Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Where do gases fall, i.e., nitrogen for the blanket, as a raw material or process aid? Do they require material management control, quarantine, ID testing, etc? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Under Section 7.3, third paragraph, “describe other special materials.” These are materials excluded from testing. Does the company define the special materials? If so, on what basis? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an appropriate system to allow a material’s use while still under quarantine? What makes a conditional release appropriate? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans As a repackager of APIs, we use an expiry date only when one is given by the manufacturer. However, in a recent inspection, the investigator insisted that all APIs should have an expiry date. We believe this to be incorrect and would like to know what argument we should use to defend the fact that most APIs do not have an expiry date. 1.73K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it expected to have a complete graph or printout of the whole process batch attached to the batch record for a critical or significant step? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Since results for critical process parameters must be recorded, must the API manufacturer identify critical process steps and parameters in the batch production record? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Must the intermediate and API storage containers be identified in the batch production records? Must critical materials be identified in the batch production record? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Corrections have to be signed and dated. How about the original entry? Seems logical that both be dated. 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Q7A definition for deviations? For example, if one forgets to sign and date a step, but the same person goes back at a later time and signs and dates the step, does a deviation need to be written? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Does 9.4 label information apply to API samples submitted for laboratory testing? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to delegate the batch record review of non-critical process steps to production, reviewing completed batch records and lab records of critical process steps before the release of the API? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Should the time of execution of each step in the batch record be recorded? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Is black ink pen, which looks like photocopying, acceptable for filling in data in batch records? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Equipment cleaning and use records. For multi-use, non-dedicated equipment, is it acceptable to have these records as part of the batch record or is a separately maintained record required. 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans For an existing registered process, is the starting material listed in the drug master file registration the starting material for Q7A? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the section on equipment cleaning and use records (section 6.2) apply to lab equipment in the laboratory. For example, HPLCs, balances, GCs, etc.? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Control data requests that you retain data on the preparation and testing of reference standards. Since many of the reference standards are purchased, how can one accomplish this? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans In deciding if a deviation is critical, would one normally expect to see what requirements are critical versus non-critical pre-defined in the production instructions? If not, what justification would one expect to see? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a distinction between a significant and a critical step? Q7A does not define “significant”. 1.65K viewsFDA 0 Votes 1 Ans If a data entry were missed, not done directly after performing the activity, is noted and corrected subsequently, i.e. the next day, would you expect a deviation report, in addition? 1.52K viewsDrugsPharmaceutical « Previous 1 2 … 262 263 264 265 266 … 283 284 Next » Question and answer is powered by anspress.net
