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What is Media Fill The Media fill or Broth fill technique is one in which a liquid microbiological nutrient growth medium is prepared and filled in a simulation of normal manufacturing operation. The microbiological growth medium such as Soybean Casein Digest Medium (SCDM) is processed and handled in a manner which simulates “normal” manufacturing process … Continue reading Media Fill Process →

General Pattern: Locate the problem by ranking possible causes.Verify the presence of the most probable cause.If present – fix the problem, otherwise verify the existence of the next possible cause. First try to distinguish System problem or Method Problem HPLC System Components Pump Injector/ Autosampler Column Detector Data System/Integrator Method vs. System Troubleshooting System Parameters … Continue reading HPLC Troubleshooting →

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 →

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) →