1.A review article on cleaning validation in pharmaceutical industry
Mongolian Pharmacy and Pharmacology 2022;21(2):27-34
Abstract
In pharmaceutical industry there are some possibilities of contamination and cross contamination because of improper cleaning of equipment, apparatus, processing area or the starting material, this can lead to severe hazards, therefore in pharmaceutical industry we could not afford any contamination as well as cross contamination. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. Prevention of cross contamination is one of the most significant conditions of Good Manufacturing Practices for drugs. This is especially topical for a multipurpose (shared) manufacture where several medicinal products, including drugs of different pharmacotherapeutic groups, are produced using the same facilities (manufacturing areas, workrooms, and equipment). The industry is able to achieve these key goals with the help of implementation of GMP. Therefore, a perfect cleaning method is required for avoiding the possibilities of contamination and cross contamination, for this a validated program is required, this program is known as cleaning validation. “Cleaning validation is documented evidence which assure that cleaning of equipment, piece of equipment or system will obtain pre-determined and acceptable limits”.
2.Assessing neuro-psychological status of drivers involved in the traffic accidents
Ulziibayar D ; Mandakh T ; Bujin TS ; Gantsetseg T ; Nomindalai B
Mongolian Medical Sciences 2013;163(1):158-163
Psycho-neurological syndrome which is driver’s health status plays a crucial role in ensuring road traffic safety.GoalThe study aims to determine factors leading to traffic accidents by assessing psycho-neurological status of drivers who caused road traffic accidents.MethodsIt is a double-randomized and cross-sectional study. Drivers caused the traffic accidents in the territory of Bayanzurkh District of Ulaanbaatar city between September 2011 and May 2012 were involved.Following investigations were done:• Thorough neurological examination using a prepared clinical pathway;• EEG test;• Assessment of attention, memory, intellectual speed and anxiety of drivers using Lusher test and computer based test.SPSS 18 was applied in data analysis and chi square test was applied in differentiation the proportions.ResultsThe male-female ratio among 394 drivers was 61.9% and 38.1% respectively. 322 drivers (89.04%) had symptoms of episodic headache, dizziness, blurred vision and unsteadiness. 60 drivers (15.2%) had nystagmus which is the main symptom of vertigo (p<0.001). 159 (40.9%) drivers experienced an insomnia. Epileptic and nonepileptic seizure was observed in 155 cases. Out of 394 drivers 243 (61.6%) had symptoms of anxiety. It was observed that 64.6% had low level of anxiety, 27.9% had medium, 7% had high level and 0.4% had severe anxiety. According to the Shultz table, we found that 46.4% of drivers were disintegrated attention and 12.4% (49) were with slow intellectual speed. The hypomnesia was 27.4% (108).Conclusions:1. According to our study, anxiety is dominated among the drivers and attention is disintegrated and slow.2. EEG results (abnormal II and III) proved that drivers who have epileptic and nonepileptic seizures are involved in the traffic accidents.3. Recurrent neurological conditions like headache, dizziness, insomnia, blurred vision and unsteadiness are preconditions for attention dispel, slowing of attention distribution and anxiety of drivers who caused traffic accidents and those recurrent neurological conditions are prevalent among drivers.