Latest News & Updates

Understanding the Essential Role of a Qualified Person

Sentry Biopharma's QP can provide batch certification for importation of drug products into the EU as well as audit pharma manufacturing and storage facilities. If you are a company planning to import drug products into the European Union (EU) countries including Austria, Belgium, Bulgaria,...

Thursday, November 17, 2022 | Read More

Sentry Employee, Family, and Friends Event - September 13, 2022

Sentry employees and vendor partners as well as their families and friends shared time together at the Indianapolis Indians game on September 13, 2022.  While the Indians battled the Toledo Mud Hens, the Sentry team enjoyed ballpark hot dogs, brisket, macaroni and cheese, fresh fruit, barbeque,...

Monday, October 3, 2022 | Read More

Sentry Biopharma Services: Protecting Pharmaceutical Integrity

Sentry Biopharma Services protects the integrity of temperature sensitive biopharmaceutical products during the clinical and commercial phases of development. https://youtu.be/wWcVj8SB-Es Sentry Biopharma Services specializes in the storage and global distribution of temperature sensitive biopharmaceutical...

Friday, July 1, 2022 | 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.