Latest News & Updates

PIC/S Committee Meeting

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ)...

Thursday, April 6, 2017 | Read More

FDA approves drug to treat Parkinson’s Disease

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ)...

Wednesday, March 22, 2017 | Read More

DEA Warns Public of Extortion Scam by DEA Special Agent Impersonators

Sentry BioPharma Services is helping the Drug Enforcement Administration to warn the public about criminals posing as DEA Special Agents or other law enforcement personnel as part of an international extortion scheme. The criminals call the victims (who in most cases previously purchased drugs over...

Thursday, February 23, 2017 | Read More

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 (SISPQ). Sentry BioPharma's quality assurance team implements a validation master plan with periodic updates to assess and manage risk for pharmaceutical distribution, GMP storage, drug importation, and biopharmaceutical labeling and packaging.

Sentry utilizes standard operating procedures (SOPs), 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 regulatory agency requirements.

Sentry also develops custom solutions and mutually developed agreements to maintain regulatory compliance for clients engaging in drug importation, pharmaceutical labeling and packaging, and international drug distribution. These detailed documents preserve the integrity of pharmaceutical materials and finished drug products throughout the drug supply chain, promoting safe delivery of medicines to the patient.

Sentry BioPharma Services' Quality Assurance

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

 

 

Sentry complies with:

Code of Federal Regulations, Title 21 (21 CFR) Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

Code of Federal Regulations, Title 21 (21 CFR) Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals

Code of Federal Regulations, Title 21 (21 CFR) Part 11, Electronic Records; Electronic Signatures

Code of Federal Regulations, Title 21 (21 CFR) Part 205, Guidelines for State Licensing of Wholesale Prescription Drug Distributors

Code of Federal Regulations, Title 21 (21 CFR) Part 1308, Schedules of Controlled Substances

For more information about how Sentry's quality systems can help protect product integrity, contact Sentry via email or by phone at 1-866-757-7400.