1. New development plan available 2. Job responsibilities for newly joined employees are available 3. Are the scale-up and commercial batch production stages and data reviewed to demonstrate adequacy of scale-up process? 4. Do the scale-up show consistency among batches? 5. Are the in-process and finished ...

1 Departmental Organogram 2 Job responsibilities for newly joined employees are available 3 Toilet facilities available i) Adequate ii) Clean iii) Well ventilated iv) Segregated from working area 4 Prohibited in working area i) Smoking ii) Chewing tobacco iii) Eating /Drinking 5 Health checks for ...

1 Departmental Organogram 2 Job responsibilities for newly joined employees are available 3 Persons engaged in analytical activity i) Clean uniform ii) Sterile garments for microbiology 4 SOP on cleaning i) Glass apparatus ii) General cleaning of department iii) Specific area 5 Toilet facilities available i) Adequate ii) Clean iii) Well ...