With increasing complexity of global pharmaceutical supply chains, the understanding and implementation of Good Distribution Practices requirements are crucial to pharmaceutical companies. A survey was issued by the European GDP Association to gain insight into the status of Good Distribution Implementation in Europe. The response to the survey was excellent with feedback coming from over 100 companies across manufacturing, wholesalers, distributors and transporters. The results of the survey can also be downloaded at this link http://www.good-distribution-practice-group.org/gdp-download.html Firstly let’s look at the issue of implementation of 2D matrix code. For European suppliers the deadline is looming. Safety Features In 2011, the European Commission published Directive 2011/62/EC, the Falsified Medicines Directive (or FMD). The FMD is designed to protect patients by minimising the chances of counterfeit medicines entering the established medicines supply chain across Europe. It will enable manufacturers, wholesalers, distributors and everyone who supplies to patients to verify the authenticity of a medicinal product, identify individual packs, and check whether the outer packaging of medicines has been tampered with. The date for the implementation of the safety features is now mandatory, it is 09 February 2019. The following safety features must be placed on the packaging of prescription medicines and certain non-prescription medicines.
- a unique identifier in a form of 2-D barcode and
- an anti-tampering device
The latest release issued by the European Commission was on 22 November 2017 when the follow-up version 8.0 of the European Commission’s questions and answer catalogue on practical implementation and technical aspects of serialisation requirements was published. https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/qa_safetyfeature_v8_0.pdf So how are the manufacturing and wholesale companies surveyed by European GDP Association faring with their implementation of the 2D matrix code?
- 25% have made good progress in implementing 2D matrix code but still have more work to do.
- 8% have fully implemented the 2D matrix code
- 40% were in early stage implementation
- 27% Requirement not relevant to them
The 40% of companies still in early stage implementation is of concern as they have less than a year to reach full implementation. Temperature Control The outcome of the survey for Temperature Control of the product also makes for interesting reading. The EU Good Distribution Practice (GDP) Guidelines (2013/C 343/01) revised in 2013 reflect the requirements and expectations of the authorities during the transport and distribution of medicinal products in a very detailed way. Howeve,r for temperature control there are further papers of clarification available in individual jurisdictions The question of temperature control is examined in detail in a questions and answers paper of the German ZLG (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten/ Central Authority of the German Federal Länder for Health Protection Regarding Medicinal Products and Medical Devices) (in German language). It states “If no constant monitoring of temperature is carried out during the transport of medicinal products a risk assessment must be made of the transportation routes. This includes especially the travel duration including special aspects of the route, the time of year and day, including the weather forecast, the vehicles used and their equipment. The results of this risk assessment have to be part of the transportation planning.” So what are the companies surveyed by European GDP Association doing in relation to monitoring product temperature in their supply chain? Distributors and transporters
- 69% monitor the temperature in every load
- 15 % monitor temperature based on risk assessment
- 15 % monitor temperature at random frequency
Wholesalers and Manufacturers
- 52% monitor the temperature in every load
- 38 % monitor temperature based on risk assessment
- 4% monitor temperature at random frequency
- 6% have no monitoring in place
This survey acts a good benchmark to view where other companies are at with their implementation of GDP. If you would like PharmaLex Ireland to assist your organisation in any of the GDP requirements , please contact us at +353 1 846 47 42 or contact irl@pharmalex.com.
