Also at AIChE in November:
Alistair Gillanders, a member of the ISA88 committee, gave a useful perspective on how existing open standards such as S88 can facilitate the sharing of data to support faster and more efficient process development and the adoption of design space and QbD approaches.
The full paper is available at: http://www.scale-up.com/pubs.html.
Anjali Kataria related some results of a CRADA study underaken with FDA and a cross-section of pharmaceutical companies, underlining the problems that exist in this area:
- Data traceability and visibility were issues for both large and small companies.
- Fewer than 5% of respondents use structured databases to store drug development data.
- Drug development professionals spend, on average, five hours per week looking for data.
- Some respondents spend eight hours or more on data retrieval each week.
- Roughly two-thirds of respondents could not find the data they needed between 10 to 20% of the time, triggering rework and duplication of tests and procedures.
More details at http://conformia.com/partners/industry.php