ATMP Sweden ATMP development Resources Logistics Cookbook Regulators expect

Regulators expect

What do regulators expect from companies? 

Organization and Management  

  • Follow national requirements (and local requirements if available/applicable) 
  • Having a defined roles and responsibilities in corporate organisations 
  • Having one responsible person (QP for GDP)  
  • A compliant quality manual  

Personnel  

  • Organogram (Organisational chart) 
  • Responsible person with duties defined in the job description  
  • Overall GDP training and specific training on applicable procedures  
  • Training records archived for the required time mandated by the regulators  

 

An example of Responsible Person job description:  

  • Trained in Quality Management System 
  • Authorised activities & records maintenance 
  • Training (design of training program and continuous training of personnel) 
  • Recalls/Returns/Complaints management 
  • Qualifying suppliers & customers 
  • Technical agreements 
  • Self-inspections 
  • Product description 
  • National law requirements  

Quality system  

  • Controlled documents management  
  • Deviations to be recorded 
  • Corrective and Preventive Actions (CAPA) 
  • Returns/complaints/recalls recorded and handled according to the regulations 
  • Regular audits  
  • Having a Quality Risk Management system  
  • Management review 

Facilities  

  • Monitoring of temperature and humidity  
  • Stock segregation  
  • Returns/rejects  
  • Fire protection  
  • Security  
  • Warehouse management system  
  • Qualification/validation  

Vehicles  

  • Drivers trained  
  • Temperature control/monitoring  
  • Vehicle tracker  
  • Vehicles served  
  • Backup vehicle  
  • Security  
  • Cleaning  

Shipping container and labels dispatch and receipt  

  • Suitable for use, clean and labelled  
  • Special conditions on label  
  • Procedures for damaged shipments 
  • Know the points for dispatch and receipt in the warehouse 
  • Have good documentation including environmental conditions  
  • Traceability along route  
  • Schedules and route carefully thought through  
  • Procedures for receipt  

In transit  

  • Security of shipment  
  • Full documentation to allow swift passage  
  • Product protected  
  • Special conditions to be supplied in documentation  
  • Deviations noted and reconciled  
  • Procedures for setbacks 

Audits and Self inspections  

  • Procedures on Audits  
  • Audit schedule  
  • Performed by company to assure adherence to company procedures, technical agreement and local regulations  
  • Independent review and audit  
  • Results recorded and CAPA tracked  
  • Management involved in the whole process 

Documentation  

  • Procedures/records/agreements for handling product and product information  
  • Follow good documentation practices  
  • Process to generate and approve documents  
  • Limited and by approved entities  

Complaints  

  • Procedures to differentiate types and focus on distribution only  
  • Impact on other batches  
  • Follow up action  
  • For product complaints, notify manufacturer  
  • Counterfeits: communicate with authorities and manufacturer  

Recalls  

  • System in place with procedures  
  • Responsible person keeps track 
  • Communicate with manufacturer and authorities  
  • Make system workable and check (try a mock/drill recall)  
  • Segregate recalled materials  

Returned products  

  • Procedure on returns  
  • Responsible person  
  • Segregated from regular stock  
  • Only put back into stock when confirmed acceptable (hold in quarantine)  
  • Destruction in controlled conditions  
  • Documentation of acts of destruction made  

Supplier/Customer Verification  

  • Procedure on supplier/customer verification  
  • Licenses in place for manufacturing/handling/distribution medicinal products  
  • Documented approach  
  • Periodically checked for license 

Counterfeit  

  • Procedure on handling counterfeits  
  • Responsible person keeps track 
  • Goods despatch/receipt  
  • Segregate from authentic (clearly labelled)  
  • If confirmed, do not sell but report to authorities  
  • Destruction in controlled conditions  
  • Documentation of acts of destruction made  

Import/Export  

  • Know where the product is coming from and going to  
  • Temperature/humidity conditions  
  • Duration  
  • Security  
  • Sending and receiving party appropriately licensed for the medicinal product supplied  
  • Check local regulations  

Contracts  

  • Lawyers involved  
  • Due diligence audit  
  • Technical agreement  
  • Periodic third-party audits  
  • Track and document progress of issues  
  • Avoiding counterfeits