Certification of your pharmaceutical logistics according to Good Distribution Practices (GDP)
What is GDP certification?
The abbreviation GDP stands for Good Distribution Practices and refers in this context to the storage and transport of finished medicinal products and active ingredients.
Manufacturers of pharmaceutical products are subject to the requirements of Good Manufacturing Practices (GMP). Manufacturer quality must be ensured throughout the entire supply chain. Even slight fluctuations in temperature and humidity can affect the life and mode of action of medicines. As valuable commodities, pharmaceuticals must also be protected from theft and the introduction of counterfeit drugs into the supply chain.
GDP certification covers areas of the product lifecycle of healthcare products, particularly human pharmaceuticals and active ingredients, that arise around storage and transportation activities. A GDP compliance audit examines the sum of requirements or measures in the distribution chain that ensure the quality and integrity of pharmaceuticals.
Advantages of GDP certification
A GDP certificate identifies your company as a competent and reliable partner for pharmaceutical logistics.
The issuance of GDP certificates is regulated differently in the federal states and is partly only issued to manufacturers and distributors. Federal presidia do not consistently issue certificates to logistics companies. However, pharmaceutical manufacturers and distributors are obliged to monitor their logistics service providers. Individual customer audits involve a great deal of effort for both sides.
With the GDP audit, GUTcert helps logistics service providers to improve their performance and to communicate good distribution practices to their customers. In doing so, we commit ourselves to apply the recognized rules from our accredited ISO processes to the compliance audits against the GDP guidelines.
The document published by the European Commission under the title "Guidelines of March 7, 2013 for Good Distribution Practice of Medicinal Products for Human Use", also known as the EU-GDP Guideline, is considered the legal basis for the manufacture, storage and transport of active ingredients and ingredients. This means that the manufacturing requirements for pharmaceutical products set out in the EU-GMP guidelines are also extended to their distribution, storage and transport.
The GDP guideline is intended to ensure the quality of pharmaceuticals by controlling the entire sales and distribution chain (especially transport). It is intended to prevent counterfeit medicinal products from being introduced into the supply chain or original preparations from being stolen.
Chapter 1.3 of the GDP Guideline states, "The quality assurance system should also cover the control and verification of any outsourced activity related to the procurement, storage, supply or export of medicinal products." Pharmaceutical logistics in this context is the outsourced process of pharmaceutical manufacturers and wholesalers. Thus, the guidelines specify the logistical requirements for storage and transport service providers of pharmaceuticals and must be adhered to by all participants in the supply chain.
EU-GDP Guideline was transferred into German law via the Ordinance on Wholesale and the Distribution of Medicinal Products (Arzneimittelhandelsverordnung - AM-HandelsV). It applies to companies that have a wholesale permit. Section 1a of the Quality Assurance System of the Pharmaceutical Trade Ordinance states: "Establishments and facilities must comply with the EU Guidelines for Good Distribution Practice of Medicinal Products and operate a functioning quality assurance system, for this purpose in accordance with the type and scope of the activities performed, which provides for the active involvement of the management."
Thus, GDP has great significance for pharmaceutical logistics. Although a GDP certificate is not mandatory, it provides competitive advantages through trust. GUTcert carries out an independent certification of your QM system according to the EU-GDP guideline.
GDP is to actors in the distribution chain of pharmaceuticals what GMP is to producers. This means that distributors of pharmaceuticals also assume responsibility for quality by planning logistics in accordance with the quality specifications of the manufacturers, e.g., taking temperature specifications into account and using suitable transport containers.
Within the scope of statutory health insurance, around 749 million packages of prescription drugs were dispensed in 2020 (cold storage fact sheet, ABDA 2021). Of these, around 19.6 million required refrigeration and 11.7 million required cold chain.
Requiring refrigeration means transport at room temperature but refrigerated storage; requiring a cold chain applies to insulin, for example, which must be refrigerated throughout. Refrigeration requirements apply to transprotectors with their own refrigerated vehicles, but also to forwarders who act as transport agents and commission contractors with refrigerated vehicles.
