Good distribution practice
Good Distribution Practice (GDP) Good Distribution Practice (GDP) is a part of the quality assurance process that ensures that the quality of medicines is maintained at all stages of the supply chain, from the place of manufacture to the pharmacy or the person authorized to supply medicinal products to the general public. GDP requirements are laid down in in Good distribution practice guide in regard to distribution of human medicinal products of 5 November 2013 (GDP Guide); wholesale distribution authorisation holders are obligated to follow the guide by the point G, Article 80 of the Directive 2001/83/EC transposed into part 2, Article 30 of the Law on Pharmacy of the Republic of Lithuania and into the Order No. V-524 of the Minister of Health of the Republic of Lithuania „Regarding performance of pharmaceutical activity according to the good distribution practice of medicinal products“ which abolished the rules of Good Distribution Practices that existed before. According to Article 2 (5) of the Law on Pharmacy, wholesale distribution of medicinal products is an activity involving the procurement, holding, supply or export of medicinal products, unless such action is carried out for the purpose of selling or dispensing medicinal products to the general public or patients. The GDP guidelines define procurement as a receipt or purchase, and therefore the purchase and sale of medicinal products without actually requiring them to be received and stored is a wholesale distribution activity requiring a license. It also does not matter where the distributor is established (in specific parts of the customs territory, such as free zones or free warehouses) and operates (stores, supplies or exports), the requirements to have a wholesale distribution authorisation and to operate under GDP are applied to the distributor. Persons who deal with the mediation of medicinal products on the territory of the Republic of Lithuania, who have their place of residence and / or place of work and contact persons in accordance with Article 341 of the Law on Pharmacy, are registered by listing them on the List of Brokers. They must act in accordance with the relevant requirements of the GDP guidelines. The GDP Guide specifies the requirements for the quality system, personnel, premises and equipment, documentation, operations performed (for the selection and validation of suppliers, for the assessment of recipients, the acceptance, storage, stock management, supply, including transportation, for export to third countries), for handling complaints, suspected counterfeits, returns and cancellations, contractual activities, internal audits, implemented by the wholesale distribution authorisation holder The GPP guidelines recommend the use of the ICH Q9 Quality Risk Management guidelines for quality risk management, as recommended by the International Conference on the Harmonization of Technical Requirements for the Registration of Medicinal Products for Human Use. As the basic principle of quality management of the GDP guidelines obliges all critical stages and significant changes to be identified, justified and, where appropriate, validated, the wholesale distribution authorisation holder must apply the premises and equipment qualification and process validation principles as set out in Annex 15, "Qualification and / Validation "for computer systems - Appendix 11," Computer Systems ". More detailed instructions on how to design, install and qualify premises, equipment, auxiliary systems, assess computer system risks and validate them, manage the cold chain, etc. can be found in the International Pharmaceutical Engineering Association (ISPE) documents used by the pharmaceutical manufacturers in implementing technical GMP requirements. Active substances may be imported from third countries and distributed only by individuals who are listed on the SMCA list of manufacturers, importers and distributors of active substances and who operate in accordance with good distribution practices for active substances. http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm Useful links: www.ec.europa.eu/health/files/gdp/2014-04_qas_.pdf
® www.ich.org/home.html GDP Certificates Good Distribution Practice Certificate (GDP certificate) – is a document issued by the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (hereinafter referred to as the SMCA), which confirms that the pharmaceutical activity carried out by the holder of a wholesale distribution authorisation meets the requirements of the GDP on the basis of the final conclusion of inspection of this activity. The compliance with the GDP is evaluated and the relevant conclusions are drawn by the GDP Inspectors of the SMCA Inspection Unit in accordance with the requirements of the Order No V-726 of the Minister of Health of the Republic of Lithuania of 3 July 2014 approving the description of the order of inspections in regard of compliance to the requirements of good distribution practice of wholesale distribution authorisation holders and distributors / importers of active substances and taking into account the Compilation of Community procedures on inspections and exchange of information. GDP certificates are issued not later than within 90 days from last day of periodic general GDP inspection, which reveals that the wholesale distribution authorisation holder complies with GDP requirements. GDP certificates shall not be issued on the basis of the inspection carried out to assess the readiness of the applicant for a wholesale distribution authorisation to carry out the foreseen pharmaceutical activities at the indicated site. In this case, compliance with good distribution practice is confirmed by the wholesale distribution authorisation. If necessary, at the written request of the holder of the wholesale distribution authorisation, the SMCA may prepare an information letter regarding the wholesale distribution authorisation granted to the company, the on-site inspection and its conclusions. GDP certificates are issued, amended, revoked, revised, their information and data are published in accordance with the requirements of the Order No. V-726 of the Minister of Health of the Republic of Lithuania of 3 July 2014 regarding approval of the description of the order on granting of Good Distribution Practice certificates. According to the procedure established by the European Commission, the data of pharmaceutical wholesale distribution authorisations, GDP certificates and the non-compliance with GDP requirements for each EU Member State are published in the EudraGMDP data base of the European Medicines Agency: http://eudragmdp.eudra.org Valid Lithuanian Good Distribution Practice (GDP) Certificates
|
| Last Update: 2019-06-11 10:03:55 |
Last updated: 23-11-2023