Quality control strategy of traditional Chinese medicine based on pharmaceutical product lifecycle management / 中国中药杂志

Quality control is pivotal in the research and development of traditional Chinese medicine, whose connotation is not limi-ted to the qualitative or quantitative detection of an indicator component, but extends to the establishment of a whole process quality control system from the perspective of pharmaceutical product lifecycle management. This study discussed the quality control strategy of Chinese medicine based on the concept of pharmaceutical product lifecycle management, and proposed the following suggestions:(1) to focus on the "holistic view" and "phased" characteristics of quality control and strengthen the establishment of quality control strategy based on top-level design;(2) to strengthen the research on quality control of Chinese medicine based on quality risk management, focus on the correlations of quality control indicators with the safety and effectiveness of traditional Chinese medicine, and establish a quality evaluation system consistent with the characteristics of traditional Chinese medicine;(3) to consider the characteristics of different registration classifications in the establishment of quality control strategy;(4) to highlight the quality correlation research, strengthen the quality transfer research, ensure the quality traceability, and establish a sound quality management system;(5) to strengthen the quality research on marketed drugs to achieve dynamic quality improvement.

Application of Quality Risk Management in Cleanliness Verification for Nonsterile Raw Materials / 中国药师

Objective:To take quality risk management as the guiding ideology and use failure mode and effect analysis ( FMEA) to evaluat the key of the whole process of cleaning validation which aimed to reduce the risk. Methods: FMEA was applied in the cleanliness verification of APIs. According to the risk priority values, the risk points and risk control measures were determined for the key validation of cleanliness verification. Results:Through the control measures, the final risk score was obtained to assess the impacts on the final product quality and patient safety. Conclusion:Quality risk management is applied in the cleanliness verification of non-sterile APIs, which can effectively verify all aspects of the process, improve the pertinence and reduce the quality system risks in the actual production process with important guiding significance.

Application of Quality Risk Management in Drug Withdrawal Links of Hospital Pharmacy / 中国药房

OBJECTIVE:To control the drug quality risk in drug withdrawal links of hospital pharmacy,and provide reference for the application of quality risk management(QRM)in hospital pharmacy. METHODS:Drug QRM was developed in drug with-drawal links through risk identification,risk assessment,risk control,risk assessment and other steps. Using the incidence of risk factors and reusable rate of withdrawal drug as indexes,related data of before(Jul.-Dec. 2015)and after(Jan.-Jun. 2016)devel-oping QRM in our hospital were compared to evaluate the effect of drug QRM. RESULTS:Determining whether specific storage drugs kept the required storage conditions,whether the numbers of withdrawal drugs counted to minimal packaging and other 5 fac-tors were high-risk factors(the risk score of each factor>4 points);control measures were taken separately for high risk factors, then high-risk factors were reduced to acceptable levels(risk score<4 points). After developing QRM,the incidence of risk factors were reduced than before(reduce 1.35%-6.19%),reusable rate of withdrawal drug was increased(98.64% vs. 86.32%)(all P<0.05). CONCLUSIONS:Developing QRM in drug withdrawal links of hospital pharmacy can reduce the drug quality risk.

Qualification and Validation in EU-GMP / 中国药师

Objective:To study the content in the new version of EU-GMP ANNEX 15 (draft) to find the changes of the new and the old version and help the domestic pharmaceutical enterprises meet the requirements of the EU-GMP and complete verification and validation activities.Methods:The new version and the old version of EU-GMP ANNEX 15 were compared,and the changes in the new ANNEX 15 were analyzed in order to understand the changes deeply.Combined with the current implementation status of verification and validation activities in domestic pharmaceutical enterprises,some suggestions on qualification and validation work were provided for domestic pharmaceutical enterprises.Results and Conclusion:The new revision of EU-GMP ANNEX 15 (draft) emphasizes qualification and validation activities during the life cycle of products,and processes,and risk management methods should be used in qualification and validation activities.

Application of quality by design in granulation process for Ginkgo leaf tablet (Ⅲ)： process control strategy based on design space / 中国中药杂志

In this paper, under the guidance of quality by design (QbD) concept, the control strategy of the high shear wet granulation process of the ginkgo leaf tablet based on the design space was established to improve the process controllability and product quality consistency. The median granule size (D50) and bulk density (Da) of granules were identified as critical quality attributes (CQAs) and potential critical process parameters (pCPPs) were determined by the failure modes and effect analysis (FMEA). The Plackeet-Burmann experimental design was used to screen pCPPs and the results demonstrated that the binder amount, the wet massing time and the wet mixing impeller speed were critical process parameters (CPPs). The design space of the high shear wet granulation process was developed within pCPPs range based on the Box-Behnken design and quadratic polynomial regression models. ANOVA analysis showed that the P-values of model were less than 0.05 and the values of lack of fit test were more than 0.1, indicating that the relationship between CQAs and CPPs could be well described by the mathematical models. D₅₀ could be controlled within 170 to 500 μm, and the bulk density could be controlled within 0.30 to 0.44 g•cm⁻³ by using any CPPs combination within the scope of design space. Besides, granules produced by process parameters within the design space region could also meet the requirement of tensile strength of the ginkgo leaf tablet..

Application of Quality Risk Management in the GSP Implementation of TCM Trading Enterprises / 中国药房

OBJECTIVE:To provide reference for the implementation of quality risk management in GSP of TCM trading enter-prises. METHODS:The necessity of quality risk management in TCM trading enterprises was introduced;by using the method of quality risk management,based on hazard analysis and critical control point (HACCP) tool,according to the actual situation of TCM trading enterprises,four key links including the critical control points during purchasing,receiving and acceptance,storage and maintenance,exwarehouse and transportation were identified and controlled. RESULTS & CONCLUSIONS:It is recommend-ed that TCM trading enterprises take corrective measures aiming at the above four key links of risk control points like whether the procurement link was lawful and legal;how to control TCM acceptance quality;whether TCM maintenance method was valid;whether transportation and distribution affected the quality of goods. For this purpose,procurement link should be based on the es-tablishment of legal purchase channels;the experience of TCM appearance and property acceptance should be gathered in receiving and acceptance link to guarantee the quality of warehoused drugs based on the requirements of the newly revised GSP;storage and maintenance link should take an effective control of temperature and humidity,and carry out the scientific maintenance;exware-house and transportation link should highlight the“green logistics”,accomplishing quality and non-pollution.