Part I issued previously looked at the importance of addressing Data Integrity across the entire product life cycle and put a spotlight on validation as an example.
This week let us take a look at another area that demands focus from data integrity standpoint. Have you considered data integrity violations from contract manufacturers and suppliers used in the development, manufacture, distribution and supply of your products and services? Have you assessed if your service provider has the same level of GMP or GDP understanding to ensure data integrity?
Along the entire supply chain, transparency and data integrity are critical to establish processes that ultimately ensure the product quality is not compromised. All members of a global supply chain may not have adequate systems in place for data management. It is advisable to complete an assessment of contract manufacturing agreements and relationships for necessary changes.
EU GMP Guide Chapter 7 requires that the Contract Giver
- takes responsibility for control of outsourced activities
- Assesses the legality, suitability and competence of the Contactor Acceptor to carry out the outsourced activities and that the activities are carried out in compliance with GMP, GDP and/or other appropriate guidance
- Monitors and reviews the performance of the Contract Acceptor and the identification and implementation of any needed improvement
It is key that data integrity practices are taken into consideration when assessing your suppliers. Have you considered data integrity standards across the entire supply chain for example: the bulk supplier, API supplier, critical intermediate supplier, primary packager, manufacturer or distributor?
Below are some examples of approaches to verify data integrity practices with your suppliers
- Consider a collaborative effort to strengthen international partners’ data management systems and practices and to train partner employees.
- Build data integrity requirements into Quality & Technical Agreements with vendors/ suppliers.
- Prioritise data integrity in Vendor Audits and Qualifications. Verify ALCOA1 and CCEA2 criteria is applied in all review areas.
- Companies could consider a companywide approach to data governance and should not overlook the training needed for employees already familiar with operating in GMP environments.