Cool Chain Compliance

  Good Distribution Global Guide.pdf

new GDP MARCH 2013.pdf

old GDP before MARCH 2013.pdf

New : Risk management
• The quality management system should include risk management principles
• Control and review of any outsourced activities should include risk management principles
• Temperature mapping of e.g. storage areas should be repeated according to the results of a risk assessment
• A risk based approach should be utilized when planning transportation routes.

New: Responsible Person
• Requirements: competence / experience / training; a degree in pharmacy is desirable
• Responsibilities
- Quality Management / Training / Recall
- Complaints / Returns / Falsified Medicines
- Approval Suppliers / Outsourcing
- Records / Self- Inspections and so on.
• “ The Responsible Person should fulfill his/her Responsibilities personally and should be continuously contactable ( was permanently available) “
• “ The RP may delegate duties but not responsibilities “

New: items for Procurement and Storage
• Qualification of Suppliers
• separated from other products likely to alter them
• physically segregated or based on validated computer system

Outlining specific temperature requirements: storage (Chapter 3)
• Storage areas should be temperature mapped
- seasonal variations
- initial mapping prior to use
- repeat based on risk assessment
• Location temperature monitors based on mapping
• Alarm systems should be in place - testing periodically
• All equipment should be maintained to a suitable standard
- preventive
- log book
• Equipment (e.g. temperature monitoring devices) should be calibrated regularly
• Records should be sustained

Outlining specific temperature requirements: transportation (Chapter 9)
• The required storage conditions for medicinal products should be maintained during transportation …
• Qualified temperature-control systems should be used to ensure correct transport conditions are maintained
- thermal packaging
- temperature controlled containers
- refrigerated vehicles
• Refrigerated vehicles
- temperature mapping
- monitoring devices
- temperature print out
- written procedures
• selection thermal packaging
- criteria
- qualification
- labeling

Implementation /changes: mapping
• “An initial mapping exercise should be carried out prior to commencement of use … and should be repeated according to the results of a risk assessment…”

Implementation / Changes: transportation
• “provision should be in place to minimize the temporary storage duration while awaiting the next stage of the transportation route “

Implementation / Changes: returns
• “..if they were returned within acceptable time limit, for example ten days “