Product Announcement from Parameter Generation & Control, Inc.


Validation Services-Image

Parameter Generation and Control provides regulatory compliance and validation services to FDA regulated industries. Parameter provides the necessary service based on project requirements using the applicable cGMP's to ensure compliance. We provide validation support at any level, either as augmented support for part of a project or a complete turn-key solution.

Our Advantage: A unique blend of technical expertise, regulatory compliance insight, and practical hands-on operating experience.


VALIDATION & COMPLIANCE SOLUTIONS

Parameter's Validation Services Group can provide turn-key cost effective solutions to your validation and compliance challenges. Whether it is the challenge of setting up a validation or qualification program or an emergency response to a critical compliance situation, our Validation Services Team will respond to your needs with proven resolution, expertise and confidence. With Parameter's Validation Services Group you will receive the highest quality service conducted with the strictest confidentiality.

Parameter provides equipment validation services ranging from individual bench top equipment to large scale Pharmaceutical & Biotech manufacturing plants including utilities.

Services include:

  • Policy and Procedures Deployment
  • Validation Gap Assessments
  • Customized Validation Master Plan Development
  • Project Management
  • Protocol Development and Execution
  • Documentation Management
  • Design Qualification
  • Change Control
  • URS, FRS, IQ, OQ, PQ, and Final Reports
  • Factory and Site Acceptance Testing (FAT, SAT)
  • Start-Up and Commissioning
  • Installation, Operational, and Performance Qualification
  • Equipment, Facilities, and Utilities Qualification
  • Protocol Execution
  • Process Validation
  • Laboratory System Validation
  • Stability Chamber Qualification
  • Revalidation and Re-qualification
  • Validation Life Cycle Methodology
  • Final Report Development
  • Standard Operating Procedures (SOP) Development and Implementation

LABORATORY VALIDATION SERVICES

  • Laboratory equipment validation including ovens, coolers, freezers, glass washers, and environmental controls
  • Chromatography data collection systems (CMS) and instrumentation validation
  • Mass spec validation
  • UV-Vis validation
  • HPLC validation
  • GC validation
  • Analytical method validation services

EQUIPMENT VALIDATION SERVICES

  • Bulk pharmaceutical manufacturing processing trains including reactors, blenders, centrifuges, dryers, temperature controls, dispensing controls, and automated sequences
  • Solid dosage bottle, solid dosage blister, ointment, cream, liquid and sterile packaging lines including optical inspection stations and check weighers
  • Solid dosage packaging lines including bar code verification systems, bottle unscramblers, heat sealers inspection machines, lablers, pouch dispenser, and shrink bundlers
  • Pharmaceutical blenders, horizontal and vertical mixers, granulars, milling machines, dryers, drying rooms metal detectors, emulsifiers, polishing pans, fluid bed processers, weighing systems, tablet coating systems, tablet presses, and encapsulators

FACILITIES AND UTILITIES QUALIFICATION

  • Environmental control systems including HVAC systems, Building Management Systems (BMS), Clean Rooms, and Temperature / Humidity / Differential Pressure Control Systems
  • Plant utilities systems including water-for-injection (WFI), deionized water, steam system, and compressed air systems
 
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