Following a stringent process
Heavy regulation in the medical environment demands that biopharma companies, drug and medical device manufacturers follow a stringent process. After commissioning and qualification, the next step in a production project is pharmaceutical validation, which is a documentation-laden quality assurance procedure.
The Importance of Validation
The process of validation provides independent confirmation that the systems, facilities and equipment installed comply with the requirements of the end users, and it ensures the process and results of testing are documented correctly.
To perform this step, our project staff collect and evaluate data at every stage of the process from design to production. Actions taken by PharmaMatrix, LLC to achieve validation follow the 2011 FDA Guidance for Industry on Process Validation: General Principles and Practices, subsequent revisions and other industry guidance and standards.
Validation Master Plan (VMP)
The Validation Master Plan provides you with a roadmap for achieving the on-time start-up of your operations, and the validation of your existing facilities in compliance with good manufacturing practice (GMP) requirements. The lack of a comprehensive VMP and well-documented procedures is the reason many new drugs, medical devices, medical equipment, and related products are rejected by the FDA.
At PharmaMatrix, we provide validation consultants with extensive experience to work alongside your staff to ensure the validation of instruments and equipment is fast-tracked to fit with your timeline. Whether in a laboratory or a manufacturing environment, we take into account the specific regulatory criteria, the knowledge of your team, and the constraints of your budget to achieve effective pharmaceutical validation.
Design Review and Qualification (DQ)
Validation of equipment includes design review and qualification (DQ), to ensure the equipment meets the requirements of pharmaceutical manufacturing practices. This process encompasses the specifications listed on the purchase order, reviews the raw materials used to determine whether they comply with the standards of the industry, and records any potential deviations from the design specifications. The purpose of DQ is to reassure all regulatory agencies that the design process has been performed accurately and an audit trail is available for the entire project lifespan.
Installation Qualification (IQ)
Installation Qualification (IQ) is an FDA-regulated activity that takes place as part of the final qualification process before pharmaceutical validation begins. It includes a review of all critical components used in Direct Impact systems, to ensure:
- The components meet approved specifications
- Components are installed according to the design requirements
- Supporting documentation is available and meets required standards
- Instruments are calibrated for optimal operation.
The purpose of implementing an approved IQ protocol is to verify that all machinery and accessories are delivered as per the purchase order requirement, the equipment is installed at the specified location and all utilities needed for the functioning of the equipment are available and connected.
Operational Qualification (OQ)
This FDA-regulated process applies to all components of Direct Impact systems whose performance can affect the quality of the final product. OQ measures dimensions, ensures that instrumentation is calibrated correctly, and that all systems operate within conventional tolerances and limits. During this process, PharmaMatrix’s technical consultants test the parameters of controllers, indicators, recorders, alarms and interlocks regulating product quality. Our project staff verifies and documents all aspects of the OQ procedure for future record purposes.
Performance Qualification (PQ)
The PQ process is a documented verification that the performance of a facility or equipment meets the criteria for acceptance, such as the number of units produced, the quality of the product, and the safety features associated with the production process. This function is a final qualification step that uses substitute materials to demonstrate at a high level the effective operation of equipment or facility to deliver the required output. At PharmaMatrix, we conduct Performance Qualification after a system has been subjected to completed IQ and OQ processes.
Just as thorough documentation is essential to achieve regulatory compliance, clear user specifications are required to meet the high level of quality necessary for validation to be reliable. Our validation specialists at PharmaMatrix can be trusted to accurately translate the operating company’s terminology and expectations into documented reality. This ensures that the development of the validation protocol through change control is reliable and accurate.
Our PharmaMatrix, LLC, team has the capabilities and experience to provide you with any of the following pharmaceutical validation processes:
- Getinge, Steris, Kuhlman, Fedegari
- Stability Chamber
- Cold Warehouse
- Packed Bed Chromatography
- Custom Skid Design
- Fluid Bed Dryer systems
- Granulator Mixer
- Tablet Press
- Tablet Coating
- Extrusion Processes
- Bin Washers
- Bottle Separation
- Tablet Filler
- Bottle Capper
- Cap Sealer
- In-Line Check weighing
- Labeling applications
- Vision Systems
- Laser Coders
Sterile Fill Equipment
- Groeninger Filler
- Bausch & Stroebel Vial Washer
- Bausch & Stroebel Depyrogenation Tunnel
- Bausch & Stroebel Vial Filler
- Metall & Plastic Isolator
- Walker Isolator
- IMA Edwards Lyopholizers/Autoloader
Building Management Systems
- Motor Control Center
- Transformers / Panel Boards
- Generators / ATS
Process and Facility Control
- Allen Bradley PLC qualification
- “Black Box” Validation
- “White Box” Validation
- ABB Variable Frequency Drive commissioning/start-up
- Delta-V qualification SCADA qualification
- Software Items
- Wonder Ware
- Blue Mountain Calibration Manager
- Intellution iFix qualification
- Johnson Controls Metasys for Validated Environments (MVE)
- RS Logix
- HVAC and controls including particulate monitoring
(viable and non-viable) requirements to meet current ISO standards.
- USP and WFI water systems and tested to meet current USP and EU requirements
- Clean Steam Systems
- RO Systems
- Clean Compressed Dry Air
- Hot Water Skids used to control melt tank temperature for product melting
- Clean In Place
- Steam In Place
- Waste Management Systems
- Plant Steam
- Chilled Water
- DI Water
- Clean Steam Generation
Contact us today to discuss your pharmaceutical validation requirements and discover how biopharma companies, drug and medical device manufacturing firms can benefit from expertise offered by our qualified engineers.
*All engineering services, including automation and controls, instrumentation design, and commissioning and validation, are provided by associated entity KWW Engineering, PLLC (P-1686).