Informative Notice
Certain content is still being edited. Thank you for your understanding.
Analytical testing of medicinal products
Before a medicinal product is placed on the market, it must be analysed, non-clinically pharmacologically and toxicologically and clinically tested in order to assess its quality, safety and effectiveness. A medicinal product is also tested analytically, non-clinically pharmacologically and toxicologically and clinically when it has already obtained a permit for placement on the market or when it is already placed on the market if the test is in order to acquire additional data about the product or because of quality control of the product.
Analytical testing of a medicinal product is microbiological, chemical/physical and biological testing of the quality of the product in accordance with principles and good production practice.
The analytical testing of a medicinal product is intended to acquire data on the pharmaceutical development of the product that defines the control of ingredients of the product, capsule and final product, adequacy of production procedures and stability of substances and final product.
Analytical testing of medicinal products relates to the following activities:
- final quality control of medicinal products;
- quality control of starting materials and excipients;
- process quality control of medicinal products;
- all validation activities on the basis of documentation for the acquisition of a permit to trade in medicinal products (validation of analysis methods, process validation, validation of cleaning);
- stability studies on the basis of documentation for the acquisition of a permit to trade in the product;
- quality control of the environmental conditions in sterile production.
Analytical testing of medicinal products is carried out by business entities which have a permit for the production of such products, which includes the activity of analytically testing them.
The manner and procedure of analytical and pharmacological and toxicological testing of products for human use and the content of documentation on the quality, safety and effectiveness of a medicinal product are determined in the Annex to Commission Directive 2003/63/EC of 25 June 2003 amending directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (L No 159 of 27 June 2003, page 46) and in the Annex to Directive 2009/120/EC.
Detailed guidelines and the content of the documentation referred to in the previous paragraph are published in the guidelines adopted by the European Commission: "The Rules Governing Medicinal Products in the European Union, Volume 3 – Medicinal Products for Human Use: Guidelines".
Applies for SKD:
- Technical testing and analysis M71.200
Conditions
-
Applicants who wish to pursue this activity must register the business activity, and have the appropriate legal status.
-
The medicinal products are analysis-tested by business entities with the authorisation for manufacturing medicinal products that also includes analytical testing of medicinal products.
Examiners must fulfil the conditions for acquiring the authorisation for analytically testing medicinal products, i.e. with regard to staff, premises, equipment and good practices principles determined in the regulation that determines specific conditions for manufacturing medicinal products and establishing the fulfilment of these conditions and on the procedure of publishing or withdrawing the certificate on the implementation of good manufacturing practice.
The authorisation for analytically testing medicinal products is issued within the authorisation for manufacturing medicinal products.
Detailed instructions which the medicine examiners for analytical testing of medicinal products must fulfil are published in the Rules governing medicinal products in the European Union, Volume 4 – Good manufacturing practice, including all amendments adopted by the European Commission which are published on the Eudralex website.
The authorisation includes the manufacture of medicinal products and their sale to wholesalers of medicinal products and must be acquired for:
- individual manufacturing sites,
- individual manufacturing activities,
- individual pharmaceutical forms
- and the import of medicinal products from third parties.
The application for the acquisition of the authorisation for manufacturing medicinal products is submitted by the application to the agency in printed and electronic form.
The general part of the application encompasses the following data and documents:
Letter indicating:
- the full and shortened name and head office of the applicant, stating all locations where medicinal products are manufactured;
- activities of the applicant subject to the procedure for the issue of the authorisation for manufacturing medicinal products;
- name and surname of the responsible person and signature of the responsible person;
Documentation:
- the list of persons who work as manufacture and control managers or other persons who take over responsibilities determined in the second chapter of good manufacturing practice;
- evidence on the availability of the person responsible for launching an individual lot of medicine and who is constantly accessible and fulfils the prescribed conditions, evidence on their professional education and appropriate work experience;
- written statement of the applicant to enable the responsible person under the previous item independent performance of duties and that it has all required means;
- written statement of the applicant that they will manufacture medicinal products in accordance with the guidelines and principles of good manufacturing practice;
- written statement of the applicant that they will use only active substances manufactured in accordance with good manufacturing practice;
- written statement of the applicant that only medicinal products manufactured within the activities under the manufacture authorisation will be ensured in accordance with regulations.
The expert part of the application contains information from the applicant on fulfilling expert requirements. The applicant states information in the scope that applies to the scope of their work processes for the manufacture of medicinal products.
The expert part of the application can be replaced by an appropriate internal document of the applicant which contains the prescribed data.
The applicant states data and documents in the expert part which are determined in the Annex to the Rules on conditions for completing activities of making medicinals and determining of conditions and procedure of publishing or revocation of execution of good production practices.
-
The holder of the authorisation for the manufacture of medicinal products can require a confirmation or certificate on good manufacturing practice (GMP certificate) from the authority competent for medicinal products. The certificate on the implementation of good manufacturing practice can be issued based on the performed special fact-finding procedure within the scope of the authorisation issue or performed control of the fulfilment of conditions for the manufacture of medicinal products at the holder of authorisation.
The certificate on good manufacturing practice is issued by the pharmaceutical inspector to the inspected business entity ex officio within 90 days from the date of inspection, if it is found that the business entity manufactures medicinal products or active substances in accordance with the good manufacturing practices principles and guidelines or within 15 days from the issue of modification of the authorisation for manufacturing medicinal products or the entry or the modification of the entry in the register of manufacturers of active substances.
The certificate on good manufacturing practice is issued on a form in Slovenian and English languages as stipulated in the Compilation of Community Procedures.
The certified application lodged by the holder of the authorisation contains:
- full and short name and address of the applicant;
- the number of the authorisation for manufacturing medicinal products;
- location and activity from the authorisation for which the applicant requests a certificate;
- the number of existing certificates for such activities.
The certificate contains only the information on the conformity of the applicant's activities in the scope of the supervision which is the basis for the issue of the certificate.
The validity of the certificate is usually three years. The validity can be shortened based on the opinion of the pharmaceuticals supervisor.