Quality problem of drug products produced in hospitals in Thailand.

Problems of drug quality prepared in hospitals in Thailand were collected during January 1990-December 1998. From laboratory findings, evidence of instability in 649 samples were evaluated. Problems were found in various types of pharmaceutical dosage forms (oral liquid preparation 43.8%, parenteral products 21.6%, topical preparation 20.6%) and water samples for pharmaceutical purposes 14.0%. The types of instability were: chemical change 44.8%, microbiological change 25.3%, physical change 17.5% ( appearances 3.8 per cent and properties 13.7 per cent) and a combination of changes 12.4%. In addition, expiration dates were not stated on the labels (94.3 per cent) since these products may be dispensed a short time after preparations, instability was found between 1 month and over 12 months after manufacturing with the highest frequency of occurrence filling within 2-3 months. For the products with a stated shelf-life of 6 months, 1 or 2 years, stability problems of 37 samples occurred between 1 month to 6 months after manufacturing, with maximum occurance at 1 month. Type of containers used were problematic. It was found that 64.5 per cent of problems occurred in transparent glass bottles and 36.7 per cent in semi-transparent plastic bottle packages. To avoid quality problems, the authors suggest that hospitals must be developed and use high-quality active ingredients, water, production process and areas which comply with current Good Manufacturing Practices requirement.