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Light Pharma had previously provided assistance to the client’s R&D and commercial investigations.
The client requested a plan for (and help implementing) an organization-wide implementation of best practices in the areas of Quality by Design and Investigations for pharmaceutical development and manufacturing to enable Right First Time.
Consistent approaches to Quality by Design and problem-solving across the organization.
A suite of software tools that enabled these consistent approaches.
Improved rationale for key decisions in process development, validation, root cause analysis, and effectiveness checks of improvement actions taken.
A reduction of 50% of the fraction of products with quality concerns.
The client requested a software tool to enhance knowledge and risk management for use in pharmaceutical process development, validation, and manufacturing.
The client had realized time-consuming losses of knowledge and process history during tech transfers from R&D to commercial and between sites.
A single, comprehensive software tool that enabled a consistent approach to knowledge management and risk management across the organization.
Improved use of manufacturing process intelligence which reduced re-work and confusion.
Public presentations and private meetings with the relevant regulatory bodies regarding best practices within knowledge management and risk management.
In anticipation of an upcoming site inspection, the client wanted to identify high-priority risks.
The client wanted to mitigate the risks with external project management of the mitigation activities undertaken at the site.
Light Pharma identified prioritized risks based on inspection histories of similar sites and Light Pharma’s mock inspection by ex-FDA inspectors.
Project management of responses to prioritized risks using Light Pharma’s Quality Intelligence tools.
Greater readiness for the site inspection.
The client was unable to substantiate hypothesized root causes for an investigation of a series of out-of-specification (OOS) batch manufacturing results.
A substantiated root cause for the series of OOS results.
Various corrective actions and preventive actions for reducing the likelihood of similar failures in the future for this product and others.
Use of Light Pharma’s proprietary software tool and associated multivariate analysis approaches to enact their own complex investigations in the future.
The client wanted to proactively improve the capability of a method that had significant variation relative to specifications when the method was executed repeatedly.
The method had not yet experienced out-of-specification (OOS) batch manufacturing results.
Awareness of specific and substantiated variations in the execution of the method.
Proposed changes to systematically reduce the identified common cause variations.
An improved Ppk from 0.8 to 1.4.
Broader implementation for similar methods for other products and at other sites (including R&D).
Light Pharma's Services leverage years of experience, focus and insight.
If you are interested in utilizing Light Pharma's services,
click here.
Light Pharma is a consulting and technology company on a mission to help transform the way medicine is made.
Light Pharma Private Limited
DHI Innovations Center
Arekere, Bannerghatta Road
Bangalore, India , 560076
Contact : +91 9686455720