Process Validation of Sterile Product

Author(s)

Warkad, P. R., Joshi, A. M., Wagdarikar, M., Kakad, S., Nadendla, S.

Author's Affiliation

Abstract

Process validation studies examine a process under normal operating conditions to prove that the process is in control. Once the process has been validated, it is expected that it remains in control, provided no changes are made. In the event that modifications to the process are made, or problems occur, or equipment or systems involved in the process are changed, a re-validation of the process would be required. Very often validation studies require more measurements than they are required for the routine process. The validation must prove the consistency of the process and therefore must assess the efficiency and effectiveness of each step to produce its intended outcome. The aseptic process validation conducted for the Ondansetron Injection USP, 2 mg/mL, 2ml Single Dose Vial, was found to be complying with the acceptance criteria. Thus documented evidence for the manufacturing process for the Ondansetron Injection USP, 2 mg/mL, 2ml Single Dose Vial, was shown that the process has consistently produced the product within the predetermined specifications. From the review of data recorded during manufacturing process, in process testing and finished product analysis of all the three validation batches, it is concluded that the manufacturing process is consistent and meets the pre-determined specifications and quality attributes. Hence the manufacturing process of Ondansetron Injection USP, 2 mg/mL, 2ml Single Dose Vial, stands validated.

Keywords

Ondansetron Injection USP, Environmental Monitoring, CFU, BET, Bioburden Test

Cite This Article

Warkad, P. R., Joshi, A. M., Wagdarikar, M., Kakad, S., & Nadendla, S. (2014). Process Validation of Sterile Product. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(3), 369-386.