BioMetrix
Services for the Life Sciences



Validation
Calibration
Commissioning
Temperature Mapping


Why is Validation Required?

From the FDA Guidance Document “Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval (CPG 7132c.08)”:

Validation of manufacturing processes is a requirement of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR 211.100 and 211.110), and is considered an enforceable element of current good manufacturing practice for active pharmaceutical ingredients (APIs) under the broader statutory CGMP provisions of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

A validated manufacturing process has a high level of scientific assurance that it will reliably produce acceptable product. The proof of validation is obtained through rational experimental design and the evaluation of data, preferably beginning from the process development phase and continuing through the commercial production phase.

Before commercial distribution begins, a manufacturer is expected to have accumulated enough data and knowledge about the commercial production process to support post-approval product distribution. Normally, this is achieved after satisfactory product and process development, scale-up studies, equipment and system qualification, and the successful completion of the initial conformance batches.


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Validation Services

Validation Master Plan
Autoclave Cycle Development
Validation Staffing
Validation Protocol
   Installation Qualification
   Operational Qualification
   Performance Qualification
Specification Documents
   Design Specification
   Functional Specification
   User Requirement Specification
Usability Studies
AABB Consulting


Equipment Qualification & Validation Capabilities

Autoclave Validation
Depyrogenation Oven Qualification and Validation
Lyophilizer Validation
Automated Filling Machine Validation
Filling Machine Validation
Freeze Dryer Validation
Calibration Software Validation
Centrifuge Validation
Chromatography Box Validation
Cold Room Validation
Computer Systems Validation
Environmental Chamber Validation
Environmental Room Validation
Filling Machine Validation
Freezer Validation
Glass Washer Validation
Humidity Chamber Validation
Incubator Validation
Laboratory Monitoring System Validation
Mixer Validation
Oven Validation
PLC Validation
Refrigerator Validation
Shaker Validation
Software Validation
Stability Chamber Validation
Stir Plate Validation
Stirrer Validation
Warm Room Validation


  • Biometrix Corporation
  • 301 Edgewater Place, Suite 100
  • Wakefield, MA 01880
  • www.biometrix.com
  • Tel: (978) 338-5263