QUALITY CONTROL PARAMETERS OF PARENTERAL PHARMACEUTICALS BASED ON PHARMACOPOEIAS

Quality control is an essential operation of pharmaceutical industries. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Currently, world-wide efforts have been made to ensure the practice of quality along with coast effective good quality medicines. Parenterals are the sterile preparation that is directly administered into the circulatory system avoiding the enteral route. These preparations provide rapid onset of action compared to others, but the most concerning topics related to this, is their stability problem that arises from microbial contamination of the products. Therefore, to ensure their sterility and stability, regulations regarding to quality control through pharmacopeial specifications has a great importance. Pharmacopeias provides an effective guideline to overcome those problems by following current good manufacturing practices and establishing standard operating procedures. In-process quality control tests are done with a motive to remove error from every stage in production and maintain the quality of the final product with the compendial standards as specified in the pharmacopoeias. The quality of final products depends on in-process control tests, because it helps to incorporate excellence within the products. The qualitative and quantitative parameters of pharmaceutical products are checked by finished product quality controls tests. Therefore, the drive of this study is to provide concise information on the in-process and finished product quality control tests for parenteral preparations as per different pharmacopoeias. Keywords: Parenteral pharmaceuticals, Pharmacopoeia, Specification, In-process quality control, Finished product quality control.