Delivery of not ordered goods - what to do?
Register now for ECA's GMP Newsletter
Imagine the following scenario: As a wholesaler, you receive a delivery of a drug with delivery note and invoice. However, you have not placed the order. What should you do?
Many would intuitively say that you refuse acceptance and return the goods immediately to the sender. But please accept the goods and put them in quarantine. It is possible that the goods are counterfeit and you have a duty to inform the authorities if there is any suspicion.
Then you should check your internal order processes and contact the potential supplier. If the suspicion of counterfeiting is confirmed, please inform the authorities and the manufacturing authorisation holder (MAH): " Wholesale distributors must immediately inform the competent authority and the marketing authorisation holder of any medicinal products they identify as falsified or suspect to be falsified" (EU-GDP Guideline Chapter 6.4). By the way, this also applies to brokers. See EU-GDP guidelines chapter 10.2.
Related GMP News
28/09/2021
02/09/2021
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others