{"id":10401,"date":"2021-09-22T11:13:32","date_gmt":"2021-09-22T09:13:32","guid":{"rendered":"https:\/\/www.s4bt.it\/validation-manufacturing-intermediates\/"},"modified":"2026-02-02T09:15:39","modified_gmt":"2026-02-02T08:15:39","slug":"validation-manufacturing-intermediates","status":"publish","type":"page","link":"https:\/\/www.s4bt.it\/en\/projects\/validation-manufacturing-intermediates\/","title":{"rendered":"Hold Time Validation for intermediates in the manufacture of coated tablets for oral use."},"content":{"rendered":"\t\t
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Hold Time Validation for intermediates in the manufacture of coated tablets for oral use.<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Client: <\/strong>a company that has always been involved in the research, development and marketing of innovative drugs.<\/span><\/p>\n

Sector:<\/strong> Pharmaceutical<\/span><\/p>\n

Objective:<\/strong> To validate a manufacturing process by reducing the risk of non-conformities and observations by the inspection authorities while also achieving performance and quality objectives<\/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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In accordance with the regulatory standards of the industry and the reference guidelines <\/span>the Client company needed to study and validate the Hold Time for a pharmaceutical product, i.e. the period of time that may elapse between one processing stage and the next, during which it is essential to ensure that the physical-chemical properties of the product are preserved and microbial growth is avoided.<\/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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Our contribution<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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S4BT fielded resources with the skills and experience best suited to the characteristics of the project.<\/p>\n

The team began by conducting a preliminary assessment of the critical stages (granulation-mixing-compression-preparation of granulating and coating solutions) and the associated hold times, based on the historical data of the product and the indications of the product data sheets for the raw materials.<\/p>\n

They then focussed on verifying the impact on the cleaning validation of the
equipment involved and on the drafting and definition of the validation documentation (protocol and production version).<\/p>\n

The team co-ordinated and supervised the validation activities during manufacture<\/b>, in accordance with the validation protocol (intensive implementation of the monitoring and sampling plan and in-process controls, required for critical process stages subject to hold time studies on product batches).<\/p>\n

The S4BT professionals then prepared specific \u201con the job\u201d training<\/b> for the staff involved, after which they collected and evaluated all the analytical and process data for the definition of the maximum hold times for the manufacturing intermediates, in order to ensure a stable and reproducible process.<\/p>\n

Finally, the S4BT team focused on defining and drafting the final process report, and the issuance and definition of the new Time Control Sheet (a document that calculates and tracks the hold times between the various phases) within the Standard Production Version (a document that contains the processing instructions for a process).<\/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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Result<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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With the contribution of the skills of the S4BT professionals, the company completed the hold time validation for a specific process:<\/p>\n