Good distribution practices ensure maintaining product safety and quality during distribution across the supply chain and this practice is significant for the pharmaceutical industry.

Good Distribution Practices (GDP) refers to a quality system for warehouses and distribution centers dedicated to medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards.

It ensures that consistent quality management systems are in place throughout your entire supply chain, from the early delivery of raw materials to the manufacturing plants to the final shipment of finished drugs to the end-user.

To read more about quality management in the pharmaceutical industry, click here.

What are good distribution practices?

Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines are maintained throughout the supply chain.

Compliance with GDP ensures that:

• Medicines in the supply chain are authorized in accordance with European Union (EU) legislation.

• Medicines are always stored in the right conditions, including during transportation.

• Contamination by or of other products is avoided.

• An adequate turnover of stored medicines takes place.

• The right products reach the right addressee within a satisfactory time period.

The distributor should also put in place a tracing system to enable finding faulty products and an effective recall procedure.

GDP also applies to the sourcing, storage, and transportation of active pharmaceutical ingredients and other ingredients used in the production of the medicines.

Challenges to achieving good distribution practices

Managing the quality of medicines during distribution is a challenging operation.

The challenges of the pharmaceutical products supply chain are due to its specified shelf life and storage conditions. The various dosage forms (e.g. tablets, syrups, injectables, etc.) are to be transported and stored under different environmental conditions hence all medicines cannot be handled with a general rule. viz the requirement of handling tablets, syrups, and injectables shall widely vary.

The cold chain product range of medicines is stored at a temperature between 2 to 8 O C. For cold chain products, therefore the degree of carefulness shall be more due to the fear of product failures during quality control testing by customers. The GDP guidelines are intended to be applicable to all persons and outlets involved in any aspect of the storage and distribution of pharmaceutical products from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to a patient or his or her agent.

The COVID-19 Vaccine: Case Study of Distribution Challenges

Drug and vaccine distribution visibility and risk management have long raised significant issues for the pharmaceutical sector.

With global vaccination for Covid-19, the challenges are greater than ever.

The vast demand for vaccines worldwide, coupled with constraints in qualified transportation availability and capacity, is placing intense ongoing pressure on the industry and its supply chain professionals.

A consistently high standard of management is required to address distribution risks, including:

• Distribution delay - we need to act quickly to reach seven billion people as soon as possible

• Vaccine ineffectiveness - vaccines must be maintained at specific cold chain temperatures, from the point of manufacture to the point of the needle

• Insufficient qualified logistical capacity - from international air and ocean cargo to last mile, in-country transport provision

• Weak controls and assessment processes - due to the reduction of in-person auditing

• Uneven distribution - global access to vaccines is inequitable

• Crime - from theft, diversion, or counterfeiting of vaccines

• Increased costs and inefficiencies - due to new distribution network complexities

• Brand damage - end patient trust

To address the complexities of global vaccine distribution, BSI can help you adopt best practices.

Standards that support good pharmaceutical distribution practices

The key standards to help pharmaceutical organizations implement good distribution practices are as follows:

BS EN ISO 9001 Quality management systems help companies identify gaps in their good manufacturing practices, proactively mitigating risk before problems arise. Benefits of this standard include; helping to assess gaps in quality management systems to identify areas of higher risk, developing and implementing plans to remediate quality risks, and assisting in developing quality management systems to bolster compliance.

BS ISO 28000 Risk management in supply chains enables organizations to understand hidden risks in their supply chain and equips them to handle unforeseen disruptions. This standard helps organizations to map risk across the supply chain, from API manufacturers to distributors and sites of care, develop and implement plans to respond to, and remediate supply chain risks (including manufacturing, in-transit, and distribution-related risks) and develop business impact analysis and business continuity plans.

BS EN ISO 22301 Business continuity management standards help pharmaceutical organizations understand and prioritize the threats to their business with the international standard for business continuity. It specifies the requirements for a management system to protect against, reduce the likelihood of, and ensure your business recovers from disruptive incidents.

Ensure your pharmaceutical organization is working to good distribution practices, by adding these standards to your collection today.

Discover BSI Knowledge

Want to access and manage the standards you need to ensure good distribution practices in your supply chain - all in one place? With a BSI Knowledge subscription, you will have the flexibility and visibility to manage the essential standards you need to work confidently and optimize your supply chain. Build your own custom collection of standards, or opt for access to our GBM05 Sciences & Health Care module and keep up-to-date with any relevant changes to your standards strategy. Request to learn more.