A GDP-compliant certificate from Pharmatech
With GDP-compliant certification from Pharmatech, you can prove that your company complies with current GDP regulations
Having a wholesale licence is mandatory for companies that purchase, structurally store, dispense or export medicines registered outside the EEA for more than 72 hours. The IGJ conducts inspections of companies with wholesale medicine licences. These companies are eligible to obtain the GDP certificate issued by the IGJ. This GDP certificate is issued after the Inspectorate has determined that work is demonstrably done in accordance with GDP.
We assist wholesalers from A-Z in obtaining GDP certification to be issued by IGJ.
To ensure the quality of medicines throughout the distribution network, it is important that companies that store pharmaceutical products for less than 72 hours, or transport only, are also compliant with GDP. This requirement is put to them and tested by their customers (mostly wholesalers).
These, unlicensed companies, can be certified by Pharmatech. With a GDP-compliant certificate from Pharmatech, an unlicensed company can demonstrate its compliance with current GDP regulations.
Our working method
In a GDP certification process for unlicensed companies, we distinguish the following phases:
1. Define scope for the certification process
The process starts with determining the scope for certification. After we receive your request via our contact form, we will schedule a telephone consultation where you can specify which components you would like to be certified for. We therefore ask you for further information regarding the structure of the organisation, the number of employees, the number of branches, the products or services provided and the standard(s) against which the management system is to be certified.
2. Handbook review
We continue the process with an assessment of your (digital) handbook for compliance with the requirements of the chosen certification standard(s).
3. Perform certification audit
During the certification audit, everything revolves around the operation of your (quality) management system. Based on interviews with management members and employees, the auditors will focus on predefined areas of concern during the audit.
At the end of the audit, there will be a final discussion, in which you will learn from the auditors whether a positive recommendation will be issued for certification. We base this advice on a score list completed during the audit.
4. Making a report
The documentation review and certification audit are elaborated in a written report. You will receive a draft report from us within 15 working days of the audit. This report contains not only our findings and scores, but also any advice for improvement.
We have different scores in our audits:
- The score 1 is insufficient. You are not eligible for certification.
- At a score of 2, you are at GDP level, but multiple deficiencies have been identified and corrective actions will need to be initiated. You will then be eligible for a 1-year certification after you have made a plan of action.
- With a score of 3, you have more than satisfactory and are eligible for a 2-year certification.
- With a score 4, you fully meet the set requirements and are eligible for a 3-year certification.
- A score 2, 3 or 4 translates to the number of stars on your certificate
If you have one or more critical observations, you are not eligible for certification, regardless of the overall score.
5. Issue certificate
After the audit report is finalised and a score of 3 or higher is achieved, we issue a GDP-compliant certificate.
Sometimes an audit reveals that the standard(s) are not or are no longer met. In that case, it is possible to carry out an additional assessment within 3 to 6 months of the audit date and still obtain (re)certification. For this, we will prepare an additional quotation.
After the certificate is obtained, its validity is ensured by conducting a recertification audit. A recertification audit should take place at least two months before the expiry date of a certificate in order to extend its validity. During recertification, the procedure will be the same as during initial certification. We monitor the date for recertification.