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".
Conditions and evidence
- Status and registration Authorisation for manufacturing medicinal products that includes analytical testing of medicinal products Certificate of good manufacturing practice
- Medicinal Products Act
- Rules on the conditions to be met by analysts in analytical testing of medicinal products for human use and veterinary medicinal products and procedure for the verification of these conditions
- Rules on analytical, pharmacological- toxicological and clinical testing of medicinal products for human use
- Rules on method and procedure of the analytical, pharmacotoxicological and clinical testing of veterinary medicinal products
- COMMISSION DIRECTIVE 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products
- RECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL