Quality Control of Formulated Medicines (original) (raw)
Related papers
PloS one, 2018
The circulation of poor quality medicines, especially in the developing countries, is a public health concern. Compliance with good manufacturing practices (GMP) is essential to ensure the quality, efficacy, and safety of medicines. This study evaluated the outcomes of the Brazilian Health Regulatory Agency's (ANVISA) international inspections of two years (2015 and 2016) and compared these to those of other regulatory authorities. The information from 255 inspection reports was analyzed, and the type and extent of deficiencies were collected. In the period evaluated, 62.75% of ANVISA-inspected companies were classified as GMP "satisfactory," 24.71% were classified as having "on demand" status, and 12.55% of inspections concluded that the company did not comply with Brazilian GMP regulations ("unsatisfactory"). The most common areas of deficiency were documentation (28.63%) and premises (26.27%). The pattern of deficiencies was similar to the findin...
Revista de saude publica, 2017
To characterize the technical issues and conditions of medicines conservation in Primary Health Care of Brazilian regions, responsible for pharmacy/dispensing unit profile; environmental, storage, and dose fractioning conditions; inventory control and waste management; fire and electrical failure safety items; transportation problems; advertising regulation; and pharmacovigilance. This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Serviços (National Survey on Access, Use and Promotion of Rational Use of Medicines - Services)-, a cross-sectional and exploratory study, of evaluative nature, consisting of an information survey within a representative sample of municipalities, stratified by Brazilian regions, which constitute the study domains, and a sample of Primary Health Care services. Pharmaceutical services (PS) were directly observed with photographic record and face-to-face interviews with those responsible for the...
Sao Paulo Medical Journal, 2014
CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.
Journal of Radioanalytical and Nuclear Chemistry, 2014
Samples of Enalapril (C 20 H 28 N 2 O 5), a drug largely used to treat hypertension commercialized in Belo Horizonte, Brazil, were analysed applying the k 0-method of neutron activation analysis (k 0-INAA). Medicines prepared according to personalized medical prescription are called manipulated medicines. These analyses aimed at to obtaining complementary data about the quality of the manipulated Enalapril to a survey carried out by the State Health Surveillance Agency of Minas Gerais, Brazil and to determining the presence of impurities in order to perform a preliminary study of the heterogeneity of the samples from each pharmacy. Due to operational reasons, the institutes Centre for Development of Nuclear Technology/ Brazilian Commission for Nuclear Energy in Brazil, and Jožef Stefan Institute in Slovenia analysed different set of samples. The results pointed out the
An overview of established practices and parameters to ensure quality of a pharmaceutical product
2017
ii Abstract The quality of a pharmaceutical product is one of the most challenging considerations of the pharmaceutical industry because it is directly related to the patient health and safety. Every pharmaceutical product should be manufactured by a licensed pharmaceutical manufacturer according to the guidelines, which should be stringently monitored by the licensed pharmacist, in order to attain the target quality product. The guidelines that are followed in the pharmaceutical industry are several, such as the ICH guideline, WHO guideline, FDA guideline, etc. A systematic approach needs to be designed and developed with the ‘end’ in mind, in order to ensure quality where the product and process performance characteristics are scientifically designed to meet specific objectives, not merely empirically derived from performance of test batches. The impact of starting raw materials and process parameters on product quality must surely be well understood, with an emphasis on product a...
International Journal of Pharmaceutics, 2020
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.