GDP Passport
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GDP Passport Requirements Quick Checklist
Select the desired option from the list below:
- GDP Passport: For logistics, distribution and freight forward companies
- GDP Passport/T: Only for transport and haulage companies
- GDP Passport for IMB Wholesaler Licence Holder
I. GDP Passport: For logistics, distribution and freight forward companies
- GDP Champion: 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. The nominated GDP Champion must undertake the 3-day “GDP Champion Training Course”.
- GDP Introduction: Key personnel involved in the supply chain 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. The selected personnel must undertake the half-day “GDP Introduction”.
- GDP Drivers: All drivers transporting pharmaceutical and medical devices products must undertake the 2-hour “GDP Driver Training”.
- Audit: An IEA Life Sciences Auditor will conduct an audit of the premises and the procedures that are in place to ensure they meet the requirements outlined in the GDP Passport Scheme. For further details please check “Audit Checklist”.
- Sign GDP Passport Terms and Conditions: The Applicant will have to sign and agree with the GDP Passport Terms and Conditions.
II. GDP Passport/T: Please note that this is for transport companies only
- GDP Champion: 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. The nominated GDP Champion must undertake the 3-day “GDP Champion Training Course”.
- GDP Drivers: All drivers transporting pharmaceutical and medical devices products must undertake the 2-hour “GDP Driver Training”.
- Audit: An IEA Life Sciences Auditor will conduct an audit of the premises and the procedures that are in place to ensure they meet the requirements outlined in the GDP Passport Scheme. For further details please check “Audit Checklist”.
- Sign GDP Passport Terms and Conditions: The Applicant will have to sign and agree with the GDP Passport Terms and Conditions.
III. Requirements for IMB Wholesaler License Holder
IMB Authorised Wholesalers who wish to apply for the IEA GDP Passport must proceed as follows:
a. Submit a GDP Passport Application
b. Submit the following information prior to the Audit Inspection (copies from the original documents will be sufficient, but the Auditor will have to check all the original documentation)
(i) Copy of IMB Wholesaler License
(ii) List of SOPs
(iii) Date of all GDP Training carried out
(iv) List of all staff members trained in GDP
(v) Role/position of each staff member
(vi) Assessment of each training course and staff member involved
(vii) Attendance list for each training course
(viii) Duration of each training course
(ix) Content of the training course:
I. Training outline
II. Content details
III. Course materials
(x) Trainer profile and experience
(xi) Training must have been carried out within two years prior to the date of the audit and be valid and up to date within the IEA GDP Passport two year recertification requirement, and include current guidelines and legislation. Any training that took place two years or more before the audit date will not be taken into account.
c. Receive auditor from IEA Life Sciences Ireland who will:
(i) Inspect IMB Wholesalers Authorisation and record reference number and validity dates
(ii) Inspect training records: An IEA Auditor will audit the company training records and SOPs and can request information verbally or in writing from any staff member involved in the supply chain to verify that the necessary training has been conducted and that the appropriate records are in place as per the requirements of the GDP Passport.
(iii) Inspect facilities
d. The IEA Life Sciences Ireland Auditor will send back a report on “a”, “b” and “c” above and a recommendation as to whether or not to issue a GDP Passport, and also which drivers should be covered by a GDP Driver Card. The applicant will have to show evidence that the recommendations outlined in the Audit report have been addressed.
e. The Audit Report will be also sent to the Life Sciences Ireland Steering Committee who will then decide if the applicant should be awarded the GDP Passport.
f. The GDP Passport will be valid from the date IEA Life Sciences Ireland communicate the decision of the Steering Committee for a period of 2 years. To renew the GDP Passport a GDP Audit will be required after 2 years from the date the GDP Passport was issued.
a. Submit a GDP Passport Application
b. Submit the following information prior to the Audit Inspection (copies from the original documents will be sufficient, but the Auditor will have to check all the original documentation)
(i) Copy of IMB Wholesaler License
(ii) List of SOPs
(iii) Date of all GDP Training carried out
(iv) List of all staff members trained in GDP
(v) Role/position of each staff member
(vi) Assessment of each training course and staff member involved
(vii) Attendance list for each training course
(viii) Duration of each training course
(ix) Content of the training course:
I. Training outline
II. Content details
III. Course materials
(x) Trainer profile and experience
(xi) Training must have been carried out within two years prior to the date of the audit and be valid and up to date within the IEA GDP Passport two year recertification requirement, and include current guidelines and legislation. Any training that took place two years or more before the audit date will not be taken into account.
c. Receive auditor from IEA Life Sciences Ireland who will:
(i) Inspect IMB Wholesalers Authorisation and record reference number and validity dates
(ii) Inspect training records: An IEA Auditor will audit the company training records and SOPs and can request information verbally or in writing from any staff member involved in the supply chain to verify that the necessary training has been conducted and that the appropriate records are in place as per the requirements of the GDP Passport.
(iii) Inspect facilities
d. The IEA Life Sciences Ireland Auditor will send back a report on “a”, “b” and “c” above and a recommendation as to whether or not to issue a GDP Passport, and also which drivers should be covered by a GDP Driver Card. The applicant will have to show evidence that the recommendations outlined in the Audit report have been addressed.
e. The Audit Report will be also sent to the Life Sciences Ireland Steering Committee who will then decide if the applicant should be awarded the GDP Passport.
f. The GDP Passport will be valid from the date IEA Life Sciences Ireland communicate the decision of the Steering Committee for a period of 2 years. To renew the GDP Passport a GDP Audit will be required after 2 years from the date the GDP Passport was issued.
Important Notes
Any Certificate issued will relate only to the site or sites assessed and the scope of such Certificate will be stated on the GDP Passport Certificate.
Each Certificate will be valid for a period of 2 years from the date of the training.
GDP Refresher training and Audit will be required to renew the GDP Passport Certificate
The price includes all training material and handouts. It also includes the issue of the GDP Driver Cards, the inclusion of the Drivers in the IEA GDP Trained Drivers Database.
It also includes the inclusion of the Applicant in the GDP Passport Certified Companies database, database management, publicity in the IEA web site, issue of press release to Irish press.
As per the Terms and Conditions of the IEA certified GDP Passport Scheme (Section 7 General Conditions) when an activity is outsourced, the Applicant must ensure that the subcontractors are trained by an IEA Certified GDP Trainer.
d
Each Certificate will be valid for a period of 2 years from the date of the training.
GDP Refresher training and Audit will be required to renew the GDP Passport Certificate
The price includes all training material and handouts. It also includes the issue of the GDP Driver Cards, the inclusion of the Drivers in the IEA GDP Trained Drivers Database.
It also includes the inclusion of the Applicant in the GDP Passport Certified Companies database, database management, publicity in the IEA web site, issue of press release to Irish press.
As per the Terms and Conditions of the IEA certified GDP Passport Scheme (Section 7 General Conditions) when an activity is outsourced, the Applicant must ensure that the subcontractors are trained by an IEA Certified GDP Trainer.
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