FAQs for TFDA Good Distribution Practice (GDP)

 

What is GDP?

In 2020 May, TFDA has announced a draft about Good Distribution Practice (GDP). Manufacturers with high risk products, IVD, or sterilized products will be the first to be audited by TFDA.

This practice is for companies who have pharmacist manufacturing license and those implementing import, sale, inventory, and shipment to provide traceability management record.

 

Please find the frequent asked questions about TFDA GDP from our clients below.

 

Q1: What is the official guidance or regulation on this GDP?

A1: According to Medical Devices Act, article 9, license holder and distributor are defined as dealer who should hold pharmaceutical sales license. Under the Medical Devices Act and GDP regulation, companies included by the definition must collect product import/ sale traceability record. TDFA is focusing on class III, high risk, and sterile medical devices.

 

Q2: What is the frequency for collecting the distribution record?

A2: We would recommend providing the distribution record biannually in the beginning. Then, if the import frequency is high, companies can adjust the plan to be semiannually or seasonally.

 

Q3: When would be the start date for collecting the distribution record?

A3: The distribution record which should be collected from January 2020.

 

Q4: As for the importing period, is it the air waybill (AWB) or bill of landing (BL) date?

A4: With regards to the date, we can have either AWB/BL date or import clearance date. TFDA would concern traceability, quantity, and the lot/series number of devices in the distribution activities the most.

 

Q5: Is it acceptable for products to have no Lot No. or Expiration Date?

A5: Yes, it is acceptable. In this case, companies can keep product’s series number.

 

Q6: Can I provide more information other than the shipment details?

A6: Yes, sometimes companies would need to collect the required information for different record that kept in different places.

 

Q7: If the new distributor just got the import authorization approved recently, and the inventory is from the previous distributor, should the new distributor provide the distribution record? 

A7: Yes, in this case, the new distributor could collect the inventory record from previous distributor to confirm the completeness of the product record in Taiwan.

 

Q8: If we don’t have GDP experience or enough manpower to implement GDP. Could Qualtech provide any service?

A8: Yes, Qualtech can assist with the GDP implementation by utilizing our successfully audited experience with TFDA. Feel free to contact us to have more GDP implementation advices.