Need for WHO-GDP certification -Dr. Piyush Gupta , Associate Director, GNH India
Illegal transportation of rare drugs poses a serious public threat to those who consume it because of the lack of hygienic and standardized conditions in which they are moved from one place to another. Counterfeit pharmaceutical products are also a real threat to public health and safety. Consequently, it is essential to protect the pharmaceutical supply chain against the perforation of such products into the hands of the consumer.
In order to curb this, a proper system must not just be established but also implemented. The WHO has set up an international protocol called the WHO- Good Distribution Practices (GDP). Good Distribution Practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which means that procurement, purchasing, storage, distribution, transportation, repackaging, relabeling, documentation and record-keeping practices are met after stringent audits and protocols.
Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards. The scheme ensures that consistent quality management systems are in place throughout the entire supply chain, from the early delivery of raw materials to the manufacturing plants, the final shipment of finished drugs to the end user. An independent assessment of compliance with international GDP requirements is the most effective way to establish that a quality management system aligns with GDP guidance. Right from the manufacturer to the doctor’s office, GDP supply chain or parameters are to be maintained.
Various persons and entities are often responsible for the handling, In some cases, however, a person or entity involved in the distribution of pharmaceutical products is only involved and is responsible for certain elements of the distribution process. The guidelines are intended to apply to all steps in the entire distribution/supply chain. The storage, trade, and distribution of pharmaceutical products are activities that are carried out by various companies, institutions and individuals. The nature of the risks involved may generally, however, be the same as those in the manufacturing environment, e.g. mix-ups, contamination, and cross-contamination.
There are aspects of distribution to which the principles of Good Manufacturing Practice (GMP) should be applied. These include, but are not limited to, storage, distribution, transportation, packaging, labeling, documentation, and record keeping practices. In order to maintain the original quality, every activity in the distribution of pharmaceutical products should be carried out according to the principles of GMP, Good Storage Practice (GSP) and Good Distribution Practice (GDP). If these processes are followed and the protocols are kept in check, there is no doubt that people who are in dire need of medication anywhere in the world will not only receive the drugs on time but also at an affordable cost with the correct efficacy and a value for their money. This will ensure that no person faces a fatal consequence for the lack of medical aid or because of complex trade regimes and will put a complete stop to the illegal smuggling of pharmaceutical products across country borders