Latest News & Updates

Benefits of Foreign Trade Zones

A Foreign Trade Zone (FTZ), U.S. Customs and Border Protection (CBP) writes[1], is a secure area supervised by CBP, but treated as being outside United States trade boundaries.  Companies utilizing an FTZ have the legal opportunity to pay lower duty rates or possibly avoid paying them altogether as...

Thursday, September 30, 2021 | Read More

Resilience Analysis of Vaccine Supply Chain

Released by Sentry BioPharma Services In, as it says, what now appears to be a prescient discussion described in an article written in April, 2020[1], Tim Gunn wrote about how vaccine cold chain supply practices were soon going to be put to the test to store and distribute COVID-19 vaccines....

Friday, July 23, 2021 | Read More

Mitigating the Logistical Challenges Associated with Clinical Studies of Investigational Drugs

How Sentry BioPharma Services supports clinical studies with just-in-time custom labeling/kitting/packaging and more. Released by Sentry BioPharma Services Contract Pharma Staff 06.17.21As crucial to innovation as they are, clinical studies come with a unique set of logistical challenges...

Thursday, June 24, 2021 | 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)

 

 

Quality Assurance

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.