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Quality Control / Manufacturing

International BioPharmaceutical Consulting, Inc. can provide expert guidance in a wide range of Quality Control areas relating to your current needs. Following are listed some of the areas in which we can provide expert consultation.

  • QC Laboratory Design, Equipment Validation and Start-up
  • Analytical and Microbiological Methods Development and Validation
  • Water System and Clean Room Validation and Environmental Monitoring Programs
  • Raw Materials Testing Programs
  • Stability Program, Development, Data Analysis and Reports for Regulatory Submissions
  • Out-of-Specification (OOS) Investigations
  • Identification and Management of Contract Analytical Testing Labs
  • Equipment Qualification (IQ, OQ, PQ)
  • Cleaning Validation
  • Evaluation of Aseptic Processes