WHO GDP Audit in Mumbai

Listing ID #6586726

CDG Provides WHO GDP certification services in Mumbai.

What is Good Distribution Practices certification?

Good distribution practices (GDP) certification requires pharmaceutical product handlers to meet stringent World Health Organization (WHO) standards for safety and security. While GDP certification is not a global requirement, EU pharmaceutical companies and their logistics partners must comply with GDP regulations.

GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

Manufacturers of medicinal products have to make sure that the products will be distributed under controlled conditions. Therefore, wholesalers, transport companies, warehouses and other partners in the supply chain will have to be selected carefully. An ongoing supervision of these organisations is necessary. It is the aim of  CDG to provide a standardized scheme to audit GDP compliance at all levels of the supply chain.

It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport. Wholesalers, transport companies, and warehouses may contact us for a GDP assessment(self assessment) audit. Depending on the size of the organization and their facility we decide audit man-day. CDG is the leading compliance audit company of India providing GDP Compliance assessment services.

Good distribution practice is a set of standards for the sourcing, handling, storage, and transportation of medicines for human use and their active ingredients. Wholesale licence and authorisation holders must comply with good distribution practice to ensure the quality, safety, and security of medicinal products throughout the pharmaceutical supply chain.

GDP requirements are very similar to the requirements stated in the GMP for manufacturers in relation to storage of medicinal products. Manufacturers must comply with the product storage requirements as stated in the GMP. Iin addition, if they are responsible for the distribution of their products, they also need to follow the GDP requirements; these include storage and transportation of their products in line with the product label, ensuring its safety and security throughout the supply chain.

In the Supply Chain, many logistic activities are outsourced to service providers, e.g. logistic vendors. Transport companies do not need to hold a wholesale distribution authorisation to transport medicinal products. However, they should follow the parts of the GDP guideline relevant to their activities. Therefore transport companies need to follow GDP but will not receive a GDP certificate.

An independent assessment of compliance against international GDP requirements could be an effective way for logistic vendors to establish that their quality management systems align with the GDP requirement. ISO is an abbreviation for the International Organization for Standardization, an independent, non-governmental international organization. There are a variety of ISO standards that transport and logistic companies can implement. Achieving an ISO certification means implementing a management system that improves the processes and procedures. Before signing a contract, a standard question may be about the type of certificates the company holds. In this way, quality standards can help to gain a competitive advantage in the transport and logistics sector.