Audit & Consulting on BPF & BPD activities

10/26/2022 |
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Our experts put all their skills and experience at your service to respond to public health issues.

Our areas of intervention:

Primary & secondary packaging

Supply and storage at controlled temperature

Distribution and national and international transport

Control of the cold chain

Transport risk analysis

Drafting of specifications

etc…

Training in Good Distribution Practices (GDP)

02/08/2022 |
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The program

TRAINING GOALS

 

Helping participants become aware of the impact of wording on the expectations of drug industry leaders concerning the shipping of their medicines.

Assisting participants in acquiring knowledge of the wording necessary for adopting practices complying with the expectations of customers using the GDP framework.

Introduction

  • Presentation of the speaker, and the participants’ missions
  • Essential definitions
  • Context – The participants’ missions
  • The challenges of applying quality assurance to distribution

 

Context

  • Drugs, a product different from all others
  • The concept of “pharmaceutical establishment”
  • Glossary of key terms
  • The various players in the world of pharmaceutical distribution

 

Good DISTRIBUTION practices

  • Basic principles
  • Why manage distribution “under quality assurance”?
  • Key points: subcontracting; anti-fraud/anti-tampering; transportation and risk assessment in quality management
  • Concept of supplier accreditation: explanations
  • How does the GDP framework impact transportation?

 

MANAGing Controled TEMPERATURE

  • Regulatory benchmarks (GDP, standards, ICH, IATA)
  • Different transport options (road, air, maritime) adapted to the products
  • Solutions for controlled temperatures (storage, protections, passive/active packaging, etc.)
  • Solutions for temperature traceability
  • Qualifying transport at controlled T°: what approach does the principal take?