GMP QA and QC Audits

GMP Suppliers – Production of high quality clinical trial materials require the coordination of a wide range of vendors from suppliers of raw materials, components, and container/closures to bulk drug manufacturers, fill/finish sites, product labeling services, and distribution centers.  Deficiencies in the products, services, or regulatory compliance with any one vendor can result in products not meeting specifications or governmental requirements.  Ultimately, increased costs are incurred by delaying or canceling the start of clinical trials.  RESQ provides the seasoned leadership our clients need in the vendor screening process. 

Veteran auditors with 20+ years of GMP manufacturing and testing experience critically assess each supplier’s Quality Systems and the facility in which your product may be made.   Thorough technical and compliance review is conducted of the processes for receipt, quarantine, and release of raw materials, validation of facility utility and manufacturing equipment,  production batch records, validation of Quality Control test equipment and product test methods, release of product, and shipping and distribution.  Support systems are also be evaluated.   Procedures and records of training, CAPA, variances/deviations, document and facility/equipment change control are measured against regulatory requirements and the specific needs of our clients.  Audit findings and recommendations are documented in coherent and detailed reports that are tailored to client needs.   RESQ auditors provide follow-up evaluations on supplier corrective actions to ensure that regulatory requirements and the needs for the product are met.

Quality System Design and Implementation – Quality Systems direct the entire process of manufacturing and releasing a high quality product.  Whether your company is virtual, mid-size, or large, careful planning, design, and implementation of standard operating procedures is essential to ensure compliance with applicable regulations and efficient time management.  RESQ’s tenured Quality professionals evaluate the client’s procedural needs and design systems that meet appropriate phases of clinical development.   RESQ also provides gap analysis services for clients planning for regulatory inspections.  RESQ staff work with the client to fill in the gaps identified with compliant yet efficient systems.

We perform:

  • Equipment Systems for Calibration and Validation
  • Procedures for Outsourcing of Manufacturing and Testing Services
  • Manufacturing Systems
  • Quality Assurance Systems
  • Document Change Control
  • Initiation and Approval of Production Variances/Deviations
  • Corrective and Preventive Action System
  • Conducting of Internal Audits
  • Procedures for Product Recall
  • Retention of GMP Materials
  • Shipping of Clinical Product
  • Customer Complaint Procedure
  • Environmental Monitoring Program for Clean Rooms
  • Sampling and Testing of Utility Systems
  • Receiving, Quarantine and Release of GMP Materials
  • GMP Raw Material Systems
  • Quality Control System for Sample Chain of Custody
  • Generation and Approval of Certificates of Analysis
  • Drug Substance and Product Stability Programs
  • Validation Master Plan
  • Supplier Quality Agreements