Month: February 2022

User Requirement specification (URS) of Equipment’s in Pharmaceutical


User requirement specification (URS) is a list of all the requirements from the user, like equipment to be purchased. After the preparation of the list, the documents are sent to the manufacturer to get the required materials as per the given criteria. The user department will raise the indent for his requirement regarding machine equipment or … Continue reading User Requirement specification (URS) of Equipment’s in Pharmaceutical

Requirements for Good Documentation Practices (GDP)


Introduction :This chapter defines the requirements for good documentation practices which build a basic foundation for a good quality management system. Good documentation practices are those measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original, and accurate.Good documentation practices follow to protect the integrity … Continue reading Requirements for Good Documentation Practices (GDP)