Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Why Good Distribution Practices Matter for Pharmaceutical Products
The pharmaceutical industry is one of the most regulated and quality-sensitive sectors in the world.
The quality and safety of medicines depend not only on how they are manufactured, but also on how they are distributed throughout the supply chain and this is where Good Distribution Practice comes into play.
From the manufacturer to the wholesaler, from the wholesaler to the retailer, and from the retailer to the patient, every step of the distribution process must ensure that the medicines are handled, stored, and transported under suitable conditions, as required by the marketing authorisation or product specification.
What is Good Distribution Practice?
Good distribution practices (GDP) are a set of standards that aim to ensure the quality and integrity of medicines during the distribution process. GDP covers the sourcing, handling, storage, and transportation of medicines for human use and their active ingredients. Compliance with GDP helps to prevent contamination, deterioration, adulteration, theft, and diversion of medicines. It also helps to ensure the traceability and recall of medicines in case of quality defects or safety issues.
GDP is part of the quality assurance system that applies to the pharmaceutical industry. It is based on the principles of good manufacturing practice (GMP), which is the minimum standard that a medicines manufacturer must meet in their production processes. GMP and GDP are both regulated by the national competent authorities and the European Medicines Agency (EMA) in the European Union (EU), and by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK). They are also guided by the directives and guidelines issued by the European Commission and the World Health Organization (WHO).
Who must comply by the GDP Standards?
GDP applies to all organisations that are involved in the distribution of medicines, such as manufacturer licence holders, wholesale dealer licence holders, blood establishment authorisation holders, and non-UK sites employed by UK marketing authorisation holders.
These organisations are required to obtain a licence or authorisation from the relevant authority and to undergo periodic inspections to check their compliance with GDP. The inspections are based on a risk assessment and may be announced or unannounced. The inspectors will evaluate the organisation’s quality system, personnel, premises, equipment, documentation, operations, complaints, recalls, and self-inspections.
How does GDP Compliance Benefit us?
The benefits of complying with GDP are manifold. For the organisations, it can help to improve their reputation, customer satisfaction, and business performance. It can also help to reduce the risks of legal liability, regulatory sanctions, and financial losses. For the patients, it can help to ensure that they receive medicines that are of consistent high quality, appropriate to their intended use, and meet the requirements of the marketing authorisation or product specification.
GDP is not a static concept, but a dynamic and evolving one. It needs to adapt to the changing needs and challenges of the pharmaceutical industry, such as the emergence of new technologies, the increase of globalisation, the diversification of supply chains, and the rise of counterfeit and falsified medicines. Therefore, it is important for the organisations to keep abreast of the latest developments and updates on GDP and to implement them in their daily operations.
GDP is a key element of the quality assurance system that ensures the quality and safety of medicines throughout the distribution process. By complying with GDP, the organisations can demonstrate their commitment to delivering high-quality medicines to the patients and to protecting public health.
Getting help with GDP Compliance
It is recommended to have an approved and registered consultancy train your staff in Good Distribution Practice.
Paradigm Shift Consulting Ltd have a comprehensive team of specialists with extensive experience within their fields who can support you in your compliance needs.If you’re getting started as a new business in any avenue of pharmaceutical medicines handling, or feel that you need to sharpen your procedures to prepare for an inspection, we can assist and advise.
Contact us using the form below to request more information. You can also view more posts with useful data and information on this blog page. Below is a selection:
GDP Webinar for RPs and Management