Qualipharma offers comprehensive support to those companies, logistic distributors, warehouses and transportation companies that are required to implement measures to avoid drugs counterfeiting in order to guarantee the quality of the product and the data integrity.
Directive 2011/62/EU of The European Parliament and of The Council, of June 2011, establishes the regulations to be followed in order to create a safety environment that guarantees it.
Some of the processes that Qualipharma master are:
- Definition and support in serialization projects’ implementation for products taking into account logistic distributors, warehouses and transportation companies to verify the drug’s identity.
- Definition and implementation of the adequate methodology to be used for suppliers and client’s qualifications to guarantee the integrity of the supply chain.
- Definition and implementation of the adequate methodology to be used for guaranteeing the traceability on the supply chain.
- Implementation of GMP and GDP regulation. Development and alignment of procedures such as fractionation, sampling, coding, package, issuance of analysis certificates, among others.
- Implementation, if needed, of analytical measures to guarantee the identity and integrity of products.
- Implementation of safety internal measures in computerized systems and facilities to ensure the detection of fraudulent manipulation, removal, lost and falsification in the supply chain.
- Validation of the computerized systems.