We offer GDP certification for freight forwarders, transport companies, logistics service providers and warehouse keepers operating in the pharmaceutical sector.
As part of the data collection and coordination of your desired certification, you define the scope of your GDP certification.
The scope includes individual warehouse locations or your entire logistics network incl. GDP vehicles and GDP transports.
The scope concerns temperature control, radiopharmaceuticals or time services. The GDP certification can include non-temperature controlled transports and, as an essential factor of the EU-GDP guideline, also temperature controlled transports.
GDP covers the following areas of the value chain according to the outline EU Guideline for Good Distribution Practice:
- Quality Management (Ch. 1)
- Personnel (chap. 2)
- Premises and equipment (chap. 3)
- Documentation (ch. 4)
- Operations (chap. 5)
- Complaints, returns, suspected counterfeit drugs, drug recalls (ch. 6)
- Outsourced/contracted activities (ch. 7)
- Self-inspections (ch. 8)
- Transport (ch. 9)
- Special regulations for intermediaries (ch. 10)
Pharmaceuticals are sensitive goods. High requirements are set for storage and transport: Temperature and humidity control of vehicles and warehouses, up to IT-side networking with cold chain and serial number tracking. If temperature control is not possible, risk assessments must be made, e.g. based on outside temperature, duration of transport, type of transport box and the manufacturer's indication of the temperature sensitivity of the substance.
The focus of GDP audits is therefore on temperature control and on the security of the goods in the process, i.e. the physical securing of shipments by means of mechanical or electronic sealing.
The process of GDP is similar to ISO certifications. We offer you the possibility to link GDP and a certification according to ISO 9001. Details on the GUTcert certification procedure can be found in the overview of GUTcert audit procedures.
In the audit procedure, GDP focuses on on-site inspections in addition to random sample inspections of activities. For example, technical equipment such as cold storage cells, sensor technology, mapping and monitoring; the security of processes, temperature documentation and emergency concepts; the security of goods to prevent theft or the exchange of goods are checked.
After audit completion, the GDP certificate is valid for 3 years. A review audit must be performed once a year to maintain validity.
Costs GDP certification
The costs for a certification according to GDP depend on the activities, the number of sites and the size of the workforce. We will be happy to provide you with an individual offer over a 3-year cycle.
Within the framework of integrated audits, synergies can be generated and audit time expenditures and thus costs can be reduced.
In addition to your certificate, you will also receive our digital certification marks following the audit, which you can use free of charge for your corporate communications.
Three years after (initial) certification, a recertification audit is carried out. In advance, we will provide you with an effort update.
Combination GDP certification with ISO 9001
The GDP guidelines have many similarities with the ISO standards for quality management systems ISO 9001 and ISO 13485. Is your company aiming for certification according to GDP and do you already have a certified quality management system? We would be happy to provide you with a combined offer. With our changeover service, we support you in transferring your existing certification.
As part of the critical infrastructure, special information security requirements also apply to pharmaceutical logistics. GUTcert is accredited for certifications according to ISO/IEC 27001 and carries out KRITIS audits.
Our numerous accreditations enable us to offer you further suitable certifications from the field of logistics and health with little additional effort. The audit effort as well as the costs are significantly reduced when auditing together with neighboring ISO management standards such as environment, occupational safety and energy management.
GUTcert - Your certifier for GDP
What you can expect from us
Competent: Auditors with practical experience and a high level of industry expertise in the field of pharmaceutical logistics. We will find the right auditor for your company.
Fast and uncomplicated: We are the certification body of short distances. Your personal contact person accompanies you from the offer to the certificate handover. With commitment, creativity and conviction, our team is also available to you by telephone for questions at short notice.
Audits with added value: An audit as an examination? We at GUTcert see audits as an opportunity. In addition to checking the GDP requirements, audits offer above all motivation and appreciation for the work of the GDP team. We look at companies holistically and provide impulses for improvements. The positive feedback from our customers confirms this.
Certification as a matter of trust: GUTcert strives for long-term partnerships with its customers, auditors and cooperation partners. Internationally established as well as small and medium-sized companies have been placing their trust in us for years. Please have a look at our references!