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Quality Assurance

International BioPharmaceutical Consulting, Inc. is available to help ensure that your quality programs are tailored to the developmental phase of your company in order to achieve compliance to QSR or GMP regulations. Below, we have listed some areas that our expertise encompasses.

  • Assist Clients in Achieving Compliance to QSR, GMP, GLP and ISO Regulations
  • Identification and Qualification of Domestic and Foreign Contract Manufacturers, Testing Laboratories, Warehouse and Shipping Facilities
  • Internal Audits, Pre-PAI Audits, BLA Audits
  • Assessment Audits for Regulatory Compliance of Manufacturers, Fill/Finish, Analytical/Animal Testing Laboratories
  • Product and Materials Specifications
  • Batch Record Review
  • Training Programs
  • Technical Writing – Standard Operating Procedures, Compliance Manuals, Test Methods, Specifications, Manufacturing Directions, Batch Records, Validation Protocols and Reports
  • Deviation and Change Control Programs
  • Calibration, Preventive Maintenance Programs