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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
Frame 1000005946

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).
Done

80% of the deviation have been tackled

Done

Right first time approach has been implemented

Done

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

Done

Batch release has been reduced by 15%

Have a project in mind_ Let’s work together!
Client quote

Apotech’s consultant has been quickly onboarded and managed to get some results very promptly. She knew well how to use the investigation tools, and she managed to understand our SOPs and our QMS easily. Her focus on becoming familiar with our process and product has been key in her achievement. It has been a very seamless support!

Key numbers

Management

Team

2 Consultants, 8+ years experience

Charity

Location

Europe

Combo Chart

Length

12 months

WeChat

Type

Time and Material

Excited to work together on your next project?

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Are you searching for bespoke, flexible outsourced services for your Biotech or MedTech projects? Apotech offer a comprehensive range of consulting services for biologics, medical devices and other pharmaceutical products. Our extensive team of Regulatory, Quality and Engineering Consultants provide a world-class service to clients, large and small.