GMP Validation and Qualification

Implement Lean GMP Manufacturing In Your Medical Device and Pharmaceutical Production Facilities

GMP Challenges

GMP in medical device and pharmaceutical manufacturing production facilities presents the unique challenge of keeping the balance between new developments, changes, deviations, complaints and new roles on one side and lean production of medical products on the other. 

Our goal is to evaluate which actions are most important and determine how these can be established in order to meet compliance needs.

pharmazeutische Produktionslinie
We provide over 20 years of international experience in the GMP manufacturing of medical devices and pharmaceutical products to provide our customers with “best practice”’ solutions for this challenge.

Customized Project Management Services

Our services may include complete solutions, dependent on the requirements of our clients. A complete solution may, for example, include complete project management of the qualification and validation processes.

  • ISO 13485
  • US 21 CFR Part 210 and 211
  • US 21 CFR Part 11
  • US 21 CFR Part 820

Overcome your challenges
and achieve your goals

Based on these standards, our compliance experts offer the services below to our clients.

Gap Analysis Services

Our international experts analyze your qualification and validation strategies to evaluate your needs.

Qualification and Validation Services

Implement and keep risk-based qualification and validation approaches in place.

Cleaning Validation

Complete packages for cleaning validations in the life sciences manufacturing, using a risk-based approach.

Utility Validation

Validation of pressure air, deionized water, aqua purifier, and water for injection, anchored in several national and international laws.

Clean Rooms

A risk-based approach methodology based on ISO 14664 and EU GMP Guide-Annex 1 for the qualification of clean rooms.

Validation of Computerized Systems

Validation of a wide range of applications ranging from ERPs (i.e. SAP©, Oracle©) via MES systems and LIMS to dedicated systems in analytical laboratories or on the production floor.

Process Analysis & Optimization

Analyze, create, and optimize your processes, sampling plans for in-process controls in manufacturing processes and offer complete manufacturing standards.

Lean Manufacturing Processes

Plan and provide useful strategies to help you attain the leanest manufacturing processes.
Contact Us To Discuss A Tailored Solution For Your Compliance Needs