Context & Objectives
The client required the consultant to support and coordinate regulatory compliance activities of their facility before an FDA inspection (21 CFR part 210 & 211/ 21 CFR PART 820).
Approach & Solution
- Mock audits on: Management, Documentation Management, Qualification
- Maintenance, Validation, Deviation/CAPA, Complaints &Purchasing)
- Supplier audits: Chemical methods validation, Packaging I, Excipients & reagents, API
- GMP training & coaching: Basic cGMP,QMS, Warehouse-Clean Areas-Quality Control & FDA Inspections
Results & Added Value
- FDA inspection passed successfully
- Completion of 7 Mock Audits to FDA agreement
- Completion of 7 supplier Audits
- Provision of GMP Training & Coaching (4 modules / 140 people)
