A Case Study in Regulatory Approval with SciCord

Aurobindo Utilizes the SciCord Platform for Successful Generic Filing

Benefits:

Using SciCord Informatics Platform, Aurobindo lab information was digitized to facilitate compliance:

1. Instrument & equipment management
2. Solution & Standard Prep
3. Training (Curriculum and Records)
4. Chemical Inventory
5. HPLC Columns
6. Analytical Execution Systems (DDU, NGI, Moisture, Leak Rate)
7. Quality Documentation (Change Control, Test Methods, protocols, investigations, deviations)
8. Validation Materials (Requirements, Risk Assessments, IQ, OQ, PQ, Validation Plans and Reports)

Situation

In 2016, Aurobindo established a new department dedicated to developing generic inhaled formulations. The competitive nature of the generic drug market necessitated speed and cost-effectiveness, putting pressure on the new development group to quickly deliver a product to market.

An expected Influx of new scientists into the group would necessitate extensive training and represented a potential source of error and non-compliance.

Quality data generated “right the first time” would be crucial for analyzing clinical material, ensuring stability, and supporting regulatory filings.

Impact:

The ability to develop and gain regulatory approval for an inhaled product would positively impact the company’s bottom line and would likely determine the future of the new development group.

Digitized data was easily identified and produced for audits.

Controlled review and approval of notebooks guaranteed adherence to defined process.

Implementation of lab execution processes ensured all required information was recorded and minimized the training required for new staff.