Best practice in Wholesale of Pharmaceuticals

Objectives: Familiarize with the requirements and norms of the Good Practice Guide to Wholesale Medicines Distribution - a mandatory requirement for the distribution and storage activities in the drug industry.

Target audience: Employees of the distribution chain of medicines at all levels, employees of the Logistics department (Acquisitions, Sales, Storage, Transport, Responsible Persons).

Duration: 2 days

Agenda:
  • Introduction
     o Presentation of participants, reader and cash flow
  • Introduction and definitions
     o an overview of the Good Practice Guide
     o GBP definitions
  • Quality management
     o Principles
     o The quality system
     o Management of outsourced activities
     o Analysis and monitoring
     o Quality risk management
     o Examples of wrong practices in quality management implementation
  • Staff
     o Responsible person
     o Other categories of personnel
     o Training and hygiene
     o Exercise Required Personal Deposit
     o Examples of bad practices in implementation for personnel
  • Spaces and Equipment
     o Spaces and Control of temperature and environmental conditions
     o Computer equipment and systems
     o Qualification and validation
     o Examples of incorrect practices in implementation for spaces and equipment
  • Documentation
     o Examples of wrong practices in implementation for Documents
  • Operations
     o Qualifying suppliers and qualifying customers
     o Reception and storage of medicines
     o Safety Stock Exercise
     o Destruction of obsolete goods
     o Supply and export to third countries
     o Examples of incorrect practices in implementation for Operations
  • Complaints, returns, drugs suspected of being counterfeit and drugs withdrawn
     o Complaints and Medications returned
     o Forged medicines
     o Withdrawal of medicines
  • Outsourced activities
     o The contract supplier and beneficiary
     o Examples of wrong practices in implementation for Outsourced Activities
  • Autoinspectii
     o Examples of incorrect practices in implementation for self-inspections
  • Transport
     o Containers, packaging and labeling
     o Products that require special conditions
     o Examples of incorrect practices in implementation for Transport
  • Specific provisions for brokers
  • Discussion. Examination. Training closure.

Trainer:
Trainer with over 12 years of experience in procurement / supply chain management.

For more information, please contact us.