
GMP QA Consulting
Introduction
Global API Manufacturer
The client was an API manufacturer, with a need for some support to cope with a deviation backlog.
Apotech consultant:
Two QA Consultants, with backgrounds in sterile devices.
Types of Audits
- GMP
- Tools: Ishikawa, 5M
Audit Locations
- Europe

Scope of work
Under the QA director supervision, our consultant was in charge of:
- Deviation management;
- CAPA Plan implementation;
- Investigations (cross functional teams meeting, different methodologies to manage investigations, as per the client SOPs).

80% of the deviation have been tackled

Right first time approach has been implemented

Batch review SOPs have been reviewed and upgraded based on the CAPAs and main lessons learned

Batch release has been reduced by 15%

Key numbers

Team
2 Consultants, 8+ years experience

Location
Europe

Length
12 months

Type
Time and Material