Qualification
& Engineering

The act of Validation, originally addressed only to sterilized equipment, now involves all product, process and facility matters.
Choose PQE's solutions to ensure that your plant site meets your business objectives while being fully compliant with the latest Good Manufacturing Practice regulations and standards.

Discover our solutions

Process Qualification

Make sure all equipment, facilities and systems are always fit for their intended use and avoid the risk of adulterating products.

Facility Validation

Assess the feasibility of the facility design to ensure that your plant project meets all the business objectives and the regulatory requirements.

An integrated approach

Every tool used in the manufacturing process has a high impact on product quality.
Don’t risk losing quality and trust: choose the right training, guidance and support.

  • Validate procedures, materials, equipments and systems
  • Establish a consistent product delivery
  • Prove with documented evidence the reliability of the processes
  • Avoid reject, reworks and down time
  • Ensure compliance with regulatory authorities' standards
  • Achieve growth and success

Focus on: Annex 1

With the release of the Second Issue of 2020 GMP Annex I, the standard for all sterile manufacturers has been widely extended and revised.
PQE Group has collected all the informations you need to comply in an exhaustive guide. Don’t wait: request the download now for free and get all the insights on sterile assurance.

Want to know more?

Flyer

Read our quick flyer guide about PQE Group's turnkey solutions, methodology and approach for Quality Engineering.

Webinar

Browse our Knowledge Gallery and view our free online seminar about Engineering and Strategic site master plan.

Flyer

Read our quick flyer guide about PQE Group's turnkey solutions, methodology and approach for Commissioning and Qualification.

Why PQE?

PQE Group, with multidisciplinary teams with and integrated knowledge in sterile production, oral solutions and more, can support clients with cost effective engineering solutions for Pharmaceutical, APIs, Biopharmaceutical and MD facilities to ensure that the related regulatory requirements set by FDA, EU GMP and others are met.

Full Service Portfolio

Data Integrity Full Service Portfolio

  • Qualification Protocols Writing and Execution
  • Installation, Operational and Performance Qualification
  • Validation Master Plan
  • Commissioning Plan
  • Cleaning Validation
  • Process Validation
  • Media Fill Protocols
  • Calibration services
  • Witnessing of Supplier Testing Activities (FAT/SAT support)
  • Inventory of Process Equipment and Utilities
  • Quality Risk Management
  • User Requirement Specifications
  • Technology Transfer
  • Process Analytical Technology (PAT) Support
  • Clean Room Qualification
  • Temperature Mapping Services
  • Transport Validation
  • Concept Development for Manufacturing Facilities and Laboratories
  • Support for Basic & Detail Design Support
  • Technology Transfer Support
  • Commissioning Support
  • GMP Review
  • Design Qualification
  • Construction Supervision
  • Project Management
  • Visual Factory Programs
  • Risk-Based Process Equipment & Utilities Maintenance Plans
  • Value Stream Mapping
  • Overall Equipment Efficiency (OEE)
  • De-Bottlenecking and No Added Value time reduction programs
  • Cost-Effectiveness optimization with Operational Excellence Programs
  • Lean-Production programs
  • Procurement Support
Get in touch.

We will be more than happy to help you find the most suitable solution for your business.