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
Excited to work together on your next project?
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and welln...
Find out more
Global in-country regulatory support
510(k) Submission Introduction Top 3 Global CRO Our client is one of the largest CROs globally, with operations present in every economy. Their services range f...
Find out more
QMS Implementation for Class III Medical Device
QMS Implementation for Class III Medical Device Introduction Streamlining ISO 13485 Certification for a connected medical device. The company is a highly innova...
Find out more
Breakthrough Program
Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was lo...
Find out more
Regulatory Strategy IVDR / FDA
Regulatory Strategy IVDR / FDA Introduction Deciphex Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharma...
Find out more
EU-IVDR Technical File Remediation
EU-IVDR Technical File Remediation Introduction In Vitro Diagnostic Manufacturer Our client is a leader in high-quality, innovative diagnostic products for the ...
Find out more
Software as a medical device (SaMD)
Software as a medical device (SaMD) Introduction Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin. Types Regula...
Find out more
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive card...
Find out more
Quarterly Internal Audits
Quarterly Internal Audits Introduction Quarterly Internal Audits Our client is a start-up medical device manufacturer of a body cooling device, for those with h...
Find out more
Prosthesis manufacturer
Prosthesis manufacturer Introduction Global API Manufacturer As part of their international development strategy, our client wanted to get MDSAP certified with ...
Find out more