The Use of Digital Technologies for the Purpose of Improving Methodological Approaches to the Creation of a Pharmaceutical Quality System at Enterprises for the Production of Medicines

Introduction. The article is devoted to the aspects of improving methodological approaches to the creation of a pharmaceutical quality system (PQS) at enterprises for the production of medicines, taking into account the possibility of using tools and means of digitalization. The relevance of the study is associated with the enduring importance of comprehensive high quality assurance in the development, production and release of medicines into circulation. The implementation of PQS requires numerous transformations of management and production processes, which can be facilitated by tools and elements of digitalization.Aim. To consider the potential and specific areas of application of digital technologies to improve the methodology and practice of developing and implementing PQS.Materials and methods. The state in the subject area was assessed on the basis of the results of economic and statistical analysis and forecasting of the implementation of PQS at Russian pharmaceutical enterprises that have positive and comparatively long experience in this area: the companies LLC "OZON" and JSC "AKRIKHIN". The assessment was carried out by calculating the integral indicator of the effectiveness of the functioning of PQS, which is a set of weighted key performance indicators (KPI) for quality.Results and discussion. The importance of the introduction of PQS for the development of pharmaceutical enterprises and the presence of numerous difficulties in the implementation of PQS, which necessitates the improvement of methodological approaches in the subject area, are stated. It has been proven that even at those enterprises where PQS has been introduced with varying degrees of success, the use of digitalization tools would contribute to a faster, more systematic and high-quality implementation of PQS. Among the key areas of application of digital tools, the authors propose monitoring of quality indicators (using neural network cards) and the use of blockchain platforms and smart contracts to register the release of drugs of appropriate quality.Conclusion. Digital tools contribute to complex improvement in many areas of socio-economic activity. Their active use at pharmaceutical enterprises is intended to contribute to ensuring the proper implementation and uninterrupted functioning of pharmaceutical quality systems, through constant monitoring of the quality of manufactured products and registration of manufactured batches in high-precision information storage systems.

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

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.

Risk Management: How Not To Do It

Regulations worldwide tell us that a Pharmaceutical Quality System has to be risk-based. In reviewing best practices and ICH Q9 guidelines on QRM, the author shares insights on what not to do, using examples the author has come across over the more than 30 years in industry.

Pharmaceutical quality of antimalarial drugs: quinine sulfate and Artemether/Lumefantrine tablets sold on Bukavu Market

Background Generic antimalarial drugs sold in sub-Saharan Africa require tighter control as counterfeiting has grown more and more out of control. The study aimed to analyze the pharmaceutical quality of quinine sulfate (QS) and Artemether/Lumefantrine(AL) tablets marketed in Bukavu city compared to the current trends in other African cities. Results The samples were purchased in community pharmacies or from ambulatory street vendors and analyzed using a set of thirteen simple tests, including visual inspection, UV spectrometry, TLC, and conventional quality control procedures. More than 93% of AL samples had an acceptable global quality score of > 90%. Around 16.6% of QS batches did not satisfy the requirements about hardness, friability, and mass uniformity. Only 33.3% met the disintegration quality; 33.3% did not contain quinine; 8.33% had an active ingredient other than quinine. Conclusion The findings strongly alert the circulation of fake antimalarial medicines observed in many countries. Simple TLC procedures may help to detect any low-quality generics to avoid microbial resistance and guarantee the health of the population. Pharmacists and regulatory authorities are alerted to the circulation of low-quality generic quinine preparations in the country.