Latest News & Updates

Biologics Contribute to Growth in Pharma Products Cold-Chain Market

In its September issue, Pharmaceutical Commerce details the previous and expected contributions of biologic products to its forecast of cold-chain market growth predicting sales of cold-chain drugs and biologics will outpace overall industry growth through 2022. It is reported that “as of 2018, global...

Wednesday, September 12, 2018 | Read More

FDA Researchers Explore Fundamental Chemical Reaction that Could Threaten the Quality of Therapeutic Protein Products

In a recent news release the FDA described research it has conducted regarding detection of protein carbonylation, an oxidative reaction that may occur in therapeutic protein drug products during manufacture, storage, use, and transport potentially causing structural alterations and threatening stability,...

Tuesday, September 11, 2018 | Read More

Sentry representatives attend DCAT week

Sentry BioPharma Services is pleased to announce delegates from Sentry’s Business Development team will be in New York City attending the Drug, Chemical & Associated Technologies Association (DCAT) Week March 19th -22nd. The four-day conference brings together key sourcing, procurement and business...

Monday, March 19, 2018 | 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.