About

The Qplasma consulting is a specialty consultant company that supports the manufacturing, pharmaceutical, biotechnology, Food & Chemi, Plasma collections centres (Recovered & Source) and Medical Devices.

The goal of our company and its consultants harmonized to ensure the products produced by our customers are reliable and safe. The discrepancies or issues can happen at any steps of the manufacturing processes but the important art is to identify the correct root cause and define the correct CAPA to enhance the optimization through the manufacturing processes and finally presenting the stability and consistency of the finished products.

Qplasma Consulting faithful to delivering quality services to all our customers by applying the latest standards in Validation Guidance, ICH Guidelines and any other specific regional Guidelines, Process Excellence and Risk Management tools.

Services

 

Validation or Qualification

Process & Projects

Validation/qualification policies, procedures, protocols, and master plans
Technology transfer programs including processes, analytical methods, and project management
Staff training for ongoing validation programs

Equipments

Validating/qualifying computerized systems and electronic records
Validating analytical methods
Qualifying analytical equipment

IT Systems Validation (ERP/ Non-ERP)

Development and/or implementation of:

  • Validation of process, equipment, instrumentation, analytical methods, utilities, facilities and computer applications
  • Risk-based validation strategies
  • User requirements, functional and design specifications
  • Protocols, reports and test cases for IQ, OQ, PQ
  • Data migration and verification
  • ER& ES; 21 CFR Part 11 System compliance assessments and training
  • Analytical methods validation in order to specific requirements

Hyper care for systems and processes affecting validation, including:

  • Change Management
  • Configuration management
  • Retrospective validation
  • Electronic signature certification and policy
  • Periodic reviews of the GxP related areas
  • Data integrity assessments for electronic records

Quality Assurance and Controls

Qplasma consultants assists clients in:

  • Evaluation/Optimization and preparation of policies and standard operating procedures
  • Assessment/Optimization and development of the quality system (QS)
  • Assist to interpret regulations in performance and operation with industry standards
  • Setting up and effecting Root Cause Investigation, Corrective and Preventive Action (CAPA)
  • Planning and Training to meet current FDA expectations for GxP Compliance
  • Handle the Quality System and Operation of the Plasma collection centres and prepare them for the European authority inspections (Regierungspräsidium in DE, etc)

Procurement & Supply

Qplasma commercial providing:

  • Finished Pharmaceuticals (Generics, Biosimilars and Brands)
  • Human Plasma for Fractionation (Fresh Frozen Plasma)
  • Veterinary Medicines

Careers

As a young, dynamic company, we are looking for personnel increasing.
If you like to work in a dynamic company, facing new challenges and opportunities every day, then Qplasma gives you the chance to launch and develop your career.
In short, we are looking for top performers and talented newcomers who fit our existing dynamic team and looking forward to challenging tasks.
We look forward to receiving your application documents electronically (mail@qplasma.de)

Contact

Give us a call: +49 1738900718

Send us an Email: mail@qplasma.de