Standard Operating Procedure Manual. Calibration of glassware & equipment’s for quality control

      Аннотация: Being the teachers of Pharmaceutical Analysis and Quality Assurance for more than six year and 4 years at Teerthanker Mahaveer College of Pharmacy, Teerthanker Mahaveer University, Moradabad, India. We have developed passion for learning & writing more about the Regulations, like ICH, cGMP, ISO, USFDA, & other regulation. This creation of a book will help the pharmaceutical professionals in nourishing the knowledge of calibration of different equipment’s for developing a pharmaceutical industry quality control laboratory with optimized standards as well as in contract testing laboratory/institute. Keeping in view the calibration requirements for specific and highly accurate with precise analytical methods have been evolved with the passage of time which have now occupied pivotal and vital positions in most of the Official Compendia viz., USP, BP, Int.P., Eur. P, IP etc. The developments in the fields of pharmaceutical science and technology being utilized as on date, amalgamated with relatively stringent new regulations, namely: Federal Drug Authority (FDA); International Conference on Harmonization (ICH); Current Good Manufacturing Practices (cGMP); Pre-Approval Inspections.

Ключевые слова: Calibration, FTIR, HPLC, Instrument, sop, UV, Glassware