OPEX Pharma

Reverse QbD and process improvement in pharmaceutical operations. Six Sigma projects.

We lead quality improvement and optimisation projects on legacy products.

Our Black Belt consultant makes a previous statement of quality goals and return of investment ROI.

We apply Six Sigma DMAIC methodology to identify root causes of low quality/performance, specially adapted to regulated industrial operations.

Final goal is restoring stability and process capability to reduce non-conformance rates to acceptable levels.

Process knowledge or how to get information from data

Training

We have performed “in company” seminars and workshops on applied statistics, DoE and exploratory data analysis in more than 30 pharma european and latin american companies.
The programs are always customised and the workshops use real cases on client demand under CDA.
We use software for practical sessions (JMP, Minitab) in a “hands-on” approach that let the assistants apply new learned skills immediately in their own projects.

Seminars can be delivered at your site or in webinar format.

Lean Six Sigma projects

Previous experiences tell us that the best way to apply process knowledge tools is working on a specific process.
In this case we join your multidisciplinary team (development, production, engineering, quality etc.) according to the project’s goal (optimization, quality improvement, operational improvement or troubleshooting).

Designing a robust process and measuring the state of control, verifying that the stability and capability are correct are currently GMP requirements.

Statistical support

Data Analysis is a time consuming task to be performed by qualified personnel. If you need supporting services in this area like:

Production data analysis: raw materials variability, data historian studies for PQRs or to define “on going verification” protocols and reports, stability studies, analytical method validation, process validation, root cause analysis for troubleshooting……
Design of experiments: formulation and process development, scale-up, tech-transfer and optimisation.
Design of “process intelligence” systems oriented to PAT and CPV.

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