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Internal and External Audits

Independent Quality Consultants (IQC) is pleased to offer a full range of consulting services including supplier qualifications and internal/external audits at very competitive rate. Our consulting services ensures that projects are initially performed correctly and that FDA requirements are fully satisfied.

  • Contract Manufacturer Qualification: To assure that the manufacturer has the ability to maintain full compliance with cGMP and fulfill your needs.
  • Contract Laboratory Qualification: Compliance to GLP (21 CFR 58) and GCP (21 CFR 50; Informed Consent, 21 CFR Part 56; Institutional Review Boards, 21 CFR Part 312; Investigators and Sponsors, VA Regulations 38 CFR Part 16; 45 CFR Part 46, and ICH GCP Guidelines; CH-E6) is required for all testing activities associated with the non-clinical or clinical testing.
  • Supplier/Vendor Qualifications: To assure the vendor’s compliance to cGMP or ISO requirements, developing vendor qualification program and train personnel to execute the qualification plans.
  • Internal Audits: To assess the completeness of the company’s quality system, train selected internal auditors to be able to identify and define the critical processes and to focus on issues that affect product quality.
  • Reliability Maturity Assessment: A continuous reliability maturity assessment is required to review the leadership support, reliability policies, procedures, and practices defined by an organization to implement its reliability program with the intent of identifying deficiency and presenting improvements. The assessment determines the level of maturity of existing reliability program in designing, developing, and manufacturing products reflected by the management participation and dedication.