1. Technology Transfer / Consent Decree Remediation
PHARMACEUTICAL INDUSTRY
Client
A global OTC pharmaceutical company with manufacturing facilities in the United States and Puerto Rico
The company received a consent decree and, in attempting to satisfy an FDA agreed upon remediation plan, it became apparent that the Technology Transfer plan they currently used could not demonstrate sustainability.
In order to meet the FDA requirements, Tunnell Consulting introduced an approach to Technology Transfer that had not been utilized by the client in the past and which was used to re-launch a product (NDA). The Technology Transfer activities included:
Technology Transfer Control Strategy document
Technical Product Profile document
Analytical and microbial methods verification
Characterization protocol and report, including experimental batch records
Confirmation protocol and report, including experimental batch records
Hold Time Study protocol and report, including experimental batch records
Process Validation protocol and report, including commercial batch records
Manufacturing area and equipment status assessment
Processing equipment assessment to corroborate its adequacy for the manufacturing process
Personnel readiness assessment
Each step prior to execution and post execution required Governance presentation of plan and results respectively to obtain alignment to proceed
Campaign Length protocol and report, and Continued Process Verification (CPV)
Product launch build-up support
Successful consent degree step remediation
Avoidance of fines for not meeting the consent decree remediation commitment dates
Successful product launch with projected $59 million sales forecast
This new, more proactive, approach would help avoid future citations from regulatory agencies by aligning with the current regulatory guidelines from the start of the Technology Transfer process.
Problem
Approach
Results
PT-33