Evaluating and Understanding the Reason for an Increase in Nonconformances in the Laboratory

This is a study of nonconformances experienced by a laboratory of a pharmaceutical manufacturing facility in East Africa. There has been an increase in nonconformances from 216 nonconformances in 2017 to 229 in 2018 and by September 2019, 306 nonconformances were already logged. Increasing nonconformances result in delayed release of tested materials and many resources are wasted (e.g. chemicals, man hours and equipment). Analysts become frustrated, which may result in inexhaustive investigations. Understanding the reason for the increase in nonconformances will enable the facility to derive effective solutions to the identified causes, hence reducing the number of nonconformances and improving the productivity and morale of employees. This quantitative, nonexperimental, longitudinal survey study was intended to evaluate and understand the reason for increasing nonconformances. Trends of the nonconformances, previous investigations, procedure for investigation and the training given to analysts have been reviewed. Laboratory incidences were the most recurring nonconformances; and these were mainly caused by analyst errors. Corrective and Preventive Actions (CAPAs) were derived by cross functional teams whenever root causes were identified. Procedure for investigation of nonconformances refers to investigative tools. Identification of root causes to nonconformances recently became mandatory. Analysts have limited advanced industrial training on investigation of nonconformances. Another study should be carried out to understand the cause of analyst errors. The study can be rolled out to other departments at the manufacturing facility to create similar improvements. Analysts should enroll into advanced courses of industrial pharmacy to gain advanced industrial skills which they can apply in investigations to find root causes to nonconformances.

A Review on Regulatory Authorities & Standards Institutions and Self Auditing Consideration in Pharmaceutical Industry

In the pharmaceutical industry the course is designed to give you the skills that have taken many experienced auditors decades to develop. It follows the auditing guidance of ISO-19011 and is a virtual audit of a manufacturing facility that makes a range of dosage forms. This allows you to plan and prepare audits of the supplier and your own supplier audit system. Throughout the course, there is personal practice with exercises and teamwork’s in planning, preparation and performance that address WHO. The extensive of course notes and excellent lectures given by knowledgeable and professional tutors in pharmaceutical industry, The WHO was very easy to approach with any problems in during the course. The purpose of regulatory authorities to assess application for authorization to market products for human use and either grant authorizations to market each product or reject such applications and inspect the manufacturers and wholesalers of medicines for human use and either grant manufacturing and wholesale licenses or refuse such licenses. The international regulatory authorities under consideration are in this article WHO, USFDA, MHRA, and Australian TGA. The standard institutions give the economical background for development and transferring technologies, ISI, ISO, BISS and ASTM. Keywords: Regulatory authority, WHO, Self-auditing, Standard institution

Occupational Health Risks from Combined Exposure to Welding Fumes and Cold Environment for Welders

Introduction: Intensification of economic activities in the northern regions of Russia requires a better understanding of the combined health effect of cold environment and occupational risk factors. Objective: To assess the risk of developing health disorders in gas and electric welders exposed to low and normal workplace temperatures. Materials and methods: We conducted a comparative analysis of working conditions and health status of welders at two enterprises. The main cohort included 310 workers exposed to welding fumes and cold microclimate in an underground mine. The control cohort included 282 employees of a railcar manufacturing facility performing their functional duties in workshops with acceptable microclimate parameters. Results: According to the results of periodic medical examinations, 499 chronic diseases were diagnosed in welders of the main cohort against 230 among the controls. Compared to the reference cohort, underground welders were at higher risk of developing diseases of the digestive system (RR = 2.63; CI: 1.47–4.70; p = 0.0006), genitourinary (RR = 6.55; CI: 1.51–28.4; p = 0.004), musculoskeletal (RR = 1.50; CI: 1.14–1.97; p = 0.003), and nervous systems (RR = 5.29; CI 1.19–23.4; p = 0.014), skin (RR = 3.85; CI: 1.61–9.18; p = 0.001), respiratory organs (RR = 3.23; CI: 1.84–5.69; p < 0.001), as well as infectious and parasitic diseases (RR = 8.61; CI: 2.03–36.5; p = 0.0004). Thus, the number of healthy workers was smaller while the number of workers suffering from two or more chronic diseases was bigger in this cohort (p < 0.001). Conclusions: The welders working in cold environment were significantly less healthy than those working in normal workplace temperatures. The results necessitate the development of additional measures of disease prevention for this category of employees.