Quality of medicines: Deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections (original) (raw)
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2021
The prevalence of substandard medicines in Africa is high but not well documented. Low and Middle-Income Countries (LMICs) are likely to face considerable challenges with substandard medications. Africa faces inadequate drug regulatory practices, and in general, compliance with Good Manufacturing Practices (GMP) in most of the pharmaceutical industries is lacking. The majority of pharmaceutical manufacturers in developing countries are often overwhelmed by the GMP requirements and therefore are unable to operate in line with internationally acceptable standards. Non-conformances observed during regulatory inspections provide the status of the compliance to GMP requirements. The study aimed to identify the GMP non-conformances during regulatory inspections and gaps in the production of pharmaceuticals locally manufactured in Uganda by review of the available 50 GMP reports of 21 local pharmaceutical companies in Uganda from 2016. The binary logistic generalized estimating equations (...
BMJ global health, 2018
The rapid globalisation of the pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private pharmaceutical distributors. This descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private pharmaceutical distributors in 13 LMICs. We assessed the distributors' compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines 'Model Quality Assurance System (MQAS) for procurement agencies'. Descriptive statistics describe the compliance for the whole sample, for distributors in sub-Saha...
BMJ Global Health, 2020
Introduction Access to quality-assured medicines is an essential prerequisite for universal health coverage, and pharmaceutical distributors play an important role to assure the quality of medicines along the supply chain. Methods We retrospectively assessed the compliance with WHO quality standards, that is, the Model Quality Assurance System for Procurement Agencies (MQAS) or the good distribution practices (GDP), of a convenience sample of 75 public, private-for-profit and non-for-profit distributors, audited by QUAMED in 14 low-income and middle-income countries (LMICs) between 2017 and 2019. We calculated the compliance per quality assurance activity, and we defined the percentage of compliant distributors, that is, the percentage (%) of distributors with MQAS or GDP levels of >2 for each activity. Results The distributors in our sample were mainly private for-profit (66/75). Only one MQAS-audited distributor out of 11 was found compliant with all MQAS-activities, while none...
Influence of manufacturing practices on quality of pharmaceutical products manufactured in Kenya
East African Medical Journal, 2004
, equipment, and staff. That administered to the pharmacy outlet included availability, affordability and acceptability of locally manufactured pharmaceutical products. Quality analysis of products involved the establishment of the chemical content, dissolution profile, friability, uniformity of weight and identity. For antibiotic suspensions the stability after reconstitution was also determined. Results: There were 15 respondents and two non-respondents from the industry and six out of nine respondents from the pharmacy outlets. The ratio of qualified staff to product range produced seemed to influence product quality. Industries producing several products with only limited number of pharmaceutical staff had more products failing to comply with pharmacopoeia specifications compared to those producing only few products. Nevertheless, all companies are well equipped with quality control equipment, in accordance with type of product manufactured. Private pharmacies stocked few of the locally manufactured products. The reason, they said, was due to low doctor and/or patient acceptance. Compliance with quality specifications as set out in respective monographs was overall 76%. Conclusion: Although the local pharmaceutical industries have adopted good manufacturing practices leading to many good quality products currently in commerce, these manufacturing practices are not comprehensive and measures need to be taken to continue improving them.
Cost Effectiveness and Resource Allocation, 2022
Background: Afghanistan, a low-income landlocked country, is continuously suffering from domestic war and conflicts; the country struggles to provide quality healthcare services, including affordable medicinal products in the required quantity. Moreover, the quality standards of domestic pharmaceutical companies have not been established yet. One of the internationally recognized guidelines for monitoring manufacturing processes in pharmaceutical companies is Good Manufacturing Practice (GMP), recommended by World Health Organization (WHO). Therefore, this study aimed to assess whether a pharmaceutical company in Kabul, Afghanistan adheres to the GMP standards established by WHO. Method: A descriptive cross-sectional study was conducted to assess the WHO-delineated GMP compliance of 25 pharmaceutical companies in Kabul, Afghanistan. The inspection checklist was developed by Afghanistan's National Medicine and Healthcare Products Regulatory Authority (NMHRA) using the WHO-delineated GMP guidelines. In addition, direct observation, interviews with respective delegates, and documentation reviews were conducted to collect research data. Result: Only 38.33% (1.14 ± 1.08) of GMP contents were complied. Personnel 66.67% (2 ± 1.15) and materials 58.67% (1.76 ± 1.11) were the most commonly complied components, whereas the product recall 12.98% (0.39 ± 0.85), quality assurance 16.44% (0.49 ± 0.81) and quality control laboratory 28.35% (0.85 ± 1.12) were the least complied ones. Conclusion: None of the GMP components was fully adhered to by the pharmaceutical companies in Kabul, Afghanistan. Quality control and assurance should be implemented immediately, including validation and qualification practices.
2006
A study was done to examine the drug quality in USAID-assisted countries. In Cameroon 284 samples of three antimalarial drugs from 132 different sources in 16 villages and cities throughout the country were collected. Drug quality was assessed by a simple color reaction test and semi-quantitative thin-layer chromatography. Fifty (38%) of 133 chloroquine 52 (74%) of 70 quinine and 10 (12%) of 81 antifolates had either no active ingredient an insufficient active ingredient the wrong ingredient or unknown ingredient(s). In the Congo Fake antiretrovirals were found in Lubumbashi in December 2003. The bottles and blisters which were not in carton boxes were labeled "Triomune" (stavudine lamivudine and nevirapine) and "Duovir" (lamivudine and zidovudine) both of which are Ciplas brand products. Preliminary investigations showed that fake labels were put on bottles containing non-ARV pharmaceutical products. Some tablets have been identified to contain fluvoxamine (anti...
Drug Information Journal, 1997
To facilitate use of the World Health Organisation (WHO) Certification Scheme, a set of guidelines was developed in 1996, which includes model certificates for use by Member States. Today, the scheme provides transparent information, particularly about the regulatory status of a product in the exporting country. If used properly, the product certificate and batch certificate can provide a basis for product registration. This article covers the strengths and weaknesses of the scheme.