Expertise I can answer about all validation and qualification activities like Equipment qualification, analytical method validation, process validation, calibration and verification, Machine capability study, stability studies, cGMP, GVP, GDP, QMS, TQM, ISO and Regulatory affairs.
Q: I would be extremly greatful if you could answere the following“Explain why calibration is a GMP ... A: The intent of the GMP calibration requirements is to assure adequate and continuous performance of ...
Q: I would be grateful if you could answer the followingDefine the term 'validation of a cleanroom' ... A: The basic Defination of Validation is the same as mentioned in WHO TRS 937 and FDA, whether its a ...
Q: Que-- If due to any reason there is delay in sample charging in stability chamber more than 15 days ... A: In the stability protocol you will mention the date of commencement when you will keep the samples ...
Q: We are manufacturing Oral dosage form & our product is approved under ANDA by FDA Condition 1) We ... A: Answer 1)No!! You dont need to perform inprocess test (DT/Hardness/Thickness)on pooled sample QC ...
