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Quality

Quality Systems Approach: A Cornerstone of Sentry BioPharma Services

Every aspect of Sentry BioPharma Services reflects a commitment to protecting product integrity: safety, identity, strength, purity and quality. From the onset, Sentry's quality team devised a validation master plan to assess and manage risk probability and impact for pharmaceutical distribution, storage, importation, and secondary packaging.

Sentry operates from a library of operating procedures, validated inventory and building management systems and quality agreements to mitigate risk. The company also deploys a continuous improvement program to meet and exceed changing industry and governmental requirements.

While standard operating procedures (SOPs) are developed internally, Sentry develops custom client operating protocols (COPs) and quality agreements that ensure specific regulatory compliance for customers engaged in pharmaceutical import, secondary packaging, and domestic distribution. These mutually developed agreements and procedures provide ongoing visibility into Sentry’s preservation of the integrity of pharmaceutical materials and products throughout the supply chain, promoting safe delivery of medicines to the patient.

Sentry's Quality

  • Quality-by-design philosophy
  • FDA's risk-based approach
  • Validation Master Plan (VMP)
  • Document Management System (DMS)
  • Standard Operating Procedures (SOPs)
  • Validated Warehouse Management System (WMS)
  • Validated Building Management Software (BMS)
  • Client Operating Protocols (COPs)
  • Data security and backup systems
  • Preventative maintenance program
  • Disaster recovery plan
  • Training
  • Experience in pharmaceutical import & export compliance issues
 Biopharmaceutical Validation Processes

Sentry complies with

Code of Federal Regulations, Title 21 (21 CFR) Parts 210 & 211, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Finished Pharmaceuticals

Section 7, Enforcement Policy

Part 11, Electronic Records; Electronic Signatures

Part 1308.11, Requirements for Storage of Controlled Substances

Section 205, Guidelines for State Licensing of Wholesale Prescription Drug Distributors