GDP (Good Distribution Practices)
Refers to a quality system for warehouses and distribution centers dedicated to medicines.
GDP (Good Distribution Practices) is a set of standards for the sourcing, handling, storage, and transportation of medicines for human use and their active ingredients, these guidelines ensure that the quality and integrity of medicinal products are maintained throughout the supply chain.
The GDP audit shall ensure pharmaceutical products or raw materials in the supply chain are authorized in accordance with legislation, products are always stored in the correct conditions (including during transportation), cross-contamination with other products is avoided, an adequate turnover of stored medicines takes place, and that the correct products reach the correct destination within a satisfactory timeframe.
Last but not least, an auditor can also be an instrument that helps to more easily promote certain changes in the management system for any type of process.
To guarantee the appropriate quality of medicines for end users, it is necessary to comply with the requirements for manufacturing and distribution.
These are covered by standard EU GDP – Good Distribution Practice. Requirements for good distribution practice are based on legal requirements of the Czech Republic (Decree No. 229/2008 Sb., on the manufacture and distribution of medicines) and Guidelines of the European Commission on Good Distribution Practice of Medicinal Products for Human Use (Directive 2013/C 343/01).
Certification for good distribution practice is recommended to all companies involved in the supply chain in the pharmaceutical industry.
Good Manufacturing Practices (GMP):
GMP are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to ensure that their products are consistently high in quality, from batch to batch, for their intended use.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.
Who Needs GDP Certification?
According to the European Medicines Agency, all wholesale distributors of medicines in the European Economic Area (EEA) need GDP certification. Similarly in the UK, anyone that intends to sell or supply medicines to someone other than the end-user needs GDP certification.
In the European Union (EU), a GDP certificate is issued by the competent authority when the inspection has officially ended or 90 days since the last day of the inspection, provided that nearly all areas are GDP compliant.
Good distribution practice in the UK is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). Unlike in the EU, the GDP certificate is only given when the MHRA inspector accepts the distributor’s response to the post-inspection letter.
Quality System/Quality Management
A quality system should have the organizational structure, procedures, processes, resources, and actions needed to demonstrate that the distributor meets quality requirements. Quality management or the quality system must include a documented quality policy as well as authorized procurement and release procedures.
Wholesalers are also required to assess potential risks to the quality of products and follow quality risk management principles. Quality systems should be regularly reviewed and revised according to the recommendations of the risk assessments conducted.
Personnel
Management must appoint a responsible person whose duties include all the activities necessary for GDP compliance, such as implementing and maintaining the quality system.
The responsible person (also known as the qualified or designated person) is tasked with overseeing the organization’s GDP training programme. Initial and refresher GDP training is required for all personnel involved in distribution and should cover the following topics:
Product security
aspects of product identification
detection of falsified medicines
avoidance of counterfeits entering the supply chain
The distributor must keep a record of all GDP training and routinely evaluate its effectiveness in promoting good distribution practices throughout the organization.
Supplier & Customer Qualification
Wholesalers need to check if a potential supplier has a wholesale distribution authorisation or a wholesale dealer licence before selecting them. Due diligence checks have to be performed and include observations on the following:
the reputation or reliability of the supplier
the likelihood that the pharmaceutical product offered is falsified
the quantity of the pharmaceutical product offered, especially if typically it is only available in smaller quantities
out-of-range prices
Additionally, wholesalers should only accept orders from customers with wholesale distribution authorisations, wholesale dealer licences, or are authorised to supply medicines to the public.
Storage
In general, warehouses should be clean, dry, and free from vermin. The temperature and humidity levels in storage areas should be within acceptable ranges. As much as possible, products must be kept off the floor and away from direct sunlight. There should be separate storage areas for the following:
returned products
broken or damaged products
recalled products
suspected counterfeits
hazardous products
Distributors also need to establish precautions against unauthorized access to the premises and prohibit food, drink, smoking material, and personal medication from storage areas. Additionally,
they must ensure that warehouses have adequate cleaning and pest control programmes.
Though the First Expired First Out (FEFO) principle is recommended, exceptions to the principle are allowed as long as they are documented and no expired stock is distributed.
Warehouse managers need to conduct regular stock inventories, comparing the actual and recorded stocks. Any stock discrepancies or irregularities should be documented and investigated.
Transportation
Before dispatch, the wholesaler must first confirm that the delivery order is valid or that there is a documented material replenishment plan for the customer. After confirmation, the medicines are to be placed in a shipping container with a label that describes the handling and storage requirements and precautions, as well as the contents of the container and its source.
Once labeled, the shipping container can be loaded onto the vehicle at the appropriate time, according to the delivery schedule. It is important to remember that the quality, integrity, and security of the medicines during transit is still the responsibility of the wholesaler.
Therefore, the wholesaler must establish measures and protocols which ensure the following:
medicines are not damaged or contaminated while in transit
required storage conditions are maintained throughout transit
vehicles and medicines within those vehicles are protected against theft
If a deviation from any of the above occurs during transportation, the vehicle operator must report it to the wholesaler and to the intended recipient.
Documentation
Documentation should be sufficient enough to enable complete traceability of medicinal products across distribution channels. All parties involved have to be readily identifiable. Here are the requirements for documentation concerning the distribution of medicinal products:
Clearly stated title, nature, and purpose
Dated and approved by an authorised person
Not changed without the necessary authorisation
All documents and records (such as that for dispatch and receipt) must be kept for 7 years, unless otherwise stated by the national or regional authority.
Complaints, Returns, Recalls
Complaints are to be divided into two categories: (1) those relating to the quality of the product and (2) those relating to its distribution. For quality complaints, the wholesaler is required to immediately inform the manufacturer or manufacturing authorisation holder. For distribution complaints, the wholesaler must conduct a thorough investigation to identify what’s causing the issue mentioned in the complaint.
For returns, the wholesaler has to perform an assessment that takes into consideration the following before adding the product back into saleable stock:
nature of the returned product
any special storage conditions required
condition of the returned product
its history and time elapsed since issue
However, if the returned product was a stolen product, it cannot be added back into saleable stock.
In the event of a recall, the wholesaler needs to inform the following supply chain stakeholders:
manufacturer or marketing authorisation holder
regulatory authorities in the country or region of the wholesaler
customers and authorities of countries to which the products may have been distributed
The wholesaler must also record the progress of the recall and issue a final report that includes reconciliation between delivered and recovered quantities of products.
Falsified Medicines/Counterfeit Pharmaceutical Products
The distributor has to immediately notify the competent authority and the marketing authorisation holder upon identifying or suspecting a medicinal product to be falsified. The sale and distribution of suspected counterfeit medicines should be suspended. These products are to be stored separately from other products and labeled as falsified and not for sale.
When it has been confirmed that the pharmaceutical product is a counterfeit, a formal decision must be made regarding its disposal. The distributor is required to take steps to ensure that counterfeits do not re-enter the supply chain or end up together with saleable stock.
Self-Inspections
A key requirement of good distribution practice is a self-inspection programme. The scope of self-inspections can vary. The wholesaler may decide that a comprehensive self-inspection performed less often is better than smaller, more specific self-inspections performed regularly. However, regardless of the scope, each self-inspection should:
be performed in an impartial and detailed manner; and be completed by a designated competent company personnel.
The results of each self-inspection must be recorded in a report that notes the observations made during the inspection. Any form of non-compliance, deficiency, or irregularity must be investigated and their root cause/s identified. The wholesaler also needs to establish, document, and follow-up on corrective and preventive actions (CAPA).
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