Latest News & Updates

EMA Announces Brexit Business Continuity Plan

In a press release issued on August 1, 2017, The European Medicines Agency (EMA) announced that it “has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the United Kingdom's (UK's) withdrawal from the European Union (EU) and the Agency's...

Thursday, August 3, 2017 | Read More

EU Countries Contend to Be New Host Country of the European Medicines Agency

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)...

Monday, July 31, 2017 | Read More

Sentry Hosts Local Congressman Hollingsworth and BIO Health Care Representatives

JULY 6, 2017 INDIANAPOLIS, IN  Sentry BioPharma Services recently hosted a round table discussion with Congressman Trey Hollingsworth (IN 9th District) and representatives of BIO and the Indiana Health Industry Forum (IHIF).  BIO organized the event as a part of its “535 Congressional Initiative 2017”. BIO...

Wednesday, July 12, 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.