Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans If equipment is closed, do you usually need environmental controls? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A apply to excipients manufacturer? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans If an employer fails to tell an employee that leave has been designated as FMLA leave, can the employer count the leave against the employee’s FMLA leave entitlement? 1.64K viewsHuman Resources 0 Votes 1 Ans Which employers are required to provide FLA leave? 1.49K viewsHuman Resources 0 Votes 1 Ans How long must an employee work for an employer to qualify for FLA leave? 1.69K viewsHuman Resources 0 Votes 1 Ans What leave benefits are covered by the FLA? 1.35K viewsHuman Resources 0 Votes 1 Ans How does the state FLA, the federal FMLA, and the leave benefits for pregnancy disability interact? 1.65K viewsHuman Resources 0 Votes 1 Ans Based on FDA changing of the meaning of “should”, does this mean that Q7A will be applied differently in the US than in the EU? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you define a “significant structural element” in an API starting material? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans How close can you get to the API and still call it an API starting material? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans How early should a company discuss with FDA the company strategy, rationale and what we consider to be an API starting material for filing? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans If you identify an API starting material vendor, does that vendor need to be audited or qualified? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans Are internal audit reports mentioned in Section 2.4 subject to FDA review during an inspection? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Concerning the distinction that you made between ICH versus VICH for APIs for veterinary products, which standards do the FDA inspectors use in the plants producing APIs for US vet products? Are there any differences seen during a PAI, and which standards should a plant follow? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans You said that the WHO has now decided to compare the Q7A document with its 1992 API GMPs., I heard previously that the WHO was adopting Q7A with no mention of this evaluation. Is this just a standard procedural issue at WHO or do they have specific concerns, doubts, problems with Q7A? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans To my knowledge, China, Australia, and India have not had official (observer or participant) status in previous ICH guidance processes. By participating in Q7A, do they agree to be bound by it? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Have U.S. manufacturers of potassium iodide been asked to ship any products to Japan? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a sponsor of an investigational new drug export its product to Japan? Does FDA have to authorize such an export? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans How can consumers identify products that may be violative? 1.52K viewsFDA 0 Votes 1 Ans Do the GLPs apply to all of the analytical support work conducted to provide supplementary data to a safety study? 1.56K viewsDrugsPharmaceutical « Previous 1 2 … 274 275 276 277 278 … 283 284 Next » Question and answer is powered by anspress.net
