Proprietary medicinal products controls

Committee For Proprietary Medicinal Products, Xotes to Applicants for Marketing Authorisations on the Production and Quality Control of Monoclonal... 

European Medicines Agency—Committee for Proprietary Medicinal Products. Guideline on the Evaluation of Control Samples In Nonclincial Safety Studies Checking for Contamination with the Test Substance. CPMP/SWP/1094/04. 17 March 2005. http //www.emea.europa.eu/pdfs/human/swp/109404en.pdf... 

BVA/FrAME/RSPCA/UFAW Working Group of Refinement (1993) Removal of blood from laboratory mammals and birds. Faboratory Animals 27 1-22 Cayen MN (1995) Considerations in the design of toxicokinetic programs. Toxicol Pathol 23(2) 148-157 CPMP Position paper (2004) Committee for proprietary medicinal products (CPMP) Position paper/guideline on the toxicokinetic evaluation of control samples in toxicology studies... 

Committee for Proprietary Medicinal Products (1991). EEC Regulatory Document Note for Guidance Production and quality control of cytokine products derived by biotechnological processes. Biologicals 19, 125-131. 

The manufacturer s chemical and pharmaceutical files are examined and product conformity is controlled at the registration level. Such an operation is carried out through the DPM with a goal of acquiring an MA for the appropriate proprietary medicinal product. 

Any application for granting or assigning an MA inherent to an imported proprietary medicinal product shall be accompanied with due justification of fee payment amounting to Tunisian dinars 1,200 for the benefit of National Laboratory of Drugs Control. The said fees are reduced to Tunisian dinars 600 if the application concerns the authorization renewal. Fee payment is settled in convertible currency equivalent to the said amount. 

The consequences for the scientific assessment of study validity did induce the European Medicines Evaluation Agency and its Committee for Proprietary Medicinal Products (EMEA/CPMP) to issue a draft guideline to deal with this problem of control sample contamination (CPMP, 2004). In this draft guideline reference is made to the GLP Principles and their requirement of fully, and truthfully, representing all results from a study, and the guideline stresses what is required for a GLP-compliant study report as follows The contamination of control samples with the test compound in toxicology studies shall be reported appropriately within a GLP statement as a deviation or violation. Contamination of controls should also be clearly acknowledged in the study reports and discussed by the Study Director with respect to its impact on the validity ofthe study. ... 

For control of the finished product, the following definition has been given in Directive 75/318/EEC For the control of the finished product, a batch of a proprietary medicinal product comprises all the units of a pharmaceutical form which are made from the same initial mass of material and have undergone a single series of manufacturing operations or a single sterilisation operation or, in the case of a continuous production process, all the units manufactured in a given period of time . 

In the same period, vendors of proprietary medicines took advantage of our love of the natural to peddle a variety of plant-derived products. These were advertised as safer and more pleasant than those typically employed by physicians. For example, Mrs. Winslow s Soothing Syrup and Kopp s Baby Friend had morphine sulfate as their basic ingredient. Hostetter s Bitters was a 78 proof (39% ethanol) cocktail. This theme is being replayed currently as alternative medicine. This time around, controlled clinical trials are being carried out, slowly, to establish what works and... 

Lewis JA, Jonsson B, Kreutz G, Sampaco C, van Zwieten-Bwot B. Placebo-controlled trials and the Declaration of Helsinki Committee on Proprietary and Medicinal Products. BrJ Clin Pharmacol 2001 52 223-9. 

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