QUALITY

Quality Systems Approach: A Cornerstone of Sentry BioPharma Services ApS

  • Every aspect of Sentry BioPharma Services ApS (Sentry ApS) reflects a commitment to protecting product integrity: safety, identity, strength, purity and quality (SISPQ). Sentry ApS’ 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 ApS 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 ApS 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 ApS' Quality Assurance
  • Data security
  • Quality-by-design philosophy
  • Disaster recovery plan
  • Quality Systems Manual
  • Experience in pharmaceutical import & export compliance issues
  • Preventative maintenance program
  • ICH’s risk-based approach
  • Redundant systems
  • Qualified vendors
  • Standard Operating Procedures (SOPs)
  • Quality Agreements (QAs)
  • Training
  • Validated Building Management System (BMS)
  • Validated Warehouse Management System (WMS)
  • Validation Master Plan (VMP)
  • Site Master File
  • Licensing by relevant health authorities
Sentry ApS complies, as applicable, with:
  • Executive order no. 1358 of 18 December 2012 on manufacture and import of medicinal products and intermediary products (Bekendtgørelse nr. 1358 af 18. december 2012 om fremstilling og indførsel af lægemidler og mellemprodukter)
  • Executive Order 1541 of 18 December 2019 on distribution of medicinal products (Bekendtgørelse nr. 1541 af 18. december 2019 om distribution af lægemidler)
  • European Commission Directive 2003/94/EC
  • European Commission Directive 2001/20/EC, EU clinical trial directive (until withdrawal)
  • European Commission Directive 2001/83/EC, of 6 November 2001 on the Community code relating to medicinal products for human use (until withdrawal)
  • European Commission 11. Directive 2011/62/EU on prevention of the entry into the legal supply chain of falsified medicinal products
  • Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. When made effective (expected FEB 2022) also including directives (EU) 2017/1572, 2017/1569 and Detailed Guideline 2017/8179
  • Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. When made effective (expected FEB 2022) also including directives (EU) 2017/1572, 2017/1569 and Detailed Guideline 2017/8179
  • EudraLex – Volume 4 – Good Manufacturing Practice (GMP) Guidelines
  • European Commission Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
  • 21 CFR Parts 11, 210, and 211

Proven Temperature Sensitive Project Management

For more information about how Sentry ApS’ proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry ApS via email or by phone at +45 69 17 71 66.