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European Regulatory Landscape:
The key regulatory framework pertinent to GDP includes Regulation (EU) 2019/6 and Implementing Regulations (EU) 2021/1248 and 2021/1280. The Regulation 2019/6 aims to ensure that VMPs are manufactured, stored, and distributed in a manner that preserves their quality, safety, and efficacy. Measures of good distribution practices should ensure the identity, integrity, traceability, and quality of active substances used as starting materials in VMPs during their movements from the premises where they are manufactured to the manufacturers of VMPs by means of various modes of transport and by the use of various storage methods, as well as that those active substances remain within the legal supply chain during storage and transport.
Likewise, measures of good distribution practices should ensure the identity, integrity, traceability, and quality of VMPs across the supply chain. Furthermore, those measures should guarantee that veterinary medicinal products are appropriately stored, transported, and handled, as well as ensure that they remain within the legal supply chain during storage and transport.
Each European country has developed National legislation that details the activities that can be performed by the wholesale stakeholders, but the GDP principle must be respected by the parties reported below.
What are Good Distribution Practices (GDP)?
Good Distribution Practices in Veterinary medicines, as in Human medicines, encompass a set of quality assurance standards that apply to the entire distribution chain, from the manufacturer to the end-user. The primary objective of GDP is to safeguard the integrity of VMPs and active substances throughout the distribution process, thereby minimizing risks to animal health and public safety.
Who must be compliant with GDP requirements reported in the Implementing Regulation 2021/1280?
Implementing Regulation (EU) 2021/1280 reports the measures of good distribution practices for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6.
As reported in article 1 (2), GDP for active substances must be respected by:
- Importers of active substances used as starting materials in veterinary medicinal products;
- Distributors of active substances used as starting materials in veterinary medicinal products;
- Manufacturers who distribute active substances, which they manufactured.
Intermediaries of active substances used in veterinary medicinal products do not need to respect GDP principles, as they do not manipulate the products.
Who must be compliant with GDP requirements reported in the Implementing Regulation 2021/1248?
Implementing Regulation (EU) 2021/1248 reports measures of good distribution practices for veterinary medicinal products in accordance with Regulation (EU) 2019/6.
As reported in article 1 (2), GDP for VMPs must be respected by:
- Holders of a manufacturing authorization performing wholesale distribution of the veterinary medicinal products covered by that manufacturing authorization;
- Holders of a wholesale distribution authorization.
What are the main Quality System requirements?
A robust Quality Management System (QMS) is fundamental to quality compliance with GDP. The QMS must be developed taking into account the size, structure and complexity of the activities performed by the company and all parts of the quality system must be adequately resourced with competent personnel, and suitable and sufficient premises, equipment, and facilities.
Establishing and maintaining a comprehensive QMS is essential for ensuring adherence to GDP. This involves defining organizational roles and responsibilities, documenting procedures, and implementing controls to manage risks effectively. With the new regulation inside the organization, it is fundamental to introduce the Quality Assurance role in order to manage and execute all the activities needed.
Personnel Training and Competence: Personnel involved in the distribution of VMPs and active substances must receive adequate training to perform their duties competently. Training programs should cover topics such as product handling, storage conditions, and regulatory requirements. Personnel competences are evaluated to clearly define the roles and responsibilities within the organization.
Premises and Equipment: Distribution facilities must meet specified standards regarding layout, design, and maintenance to ensure the integrity of VMPs and active substances. Adequate storage conditions, temperature monitoring, and sanitation practices are essential for maintaining product quality.
Documentation and Record-Keeping: Accurate and comprehensive documentation is imperative for demonstrating compliance with GDP. This includes maintaining records of product receipt, storage, handling, and distribution, as well as documenting deviations and corrective actions.
Temperature Control and Monitoring: Many VMPs and active substances are sensitive to temperature fluctuations, necessitating strict temperature control measures throughout the distribution chain. Monitoring devices should be employed to track and record temperature conditions during storage and transit.
Transportation and Distribution: Proper handling and transportation practices are critical to prevent product damage or degradation during transit. Vehicles used for transporting VMPs and active substances should be suitable for the purpose and equipped with temperature-control mechanisms where necessary.
Traceability and Product Recall: Effective traceability systems enable rapid identification and recall of VMPs in the event of quality issues or safety concerns. Batch tracking and serialization facilitate traceability throughout the distribution network.
Quality Assurance Tool: The QMS must include the following aspects described in specific SOPs (QA tools) that permit management of the system:
- Document management system;
- Risk management;
- Deviation management;
- CAPA management;
- Periodic reviews;
- Audit and self-assessments;
- Change management;
- Personnel training and qualification;
- Recall management;
- Management of subcontracted activities;
- Management of returned, rejected, recalled or falsified veterinary medicinal products;
- Hygiene principles in the premise and facilities;
- Temperature and environmental controls;
- Equipment management;
- Computerized system management (validation, back-up, restore, data integrity, and business continuity)
Specific distribution process SOPs are described in the regulation as essential for the management of all the activities performed. For VMPs, SOPs are listed in article 18 of the Implementing Regulation (EU) 2021/1248 and for the active substances are listed in article 12 of the Implementing Regulation (EU) 2021/1280.
Compliance and Enforcement:
Regulatory authorities conduct inspections and audits to verify compliance with GDP requirements. Non-compliance can result in regulatory sanctions, including fines, product recalls, and suspension of distribution licenses. To avoid such repercussions, stakeholders must prioritize adherence to GDP principles and continuously improve their quality management systems.
Good Distribution Practices are indispensable for ensuring the quality, safety, and efficacy of veterinary medicinal products throughout the distribution chain. By implementing robust, procedure-based, quality systems and adhering to regulatory requirements, stakeholders can uphold the integrity of VMPs and safeguard animal health and welfare in the European Union. Compliance with GDP not only fulfils regulatory obligations but also instils trust and confidence in the veterinary pharmaceutical industry.
