GDP Passport Scheme
Home / Business Sectors / Life Sciences Ireland / GDP Passport / GDP Passport Scheme / GDP Passport Requirements
GDP Passport Requirements |  |
1. The Service Provider must appoint a management representative at each distribution point as the in-house GDP Champion who is responsible for working closely with manufacturers and an approved GDP Trainer to ensure the company meets the requirements of becoming a GDP Passport Holder. The GDP Champion has the responsibility of being the key point of contact on all compliance and quality aspects on behalf of manufacturers and will work to continually improve GDP practices along the supply chain.
2. Key personnel involved in the warehousing of medicinal products should have the appropriate ability and experience to guarantee that the products or materials are properly stored and handled in compliance with the manufacturers’ specifications.
3. Personnel should be trained in relation to the duties assigned to them and the training sessions should be backed up by records.
Premises
4. Premises (Storage), Equipment (e.g. Transportation) & Processes (Quality System in place, security controls) must meet a set of criteria which follows the minimum standards set out under the EU Guidelines on GDP or FDA/ GMP requirements.
5. Medicinal products should be stored apart from other goods and under the conditions specified by the manufacturer, in order to avoid any deterioration by light, moisture or temperature.
6. The storage facilities should be clean, free from litter and dust and pests.
7. When specific temperature storage conditions are required, storage areas should be equipped with temperature recorders that will indicate that the required temperature range has been maintained.
8. Medicinal products with broken seals, damaged packaging or suspected of possible contamination should be notified to the Manufacturer, and kept in a clearly separated area awaiting the Manufacturers disposal instructions.
Transport and Vehicles
9. Medicinal and medical device products should be transported in such a manner that;
a. Their identity is not lost
b. They are not contaminated, and they do not contaminate other products or materials.
c. Adequate precautions are taken against spillage, breakage or theft.
d. They are secure and not subject to unacceptable degrees of heat, cold, light moisture or other adverse influence, or to attack of micro –organisms or pests.
e. Medicinal products requiring controlled temperature storage should also be transported by appropriate means.
Procedures and Records
10. Written procedures should describe the different distribution activities such as;
a. Receipt and checking of deliveries,
b. Storage, cleaning and maintenance of premises (including pest control)
c. Recording of storage conditions, security of stock on site and of consignments in transit
d. Withdrawal from stock, records of client orders, returned products, recalls etc.
e. These procedures should be signed and dated by the person assigned as the GDP Champion.
f. Records should be made each time and operation is undertaken, in such a way that all significant activities are traceable.
g. Records should be clear and readily available.
h. Records should ensure the traceability of the origin and destination of each product.
Training
11. To become a GDP Passport License Holder a Service Provider must be capable of demonstrating that all relevant personnel are trained to an acceptable level on Good Distribution Practice and that their premises and vehicles meet minimum operational/compliance standards. The GDP License will be valid for 2 years (24 months from date of issue.)
12. GDP Passport Training has 3 stages
a. GDP Champion - A GDP Champion is nominated (this person is involved at a supervisor level) and undertakes the 3 day Intermediate Training Programme
b. GDP Introduction- Half day training in GDP is completed by operational staff working in a warehousing facility.
c. GDP Driver - For transportation drivers a 2-hour training course needs to be completed.
13. All courses include assessment to demonstrate in keeping with regulator requirements that learning has taken place.
14. All participants have to successfully complete a set of questions on the training courses provided and all records of the course and assessment form part of the individuals training records. Certification is provided for each participant who has successfully completed these courses. Certification is valid for one year.
15. Temperature Control Logistics - Where the manufacturer requires temperature controls over the transportation or storage of their goods then the GDP Passport Holder is required to hold a joint GDP/TCL Passport.
16. Once a Service Provider meets the requirements set out above (premises, training, equipment) they will be issued with a GDP Passport License.
17. Renewal of GDP License
a. Refresher training must be undertaken on a bi-annual basis. This will enable Service Providers to get a renewal of their GDP License.
18. GDP Transport Card
All of the companies’ drivers assigned to the collection and delivery of Pharmaceutical, Medical Device and Diagnostic Products (PMD & DP) will be issued with a valid GDP Transport Card following completion of their training. This Card must be produced on arrival at the factory (warehouse) gate of the PMD & DP customer.
19. Service Provider Sub Contractor and third part Service Companies Where a Service Provider subcontracts road transport activates, they must ensure that all third party drivers hold a GDP Transport Card, otherwise they will not be allowed entry to the PMD&DP manufacturers or storage facility to deliver or collect products.
Factsheet 1: GDP Passport Requirements
Factsheet 2: Fact sheet 2: IMB Wholesalers + GDP Passport
 |
 |
