Responsibility of Regulatory Affairs in Pharmaceutical Industry

Stability studies are playing main role in the pharmaceutical industry. Stability studies for pharmaceutical drug products are having all guidelines like ICH, USFDA, EMEA, WHO and etc. Hold time study data shall give the assurance the maximum allowable hold times for bulk and in-process drug products. Generally one lot can be used for validating hold times if any inconsistency results were observed then another two lots can be used for this study. Major hold study required stages are mixing, blending, lubrication, binder solution, coating solution, uncoated tablets, coated tablets, filled capsules, syrup solution, power for injection, liquid injection, bulk creams/ointments/gels. Hold study samples need to pack with the regular used poly ethylene bags, sterilized containers, HDPE or Glass containers. Hold samples need to store at GMP conditions i.e. where the lot or stage holds in the manufacturing area. All the regulatory agencies also may expect the hold time study at critical stages to understand the trend of degradation during holding at in-process stages.