Latest News & Updates

The Benefits of Outsourcing Cold Storage

How full range of storage environments and services of Sentry BioPharma Services, Inc. (Sentry) save time and money for pharma companies. Released by  Sentry BioPharma Services •Contract Pharma Staff• 03.31.21A significant recent trend in the biopharma industry has been an increasing number of...

Monday, May 17, 2021 | Read More

Delivering Custom Client Solutions

Cold chain solutions provider Sentry BioPharma Services is able to adapt to meet the diverse needs of its clients. With the proliferation of biopharma products that tend to be temperature-sensitive has come the need for more custom cold chain solutions. Fortunately, Sentry BioPharma...

Tuesday, March 2, 2021 | Read More

CEO Spotlight: Tim J. Mitchell, JD

Sentry BioPharma Services’ chief executive talks about the company’s business highlights and industry trends. Tim Wright, Editor, Contract Pharma 10.14.20Sentry BioPharma Services is a wholesaler and third party logistics provider of prescription and investigational drug products, medical devices,...

Tuesday, March 2, 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.