BTEC 3321 Questions And Answers 2022

Subpart J The master production and control records can be signed electronically. 1. True 2. False - Answer - False Subpart J Where an investigation under 211.192 is not conducted, the written record shall include _____________ and the ____________. 1. the reason that an investigation was found not to be necessary, name of the responsible person making such a determination 2. the reason that an investigation was found not to be necessary, time and date of the occurrence. 3. an adequate action done in place of the investigation, name of the responsible person making such a determination. 4. an adequate action done in place of the investigation, time and date of the occurrence. - Answer - the reason that an investigation was found not to be necessary, name of the responsible person making such a determination J The batch production and control records shall include: 1. in-process and laboratory control results 2. All answers apply 3. identity of individual major equipment and lines used 4. statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing - Answer - All answers apply Subpart J Written record of each complaint needs to be maintained for at least: (Check all that apply) 1. two years after the expiration date of drug product 2. one year after the date that the complaint was received 3. one year after the expiration date of the drug product 4. seven years after the date that the complaint was received 5. three years after distribu