<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The documentation of the assessment process for parameters, attributes, and their criticality should be clear and incorporate the results of risk analysis.<\/p>\n
The validation process for new products should include all available doses for sale and all production sites where the product is manufactured for sale. This process should be carried out by personnel routinely involved in production.<\/p>\n
Validation batches should be manufactured in quantities consistent with the registration dossier and using equipment intended for routine production batches.<\/p>\n
Process validation should be based on statistical analysis of results (using process capability indices).<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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At eLife Sciences, we provide a process validation service for:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Manufacturing of medicinal products for solid, semi-solid and liquid forms<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Manufacturing of medicinal products for inhalation forms (aerosols)<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Manufacturing of medical devices (MDR and IVDR)<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Manufacture of API active substances<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Aseptic process:
media fill<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Packaging process<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tGet in touch<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Before beginning the validation process, the following issues should be addressed:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tConducted (documented) personnel training<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tValidated analytical and microbiological methods<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tRaw materials and packaging should be supplied by qualified suppliers<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tDocumentation must be approved before the start of the process<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tFacilities, equipment, utilities, and support systems must be qualified<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tComputerized systems must be validated<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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SAMPLE PROJECT:<\/b>
Process Validation for Coated Tablet Manufacturing.<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Scope<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Validation of the tablet manufacturing process included:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Weighing of raw materials for given series<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Granule preparation and granulation<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Tableting<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Coating<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Outcome of Implementation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The validation process for the manufacture of coated tablets was carried out on a dedicated process line comprising the following equipment: weighing scales, tanks for preparing granulating fluid, a mixer-granulator, fluid bed dryer, granulation mill, rotary drum mixer, tablet press, mixer for preparing coating solution\/film, and coating machine.<\/p>\n
All of the above equipment had been previously qualified by our team (eCValidation).<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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During the process validation, critical process parameters were identified for:<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tWet granulation: mixing time, mixing speed, impeller speed, and granulation time (affecting homogeneity and granulation quality).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tDry granulation: air and product temperature, drying time, mixing time and speed.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tTablet compression: process speed, compression force.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Critical quality attributes for coated tablets were also identified, along with their testing frequency, including: mass loss after drying in the granulate, tablet mass, tablet hardness, tablet diameter, tablet thickness, disintegration time, tablet mass during and after the coating process.<\/p>\n
Despite the short project timeline, significant workload, and complexity of the process, the validation was completed within the declared project timeframe (with a positive outcome).<\/p>\n
A summary report was prepared after the validation process concluded.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Contact us to learn more about quality system implementation services.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tContact us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"
Process under control Definition Process validation is the documented evidence that a process, conducted within established parameters, operates effectively and consistently, enabling the production of a medicinal product that meets the specified requirements and quality characteristics outlined in the Specification. There are several types of process validation: Prospective validation (validation conducted before the initiation of […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":46,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-2347","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages\/2347","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/comments?post=2347"}],"version-history":[{"count":1,"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages\/2347\/revisions"}],"predecessor-version":[{"id":2348,"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages\/2347\/revisions\/2348"}],"wp:attachment":[{"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/media?parent=2347"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}