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GDP (Good Distribution Practice) rules

GDP (Good Distribution Practice) rulesWe have already written on how important it is for a manufacturer to manage all safety relevant processes, products preservation and customer satisfaction. The reality however shows that less and less consumers would like and choose to pick the product first-hand from the producer. Instead of that we save time relying on the producer who presumably will take care of the distribution of his or her products.

The best distribution practices are assembled in GDP (Good Distribution Practice) guidelines, which were elaborated for pharmaceutical products. Nowadays it has become a norm for a wide range of branches and producers. Whom and which processes do the requirements concern?

Area of distribution

It is expedient to include all processes after product release up to custody transfer to management. That means that GDP system will cover:

  • Areas of permanent storage (warehouses, distribution centers) and temporary storage (temporary storage warehouses, storage at airports, in places of transshipment etc).
  • All transport and courier, automobile and railway delivery, air transport.
  • All processes of product handling, including loading and unloading work, placement (product neighborhood, palletizing a.o.), packaging, protection from any negative factors.

There are no insignificant members in distribution. We will divide them into those from whom we will require compliance with GDP requirements, select them carefully, audit and monitor them, and those who are indifferent to our requirements (lack of interest in cooperation) or they are impossible to meet for different reasons.

We remember quite well dialogs with customers and them saying: “And how can we effect an airline company?”, “It is useless to communicate with rail carrier!”, “We insure our goods against spoilage during logistical operations, so a sub distributor is not so important!”.

Our rule consists in the idea that in any case we must take care of our products safety. If we have bad luck and cannot find a responsible partner-distributor, a logistics expert, we develop a special packing, our own logistical schemes etc., so there are a lot of options.

Distribution processes

Let us consider the areas, to which we must apply the best GDP practices or develop our own requirements. The main distribution processes are:

  1. Reception.
  2. Transport.
  3. Placement and storage.
  4. Assembly.
  5. Packaging.
  6. Shipment.

To significant support processes can refer:

  • Condition, service support and maintenance of infrastructure, including IT infrastructure
  • Creation and maintenance of storage conditions and transportation
  • Cleaning-up and sanitary treatment of infrastructure.
  • Identification and traceability
  • Selection, control and monitoring of contractors, suppliers, sub distributors.
  • Protection from contamination
  • Personnel training.
  • Disposal and waste disposal.
  • Processes of quality insurance (validation, audits, nonconformity management, risk analysis, change management, rules of work with claims and complaints, emergency response, data security).

Selection of requirements to be met in the distribution processes depends on risks existence and realizing, which processes can cause their emergence. The whole GDP system should be cost-efficient and effective.

Our experience in GDP projects shows a significant cost cutting of our customers for claims and complaints handling, scrap recycling and a positive growth of customer satisfaction quotient, which means trust in the producer.

Olga Kolchina
Head of GDP projects
Olga.Koltschina@tms-cs.ru