Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Does Section 19 mean, in the manufacturing for APIs for clinical trials, it is not required to conduct formal DQ, IQ, OQ, PQ for equipment? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you assure that the material that will ultimately be used in product for human use is safe considering many exemptions such as discussed about validation? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Please discuss the expectations for records of deviation for clinical APIs. 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Does ICH Q7 expect that the quality unit performs API release testing? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans What is meant by ‘quality unit(s) independent from production’? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Does ICH Q7 apply to manufacturing Steps for the addition of substance(s) to an API (e.g., to stabilise the API)? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Should GMP according to ICH Q7 be applied for manufacturing Steps before the defined ‘API starting material’ i.e., Steps not identified in grey in Table 1? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an acceptability study required for each specific formulation? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans Any specific packaging and labelling requirements? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there any FPP specification requirements for zinc sulfate formulations? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans How to conduct an Solubility testing? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Effects of excipients on zinc absorption? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a bioequivalence study report required? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Is evidence of Marketing Authorization required to demonstrate that the product is registered or approved for sale in accordance with national requirements? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans How much evidence is required as proof of validation of the manufacturing process of the FPP? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans At product changeover, are both visual examination and analytical testing necessary to verify that equipment is clean? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it expected that campaign manufacturing be addressed in cleaning validation? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it expected that equipment cleaning time limits be confirmed in cleaning validation? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Should acceptance criteria for residues be defined for dedicated equipment? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans For dedicated equipment, is ‘visually clean’ acceptable for verification of cleaning effectiveness, (i.e., no expectation for specific analytical determination)? 1.52K viewsDrugsPharmaceutical « Previous 1 2 … 64 65 66 67 68 … 82 83 Next » Question and answer is powered by anspress.net
