ABSTRACT

Objective: The purpose of this work is to perform a study on the concurrent validation of norethisterone enanthate injection 200 mg/ml that will deliver process validation approach as a quality assurance means. The process validation program will be investigated so that the plan will be designed to the character of the procedure under study. This can be performed by checking and controlling the various critical in process parameters as well as by evaluating the finish products. Method: The samples from the three consecutive batches of norethisterone enanthate injection 200 mg/ml are collected at the different stages of the manufacturing from dispensing, mixing, filtration, filling and sealing as mentioned in the sampling plan for the individual processes. Each and every parameter are analyzed and tested as per the specifications and all the data are recorded. The obtained result must be within the specified limit range. Result: The results obtained from the evaluation of different parameters like clarity of solution, filter integrity, sterility, bacterial endotoxin, visual particulate matter of filled ampoules, sealing quality and assay were found to be within specified limit range. Conclusion:The concurrent process validation studies were executed for the three successive batches of norethisterone enanthate injection 200 mg/ml. Different parameters were checked and validated as per the specification. Any variation was not observed between the batches of concurrent process validation of the norethisterone enanthate injection 200 mg/ml. Keywords: Concurrent process validation, Norethisterone enanthate, Critical parameter
Publication date: 01/07/2022

https://ijbpas.com/pdf/2022/July/MS_IJBPAS_2022_6240.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.7.6240