Committee for Proprietary Medicinal Products CPMP

The reader may wonder why process validation is included. This is simply a matter of consideration of the content of guidelines issued in the past that relate to development pharmaceutics. The first such pan-European guideline, adopted by the Committee for Proprietary Medicinal Products (CPMP) in 1988, included advice on both development pharmaceutics and process development. Later versions of the guidelines on development pharmaceutics and on process development have addressed these topics separately, but the historical and practical perspectives suggests that both need to be discussed here. 

Committee for Proprietary Medicinal Products (CPMP). Note for Guidance on Repeated Dose Toxicity (CPMP/SWP/1042/99). October 2000. 

The Committee for Proprietary Medicinal Products (CPMP) within the European Agency for the Evaluation of Medicinal Products (EMEA) has also issued a Note for Guidance on the pharmacokinetic and clinical evaluation of mod-ified-release oral products, which provides some information on the development and evaluation of an IVTVC (5). 

Ten years later, three directives sought to further promote public health and the free movement of medicinal products within the community. Directive 75/318/EEC [2] set analytical, pharmacotoxicological, and clinical standards for testing proprietary medicinal products, Directive 75/319/EEC [3] established the Committee for Proprietary Medicinal Products (CPMP) and its partial mutual recognition procedure, whereas Directive 75/320/EEC [4] established a Pharmaceutical Committee to examine problems in implementing the pharmaceutical directives. 

The principal scientific bodies of the EMEA are the Committee for Proprietary Medicinal Products (CPMP) and the Committee for Veterinary Medicinal Products (CVMP). These committees have two members from each member state as well as from Norway and Iceland which are appointed to give independent scientific advice to the EMEA. 

The present guidance does not lay down detailed requirements for specific classes of biological products, and attention is therefore directed to other guidelines issued by the Committee for Proprietary Medicinal Products (CPMP), e.g. the note for guidance on monoclonal antibodies and the note for guidance on products of recombinant DNA technology The Rules Governing Medicinal Products in the European Community, Volume III). 

At this stage the guideline or recommendation embodying the scientific consensus leaves the ICH process and becomes the subject of regulatory consultation in the three parts of the world. In the European Union, it Is published as a draft Committee for Proprietary Medicinal Products (CPMP) Guideline, in the United States, it is published as a draft guidance in the Federal Register, and in Japan, it is translated and issued by MHLW, for internal and external consultation. 

As if there needed to be more affirmation regarding the inclusion of data on validation in the application, the EMEA issued the Note for Guidance on Process Validation [40] prepared by the Committee for Proprietary Medicinal Products (CPMP). This came into operation in 2001. 

The use of vertebrates to evaluate tolerability and absorption of drug administered via the vaginal route has been widely criticized on the basis of scientific and ethical considerations. Studies on animals can be substituted by validated in vitro tests as described in the guideline issued by Committee for Proprietary Medicinal Products (CPMP), now Committee for Medicinal Products for Human Use (CHMP) [112], Before an in vitro test can be considered valid, this test must undergo a procedure aimed at establishing its relevance and reliability. The relevance of the alternative test has to be compared with accepted in vivo standard methods. 

The efforts to develop a harmonized system concerning direct safety, efficacy, and quality go back to 1965, when the first harmonized directive was issued [95]. Ten years later, the Committee for Proprietary Medicinal Products (CPMP) was established [96]. In 1989, the International Conference on Flarmonization (ICFI) was founded, and the EMEA began operation on January 1,1995 [97]. The EMEA serves as an advisory board, but is responsible for coordinating the approval, manufacturing, and inspection of medical products between the CPMP and member states regulatory bodies [98]. 

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... 

The Committee for Proprietary Medicinal Products (CPMP) guideline calls for a full explanation and justification for including antioxidants in the formu-lation. It further states that antioxidants should only be included in a formulation if it has been proven that their use cannot be avoided. Thus, it is imperative to first try inert gas (nitrogen or argon) in the head-space to prevent oxidation. If the antioxidant has to be included, its concentration must be justified in terms of efficacy and safety. Antioxidants such as sulfites and metabisulfites are especially undesirable. 

A major issue in performing virus validation studies is determining which viruses should be used. The Committee for Proprietary Medicinal Products (CPMP) has issued guidelines on the selection of viruses to evaluate in validation studies. Processes must be validated for their capacity to inactivate/remove relevant viruses, or viruses that are known to contaminate plasma or other materials in the production process. If relevant viruses cannot be easily propagated in cell culture or assayed, then validation studies should include specific model viruses with characteristics similar to relevant viruses. If relevant viruses do not represent viruses with... 

Assignment of Documentation and Finished Product. Documentation and samples of finished products are sent to the evaluation unity. The evaluator excim-ines the technical file with reference to different current pharmacopoeia, i.e., the European Pharmacopoeia to which commission Tunisia is adherent as an observer, the American Pharmacopoeia, the British Pharmacopoeia and to the documents issued by the International Conference of Harmonization (ICH), to the guidelines of the World Health Organization (WHO), to the decisions taken by the European Committee for Proprietary Medicinal Products (CPMP) and to a set of bibliographic references. 

MAs and variations thereto follow the requirements of the Europecm Directives in all respects. Assessment and legal procedures are carefully constructed to be in compliance with the European legislation and guidelines of the Committee for Proprietary Medicinal Products (CPMP). Data requirements and presentation format follow those laid down by Directives. Advice on planned applications can be sought from the MCA, and this is particularly recommended in the case of applicants planning to make use of the European Mutual Recognition Procedures. 

In 1997, the Committee for Proprietary Medicinal Products (CPMP) of the European Union issued a "points to consider" document4 on the assessment of the potential for QT interval prolongation by noncardiovascular medicinal products. The CPMP document was followed by the Canadian draft in 2001, the Health Canada/USA draft in 2002, and the International Conference on Harmonization on preclinical guidelines (ICH) S7A (in vivo)5 and S7B (in vitro).6... 

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