Guide to Good Distribution Practice (GDP) | Safety culture (2023)

Why are good distribution practices important?

Good distribution practices are important because they greatly affect public health. Any error in distribution can lead to shortages, delays and even introduce counterfeit drugs into the market.

Another reason PIB is important in the pharmaceutical industry is that it facilitates product traceability, which can be an important factor when officials investigate quality problems or incidents involving pharmaceuticals.

In general, following good distribution practices protects wholesale distributors from situations that could damage not only their industry reputation, but the public interest and result in the loss of a significant number of customers.

Who needs GDP certification?

according toEuropean Medicines Agency, all wholesale distributors of pharmaceuticals in the European Economic Area (EEA) require BNP certification. Likewise, GDP certification is required in the UK for anyone who intends to sell or supply medicines to people other than end users.

In the European Union (EU), GDP certificates are issued bycompetent authorityWhen the inspection officially ends or 90 days from the last day of the inspection, as long as almost all areas are GDP compliant.

In the UK good distribution practice is governed byMedicines and health products supervisory authority(MHRA). Unlike the EU, a GDP certificate is only issued if the MHRA inspector accepts the dealer's response to the letter after the inspection.

GDP guidelines or principles of good allocation practice

The following BNP guidelines are based onWorld Health Organization (WHO) Good Practice for the Distribution of MedicinesandEuropean Commission (EC) Guidelines for Good Distribution Practice for Medicinal Products for Human Use:

Quality system/Quality management

The quality system must have the organizational structure, procedures, processes, resources and actions necessary to demonstrate that the distributor meets the quality requirements. The quality management or quality system must include a documented quality policy and approved procurement and release procedures.

Wholesalers must also assess potential risks to product quality and follow upQuality risk managementPrinciples The quality system should be regularly reviewed and revised based on the recommendations of the risk assessments carried out.

personal

Management must appoint a responsible person whose responsibility includes all activities required for compliance with BNP, such as the implementation and maintenance of a quality system.

The Responsible Person (also called Qualified Person or Designated Person) is tasked with overseeing the organization's GDP training program. BNP initial and refresher training is required for all personnel involved in distribution and should cover the following topics:

• product safety
• product identification
• Detection of counterfeit substances
• Prevent counterfeit products from entering the supply chain

Distributors must keep records of all GDP training and regularly evaluate its effectiveness in promoting good distribution practices throughout the organization.

Qualifications of suppliers and customers

Wholesalers should check whether they have a wholesale distribution authorization or wholesale distributor license before selecting potential suppliers. Due diligence should be carried out, including observation of:

• Reputation or reliability of the provider
• Likelihood that the medicine offered is counterfeit
• The amount of medicine dispensed, especially if there are usually only small supplies
• price out of reach

In addition, wholesalers may only accept orders from customers who have a wholesale distribution permit, wholesale distributor license, or are licensed to supply drugs to the public.

storage

In general, stores must be clean, dry and free of vermin. Temperature and humidity levels in storage areas must be within acceptable limits. The product must be stored as far as possible from the ground and away from direct sunlight. The following items must have separate storage areas:

• return the product
• broken or damaged product
• product recall
• suspected fake
• dangerous goods

Retailers must also have precautions in place to prevent unauthorized access to the premises and prohibit the storage of food, beverages, smoking materials and personal medications in storage areas. In addition, they must ensure that the warehouse has an adequate cleaning and pest control program.

While First Expired First Out (FEFO) is recommended, exceptions to this rule are allowed as long as they are documented and not distributed.

Warehouse managers must conduct regular inventory counts and compare actual inventory with recorded inventory.

transport

Before shipping, the wholesaler must first confirm that the delivery order is valid or have a written customer replenishment plan. Once the drug is identified, it must be placed in a shipping container with a label describing handling and storage requirements and precautions, as well as the contents of the container and its source.

Once tagged, the shipping container can be loaded onto the vehicle at the appropriate time according to the delivery schedule. It is important to remember that the quality, integrity and safety of pharmaceutical products during transport remain the responsibility of the wholesaler.

Therefore, wholesalers must have measures and protocols in place to ensure:

• The medicine has not been damaged or contaminated during transport
• Maintain the necessary storage conditions throughout transport
• Vehicles and medicines in these vehicles are protected against theft

The vehicle operator must notify the wholesaler and the intended recipient if any of the above deviations occur during transport.

document

The documentation must be sufficient to enable full traceability of pharmaceutical products through distribution channels. All parties involved must be easily identifiable. These are the documentation requirements in connection with the distribution of medicinal products:

• clearly state the title, nature and purpose
• Dated and approved by authorized person
• No change without necessary authorization

All documents and records (such as dispatches and receipts) must be kept for 7 years, unless otherwise determined by national or regional authorities.

Complain, return, return

Complaints will be divided into two categories: (1) Complaints related to product quality (2) Complaints related to product distribution. In the event of quality complaints, wholesalers must immediately notify the manufacturer or the holder of the manufacturing permit. In the case of distribution complaints, the wholesalers must conduct a thorough investigation to determine the cause of the problems mentioned in the complaint.

For returns, wholesalers must make an assessment taking into account the following factors before adding the product back to salable stock:

• The nature of the returned product
• No special storage conditions are required
• return status
• Its history and the time that has passed since its release

However, if the returned item is a stolen item, it cannot be added back to salable inventory.In the event of a recall, wholesalers must notify the following supply chain stakeholders:

• Manufacturer or marketing authorization holder
• Regulators in the country or region where the wholesaler is located
• Customers and authorities in countries where the product is distributed

Wholesalers must also document the progress of the recall and issue a final report, which includes a reconciliation between deliveries and the quantity of recalled product.

Counterfeit Drugs

If a distributor discovers or suspects that a medicinal product is falsified, he must immediately notify the competent authority and the marketing authorization holder. The sale and distribution of suspected falsified medicines must cease. These products must be stored separately from other products and labeled as counterfeit and not for sale.

When a drug is confirmed to be counterfeit, a formal decision must be made to take it off the shelves. Distributors must take steps to ensure that counterfeit products do not re-enter the supply chain or end up as salable inventory.

self test

A key requirement for good distribution practices is a self-inspection program. The scope of the self-test may vary. Wholesalers may decide that less frequent comprehensive self-checks are preferable to smaller, more specific self-checks on a regular basis. However, regardless of scope, each self-test must:

• in a fair and detailed manner, and
• To be completed by designated qualified company personnel.

The results of each self-inspection must be recorded in a report noting the observations made during the inspection. Any non-compliance, deficiency or violation must be investigated and its root cause determined. Wholesalers must also establish, document and trackCorrective and preventive actions(Kappa).