Pharmaceutical Quality Assurance Microbiology Laboratories

2006 ◽  
pp. 2783-2793
Keyword(s):  
Quality Assurance ◽  
Pharmaceutical Quality

scholarly journals Integrity performance assessment of a Closed System Transfer Device syringe adaptor as a terminal closure for Luer-Lock syringes.

2021 ◽  
Author(s):  
Alan S Wilkinson ◽  
Kate E Walker ◽  
Romana Machnikova ◽  
Laima Ozolina ◽  
Andrew J Johnson ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Closed System ◽  
Contact Time ◽  
Closure Device ◽  
Pharmaceutical Quality ◽  
Chemotherapy Drugs ◽  
Integrity Testing ◽  
Container Closure ◽  
The Uk ◽  
Transfer Device

Objectives To investigate the container closure integrity of a Closed System Transfer Device syringe adaptor lock in combination with disposable Luer-Lock syringes as the terminal closure device. The UK NHS Pharmaceutical Quality Assurance committee requires syringe integrity data for final storage devices of aseptic products such as chemotherapy drugs when prepared in advance and stored prior to use as is standard practice for dose banded drugs. The assessment comprised both physical and microbial integrity testing of the combination closed system/ Luer-Lock syringes containers at syringe sizes: 1mL, 20mL, and 50mL. Methods Integrity testing was performed as described in the NHS Pharmaceutical Quality Assurance Committee Yellow Cover Document 2nd edition 2013 with ChemfortTM (Simplivia, IL) syringe adaptor lock devices as replacement for sterile blind hubs. Microbiological integrity was assessed according to Method 1 part 1.4 using Brevundimonas diminuta at 32oC for up to 14-days contact time. Physical integrity was assessed using Method 3 of the yellow cover document which is a dye intrusion method. Dye intrusion was assessed both visually and using a validated ultraviolet-visible spectrophotometer method. Results ChemfortTM syringe adaptor lock/ Luer-Lock syringe combinations were shown to be: (1) free of microbiological contamination after 14-days contact time, (2) free of dye intrusion at all syringe sizes tested (n=61 in total). The data demonstrates 100% closure integrity of the final container system when ChemfortTM syringe adaptor lock replaces the syringe hub as the terminal closure device. Conclusions Syringe adaptor lock components complied with the NHS Pharmaceutical Quality Assurance Committee Yellow Cover Document syringe integrity requirements when used as the terminal closure of Luer-Lock disposable syringes from 1mL up to 50mL. Therefore, syringe adaptor lock (ChemfortTM) can be used as the terminal closure system for pre-filled syringes of chemotherapeutic drug products prepared in advance in UK NHS Pharmaceutical Technical Services.

scholarly journals PHARMACEUTICAL QUALITY AUDITS: A REVIEW

2019 ◽  
Vol 11 (1) ◽  
pp. 14
Author(s):  
Princy Agarwal ◽  
Amul Mishra
Keyword(s):  
Quality Assurance ◽  
Pharmaceutical Industry ◽  
Pharmaceutical Company ◽  
Search Engine ◽  
Quality System ◽  
Vital Function ◽  
Regulatory Requirements ◽  
Reimbursement Mechanisms ◽  
Quality Audit ◽  
Pharmaceutical Quality

Auditing is a vital function within a pharmaceutical company nowadays. Quality audit is a review and evaluation of all or part of a quality system with the specific purpose of improving it. It is one of the means to examine pharmacy programs and ensures that the procedures and reimbursement mechanisms comply with the contractual and regulatory requirements. A quality audit is usually conducted by external or independent experts or by a team designated by management for this purpose. These audits can be extended to suppliers and contractors as well. An audit will assess the strengths and weaknesses of quality assurance and quality assurance processes, the results of which assists in improving processes and building a better system for company benefits. This article focuses on various aspects of quality auditing in the pharmaceutical industry including its principles, objectives, importance and benefits and planning along with the deficiencies that are likely to occur during the process. This review comprises a well-organized summary of various guidelines available till date using the Google Scholar search engine and the keywords listed below.

scholarly journals Guidelines for Promoting the Implementation of Pharmaceutical Quality Systems at EAEU Enterprises Through the Management of the Engagement of Production Personnel

2021 ◽  
Vol 10 (1) ◽  
pp. 136-141
Author(s):  
V. A. Smirnov ◽  
V. V. Goryachkin ◽  
V. N. Shestakov ◽  
R. A. Abramovich
Keyword(s):  
Quality Assurance ◽  
Labour Productivity ◽  
Good Manufacturing Practice ◽  
Economic Indicators ◽  
Steady Increase ◽  
Quality Systems ◽  
Pharmaceutical Quality ◽  
The Impact ◽  
Pharmaceutical Enterprises

Introduction. The publication is devoted to the topical organizational and personnel issues of the implementation of the pharmaceutical quality system (PQS). The relevance of the study is due to the high importance of quality assurance in the development, production and release of drugs into circulation.Aim. The aim: to develop guidelines for organizational and personnel assistance in the implementation of pharmaceutical quality systems at enterprises of the Eurasian Union (EAEU) for the production of medicines (drugs) through the toolkit for engaging production personnel in the development of PQS.Materials and methods. Personnel engagement was assessed based on the engagement index; the benchmarking method was used when studying the impact of the engagement of production personnel on the economic indicators of corporate development (indicators of engagement and related economic indicators of “Akrikhin”, “Ozon” were compared with a panel of similar indicators for 12 pharmaceutical enterprises of the EAEU).Results and discussion. The important role of ensuring an increase in the engagement of production personnel in the development of PQS as a tool for sustainable provision of the effectiveness of the implementation of PQS and standards of good manufacturing practice (GMP) at drug production enterprises is stated. Taking into account the experience of forming quality circles in classical Japanese management, an innovative toolkit for managing the engagement of production personnel is proposed, based on the formation of employee communities, coordination and management of their engagement and development through the corporate portal of a pharmaceutical enterprise, as well as membership in closed clubs of ‘quality leaders’.Conclusion. Management of communities (small groups) of production workers is considered as a tool for improving the organizational and personnel support for the implementation and improvement of PQS / GMP at the EAEU pharmaceutical manufacturers. Through the communities, it is proposed to simultaneously manage the engagement, loyalty and job satisfaction of production personnel; community members, through the exchange of best manufacturing practices, ideas and opinions on the development of PQS and the improvement of nuclear quality assurance practices, will stimulate themselves and other production workers to consistently ensure the quality of manufactured drugs. The expected result is a steady increase in the quality of manufactured drugs, adherence of production personnel to the quality philosophy, creation of conditions for the growth of labour productivity of production personnel of pharmaceutical enterprises.

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