Process Validation of an Anticancer Drug

ISBN-13: 9786204979465 / Angielski / Miękka / 124 str.

Anjali Sharma; Devkant Sharma

Opis

The process validation of dosage form is one of the most important regulatory requirements for pharmaceutical industry. It shows the documented evidence about the quality of the product by validating the whole manufacturing process. According to USFDA, process validation is the collection and evaluation of data, from the design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality attributes. The aim of current study was to prospectively validate the manufacturing process of tablets of drug X and assure that product meets predetermined specifications and quality attributes as per FDA and cGMP requirements. To achieve the said goal, a robust validation protocol was designed wherein critical process parameters were identified. Certain routine in-process evaluation tests and challenge studies were performed. Also tests on finished product were executed.

O autorze

Anjali Sharma is presently working as Assistant Professor at Guru Gobind Singh College of Pharmacy. Her field of specialization is Pharmaceutics. She has 7 plus years of teaching experience.Devkant Sharma is presently working as Associate Professor at CH. Devi Lal College of Pharmacy, Yamunanagar. His field of specialization is Pharmaceutis.