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Qualification & Validation

IPA Consulting Services is a preferred partner to many organizations in the Pharmaceutical, biotechnology, API, veterinary, and Natural Health Products across the world and is known for its quality, professionalism, performance and solutions.

Dedication to quality, personalized support and the success of your projects are the key for our success. You receive a cost effective validation strategy while providing the highest quality service conducted with the strictest confidentiality.

Our highly experienced validation associates have both skills and commitment to provide a superior service required to meet all of your validation and calibration, qualification, and commissioning needs in order for your organization to remain competitive, dynamic and achieve a new level of confidence. They have worked with many facilities, systems and equipment including; (WFI, clean compressed air, and HVAC), Aseptic Systems (autoclaves, depyrogenation ovens and tunnels, cleanrooms, vial washers); Biotech Systems (bioreactors and fermentors, cell harvest), APIs (reactors, mills, centrifuges) and Solid and Liquid Dosage products (blenders, tablet presses, solution prep, liquid fill machines).

By providing hands-on validation support, qualification templates, preparation and execution of validation and compliance documents, we can relieve short term workloads that can exceed your available resources.

We offer a comprehensive list of services including; Cleaning Validation, Process Validation, Computer Validation, Facility Qualification, Equipment Qualification, Temperature Mapping and much more.

When it comes to qualification and validation services, our team brings a vast amount of experience to the table in order to achieve the best in innovative solutions for your new or existing facilities. Our services include the followings:

Facilities, Critical Utilities and Equipment Qualification

  • USP Purified
  • Water-for-Injection (WFI), Reverse Osmosis, Deionized Water
  • Clean Steam
  • Clean-in-Place/Steam-in-Place
  • Compressed Gases
  • HVAC
  • Air Handling Unit (AHU) qualification
  • HEPA Filter Integrity
  • Airflow Studies
  • Clean Room
  • Class 100
  • Class 10K
  • Class 100K
  • Manufacturing Requirements Planning (MRP)
  • Building Management Systems (BMS)
  • Qualification of ancillary production rooms, production area corridors, airlocks, wash rooms and technical rooms inside production areas.

Process Validation

  • Bulk Chemical and APIs
  • Solid dosage
  • Sterilization cycles
  • Sterilize-in-place systems
  • Biotechnology
  • Vaccine Manufacturers

Process Validation provides documented evidence with a high degree of certainty that a process will consistently produce product meeting its pre-determined quality attributes. Process Validation typically occurs after the Installation Qualification (IQ), Operational Qualification (OQ), and (when required) a Performance Qualification (PQ) have been satisfactorily completed. Successful process validation requires thorough process development, identification of controlled and critical parameters and in-process and final product specifications. Typically a minimum three (3) consecutive lots of product meeting the established quality specifications are necessary for process validation. These three consecutive lots are completed at the boundaries of critical parameters.

Cleaning Validation

Cleaning validation is documented proof that one can consistently and effectively cleanse a system or equipment item. The objective of cleaning validation is to ensure that a specific cleaning process will consistently clean to predetermined limits so as to prevent contaminants (product or cleaning process related) from leaving residues that will adulterate and adversely affect the safety and quality of the next product manufactured.

  • Cleaning Validation Master Plans
  • Cycle Development
  • Design-of-Experiments (DOE)
  • Determining effective grouping strategies
  • Determination of sampling methods
  • Protocol Development and Execution
  • Swab and Rinse recovery Studies
  • Analytical Test Method Development and Validation
  • Establishing residue limits and sample acceptance criteria

Computer Systems and Software Validation

Computerized Systems that perform regulated functions must be qualified or validated. Computer validation requires a cross-functional skill set that encompasses IT expertise, working QA knowledge (including GXP practices and computer validation), business acumen, and software modeling.

IPA Consulting Services validation team understands GAMP and software development lifecycle methodology. Having specialized skill sets, our team offers a complete range of services for your computer validation needs. We EXCEL at SAP, TrackWise, Delta V, and custom software validations! We offer complete outsourced Quality Assurance services for software implementation and validation projects!

  • Preparation of Software Validation documents:
    - User Requirements Specifications (URS)
    - Functional Requirements Specifications (FRS)
    - Software Requirements Specifications (SRS)
    - Policies & Procedures Development
    - Validation Master Plan
    - Installation Qualification (IQ)
    - Operational Qualification (OQ)
    - Performance Qualification (PQ)
    - Risk Assessment
    - Hazard Analysis
    - Traceability Matrix
    - Validation SOPs
  • Execution of Validation Protocols and resolution of deviations
  • Network Qualification
  • Disaster Recovery Plans
  • 21 CFR Part 11 Training

Calibration and Metrology Services

  • Core Measurement Calibrations
  • On-site Calibration Service
  • HEPA Filter Integrity and Leak Testing
  • Non-Viable Particle Measurements
  • Temperature and Humidity Mapping
  • Analytical Equipment Qualification

Other Services

  • Technology Transfer Programs (Processes; Analytical Methods; Changes)
  • Program Assessments
  • Manufacturing, Packaging and Labeling Processes
  • Validation Specification:
    - Validation Master Plans
    - Validation Plans
    - Validation Reports
    - Design reviews
  • Test Planning:
    - Installation Qualification (IQ)
    - Operational Qualification (OQ)
    - Performance Qualification (PQ)
  • Technical Specification:
    - User Requirements Specifications (URS)
    - Functional Specifications (FS)
    - Software Design Specifications (SDS)
    - Mechanical Specifications
    - Electrical Specifications
  • Other Documentation:
    - Design Qualification (DQ)
    - Standard Operating Procedures (SOPs)
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All Rights Reserved.
Tel: 416-410-7402
Toll Free: 1-866-289-1091

420 Highway #7 East, Box 82022
Richmond Hill, Ontario
Canada L4B 3K0
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