Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Phase I clinical manufacturing. In a multi-step synthesis, after the quality unit releases our equipment before the start of the project, what is required/expected for equipment cleaning verification for the next step? Is the quality unit required to release the equipment or can the R&D team perform the project input and release the equipment? 1.81K viewsDrugsPharmaceutical 0 Votes 1 Ans Is Section 19 applicable for generic in process development phase for ANDAs? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Please elaborate on the need for equipment cleaning, verification versus cleaning validation for clinical trial products. 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans When commercial production in a pilot plant occurs, do you expect this to happen in dedicated equipment apart from equipment used for development? 1.61K viewsDrugsPharmaceutical 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? 1.59K 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? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Please discuss the expectations for records of deviation for clinical APIs. 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans Does ICH Q7 expect that the quality unit performs API release testing? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans What is meant by ‘quality unit(s) independent from production’? 1.50K 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)? 1.59K 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? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Did the FDA withdraw the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human Parenteral Drugs, Biological Products, and Medical Devices? 1.52K viewsFDA 0 Votes 1 Ans Can up to twelve month expiration-dating be assigned to oral solid and liquid dosage forms repackaged into unit-dose containers based on guidance in the May 2005 draft revision of Compliance Policy Guide, Section 480.200 (7132b.11), “Expiration Dating of Unit Dose Repackaged Drugs”? 1.55K viewsFDA 0 Votes 1 Ans Is an acceptability study required for each specific formulation? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Any specific packaging and labelling requirements? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there any FPP specification requirements for zinc sulfate formulations? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans How to conduct an Solubility testing? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Effects of excipients on zinc absorption? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a bioequivalence study report required? 1.63K 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? 1.58K viewsDrugsPharmaceutical « Previous 1 2 … 245 246 247 248 249 … 283 284 Next » Question and answer is powered by anspress.net
