GDP 2: Regulatory Approach and the Need to be Compliant

26 October 2018
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26 October 2018, Comments 0

As explained in the first entry of the series, the importance of Good Distribution Practices (GDP) has increased in the last few years, coinciding with globalization and the derived delocalization of the production chain. This has made it important for regulatory agencies to focus on ensuring quality, safety, stability and traceability of products – both raw materials and finished products – across the complete supply chain.

The agents which participate in the supply and distribution chain of pharmaceutical products and their raw materials can be defined as:

• Wholesale distributors: According to Article 1(17) of Directive 2001/83/EC, wholesale distribution of medicinal products is defined as “all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned”. A specific authorisation, issued by an official body, is mandatory for any person or organization acting as a wholesale distributor. These agents must also be compliant with the principles and guidelines set for GDP.

• Manufacturers: Besides of producing their own products, some manufacturers are also responsible for their distribution activities. In these cases, they must also be GDP-compliant.

• Brokers: These are agents who negotiate contracts of purchase and sale. According to Article 85b of Directive 2001/83/EC, brokers of medicinal products are subjected to certain provisions applicable to wholesale distributors, as well as specific provisions on brokering.

• Third-party logistics providers: Companies storing the products over longer periods of time, who are required to hold specialized licenses to operate.

• Carriers: Carriers are only responsible for moving products from one place to another. These companies do not own the product, and they retain it only as long as necessary to deliver it. Therefore, they are not required to hold specific licences to operate. This fact makes it possible to find transport companies of very diverse typology, with some that have adapted to offer GDP-specialized services.

All of these agents are subject to GDP specific audits conducted by the main Regulatory Agencies, which are becoming increasingly frequent. The main types of observations during these inspections are listed below:

– Understaffed QA Departments.

– Inadequate follow-up and implementation of corrective and preventive actions from previous inspection.

– Insufficient handling of deviations and complaints.

– Inadequate reception control for counterfeit drugs and handling of temperature excursions during transportation.

– Deficient procedures for qualification of transporters/forwarders.

– Inadequate handling of returned medicinal products.

Some examples of findings related to GDP are available in the main reference websites of the Regulatory Agencies. In the European Community, for instance, EudraGMDP is a public list of GMP/GDP compliance and non-compliance certificates.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) published the 2016 Good Distribution Practices report in November of 2017. In this report, the UK regulatory agency shows the result of 148 inspections performed in 2016, concluding that Quality Systems are the main issue, with 22% of total findings.

On the other side of the Atlantic, in the United States, the U.S. Food and Drug Administration (FDA) also posts Warning Letters publicly on its website, where they can be checked and analysed.

 

Conclusion:

Regulatory Agencies are carrying out specific inspections in GDP to guarantee the security and quality across the complete supply chain, from manufacturers of active ingredients to last mile distributors to pharmacies.

Taken together, QPs must ensure and demonstrate to inspectors that the entire chain is under control and that good practices are followed in every stage. This becomes especially relevant in the case of carriers which, in many cases, have immature quality systems that are not aligned with pharmaceutical quality requirements.

As we will present in the following entries, an excellent way to guarantee this control is through supplier audits. Not only from a point of view of regulations compliance but also understood as an element of added value for the process, and as means to establishing fruitful relationships which allow us to grow together and safely face the new challenges that arise in the sector.

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