Résumé
From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distri-bution,batch-to-batch difference and abnormal quality probability.After that rules for risk assessment were established based on the SPC limitations and parameters.Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality.Finally,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend tracking.The strategy demon-strated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production processes.In addition,a process risk assessment and population quality trend tracking provide data-based information for approval.Not only can this information serve as a further basis for decision-making by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse reactions.With continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.
Résumé
In order to promote the effective butt joint between professional construction and region biopharmaceutical industry construction,the article discusses the professional construction of higher vocational pharmaceutical quality and safety program from four aspects:talent training objectives,job capability,curriculum system,and teaching faculty.This article establishes the objectives of training high-quality applied talents for the bio-pharmaceutical industry,analyzes the quality requirements of the core post group,discusses the construction of the core curriculum system based on typical work tasks,and how to build the "Double Qualification Double Ability" faculty.
Résumé
OBJECTIVE:To promote effective supervision of key monitoring drugs by provincial pharmaceutical quality control center,and to improve rational drug use. METHODS:The effects of No.2 district of Sichuan province pharmaceutical quality con-trol center on 3 categories of key monitoring drugs guidance and supervision,through urging medical institution in the area to estab-lish key monitoring drugs supervision system,formulating prescription review guideline for 3 categories of key monitoring drugs [TCM injection,adjunctive drug,proton pump inhibitors (PPIs)],developing baseline data survey,inspecting the application of key monitoring drug in medical instaurations on the spot and other measures,were introduced. Through collecting the reports of re-gional quality control center to the provincial quality control center,supervision system of medical institutions were analyzed statisti-cally. Key monitoring drugs of medical institutions in the area were analyzed statistically in respects of rational utilization ratio,uti-lization quantity,utilization amount,etc.,so as to evaluate supervision effects. RESULTS:Up to Apr. 2016,92.26%medical insti-tutions had been aware of the relevant requirements of the documents;84.25% had established the hospital supervision system. 3 categories of key monitoring drugs prescription(orders)comment guideline had been developed in Mar. 2016. 18 third-grade class-A general medical institutions were randomly selected;among 3 categories,irrational utilization ratio of TCM injection decreased by 12.35%(35.41% vs. 47.76%);that of adjunctive drugs decreased by 9.64%(20.95% vs. 30.59%);that of PPIs decreased by 7.44%(40.49% vs. 47.93%) in May 2016,compare to Jan. 2016. Average consumption sum of them decreased by 12.07%, 13.30%,9.49%,respectively in Apr. 2016,compared to Jan. 2016. 55.02% medical institutions had started to collect the baseline data. CONCLUSIONS:The provincial pharmaceutical quality control center has played an important role on establishing a supervi-sion system,it can promote the effective supervision by guiding and supervising the medical institutions evaluating the supervision of medical institutions and pointing out the problems.
Résumé
In recent times the apparent upsurge in the popularity and use of herbal medicines can be related to the success in their use for the management of certain important diseases, empirical proof of efficacy and safety, enhanced dosage form design and better tolerance among others. In this study the quality of some herbal medicines sold in Nigeria were evaluated for basic pharmaceutical quality and compliance to regulatory guidelines. Samples of sixteen frequently used herbal products were collected from Pharmacy stores (Ps) and Patent Medicine stores (PMs) across two states and the Federal Capital Territory. The dosage form, organoleptic properties, moisture content, weight/volume uniformity as well as compliance to regulatory guidelines were evaluated. Sixty percent of the samples were liquids, thirty percent were oral bulk powders and ten percent were capsules. None of the products complied completely with the regulatory requirement stipulated for finished herbal products in Nigeria while only ten percent of the products samples complied with the basic physicochemical properties required for pharmaceutical quality. Consequently, there is a compelling need for the regulatory authorities to ensure stringent quality surveillance and enforcement of guidelines to ensure that herbal medicines are of standard quality.
Résumé
OBJECTIVE: To analyze the key problems in the management of drug production process changes during the drug life cycle, thus to improve the management of pharmaceutical production process changes. METHODS: Taking the change of injection sterilization process as an example, the issues in the study and management of process change were analyzed by employing empirical a-nalysis methods and introducing the concept of equilibrium analysis of the pharmaceutical quality system. RESULTS AND CONCLUSION: The pharmaceutical quality system is the equilibrium system of five aspects, including prescription composition, raw material control, production process, packaging and quality control. Process change research should follow the concept that quality comes from design, use process analytical technologies, and give full consideration to the quality system equilibrium. Process change management needs a systematic management of drugs.
Résumé
O setor magistral representa um importante segmento do mercado brasileiro de medicamentos. Entretanto, a qualidade dos produtos fornecidos pelos estabelecimentos é frequentemente discutida e a Agência Nacional de Vigilância Sanitária (ANVISA) tem demonstrado uma preocupação com os produtos magistrais, pela promoção de consultas públicas abordando o assunto e pelo aumento do rigor nas legislações específicas. Assim sendo, as farmácias magistrais desempenham um importante papel no contexto da Política Nacional de Medicamentos, que objetiva garantir a promoção do uso racional e o acesso da população a medicamentos essenciais. Tendo em vista a importância da abordagem da qualidade dos produtos manipulados, este artigo apresenta relevantes informações sobre o perfil de qualidade do serviço de saúde prestado por esse setor, mediante a revisão da legislação e de trabalhos científicos que englobam o assunto.
The magistral sector represents a significant segment in the Brazilian pharmaceutical market. However, the quality of magistral formulations is often questioned and the National Agency of Sanitary Vigilance (ANVISA) has demonstrated a concern regarding these products, which has been verified in many public consultations approaching this subject and in new legislation aiming to improve public health. Thus, magistral pharmacies play an important role in the context of the National Medicine Politics, which aim to assure promotion of rational use and population access to essential medicines. Due to the paramount importance of the magistral formulation quality, this article presents information about the basic importance and the quality profile of these products, through the revision of the legislation and of scientific works that approach the subject.
El sector magistral representa un importante segmento del mercado brasileño de medicinas. Sin embargo, la calidad de los productos ofrecidos por estos establecimientos es frecuentemente discutida y la Agencia Nacional de Vigilância Sanitária (ANVISA), ha demostrado preocupación con los productos magistrales, por la promoción de consultas públicas abordando el asunto y por el aumento del rigor en las legislaciones específicas. Siendo así, las farmacias magistrales desempeñan importante rol en el contexto de la política Nacional de Medicinas, que busca garantizar la promoción del uso racional y el acceso de la población a las medicinas esenciales. Considerando la importancia del abordaje sobre la calidad de los productos manipulados, este artículo presenta relevantes informaciones sobre el perfil de la calidad del servicio de la salud ofrecido por ese sector, a través de la revisión de la legislación y de trabajos científicos que engloban el asunto.