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Prospective process validation of polyherbal cough syrup formulation

Lay Desai , Jignasa Oza , Kapil Khatri


Context: Validation study is the core subject of study in quality assurance field. Validation is necessary for the efficient use of the resources. The cost of product failure, rejects, reworks, recalls, complaints are the sufficient part of total production cost. Validation study inevitably leads to process optimization, better productivity and lower manufacturing cost. Validation concept is somewhat less implemented in herbal industries. But in today’s competitive era it is essential to adopt this approach for survival. Objective: Present work is carried out to validate the manufacturing procedure of Vasu cough syrup which is a polyherbal preparation and to provide assurance that it meets with predetermined specifications. Material and methods: Vasu cough syrup was developed and manufactured at Vasu Healthcare Private Limited, Vadodara, Gujarat. In this prospective process validation, critical process parameters were identified, the protocol and report were made and results of critical parameters were checked for three consecutive batches to assure reproducibility of the results. The activity was carried out in quality assurance department of Vasu Healthcare Private Limited. Results and discussion: Results of identified critical process parameters were checked for their compliance and also for their reproducibility for three batches. The filling and sealing quality were also determined for each batch. Conclusion: The results for all batches were complying with specifications, hence the product can be considered for scale up batches. Thus, the process of technology transfer was successfully completed.

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