Since differentiation of GDP from GMP is considered one of the most important transitions in the pharmaceuticals industry, indicates that GDP has attained a more important place from the perspective of the auditors.
The most important criterion for the manufacturing of the drug products is the preservation of their quality and integrity in its journey from the manufacturer to the end user.
At present , the distribution network of drug products has become increasingly complex and the number of players has also increased.
GDP guidelines issued in 2013 have imposed complex and demanding responsibilities on the distributing companies, including issues such as control of counterfeit products.
By recognizing what integrated supply chain means for our customers and always prioritizing it as the most important initiative, we use the regulations from the following regulatory authorities for Good Distribution Practices (GDP) audits;
- FDA Regulations, Guidelines
- European Union Directives
- EudraLex Guidelines
- WHO Guidelines
- MHRA Guidelines
- PIC/S Guidelines And others
A successful GDP audit should be planned in a risk-oriented manner.
Before a GDP audit, we hold meetings with our customers and perform the following analyses/assessments;
- Possible risks and their manageability are assessed at the Storage-Distribution sites where GDP audit will be performed
- A risk profile is provided for storage-distribution sites
- Risk components are evaluated successively.
- Components are classified and categorized
- Parameters such as manufacturing, technology, capacity, etc. are reviewed.
- The number of audit days and inspectors needed are determined
- Assessment reports are prepared and submitted.