The objective of PYRAMID Laboratories, Inc. (PYRAMID’s) Quality Assurance (QA) program is to ensure that all manufacturing processes and data collected are scientifically valid, of known precision and accuracy and properly documented. Specifically, this means that all work is done in compliance with the applicable FDA, GLP and cGMP standards and that all documents generated meet the requirements of those standards.

The following is a summary of the key elements of PYRAMID’s QA program:

  • Intensive QA/QC Program that adheres to regulation requirements for GLP/cGMP compliance
  • Quality Assurance Unit (QAU) that is organizationally and functionally independent from operations
  • Documentation and Tracking Procedures that ensure traceability
  • Protocols that define the authority and responsibility for all individuals
  • Protocols for the Training and Implementation of all QA/QC related activities
  • Extensive Employee Training Program designed to assure consistency and compliance
  • Documentation System that details the requirements for all tests and processes including all record keeping, Batch Records, and validation procedures
  • Three-Tier Review and Release Program for all documentation, data and reports
  • Auditing Program that monitors Compliance with all the applicable regulations and guidelines