Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Please clarify the meaning of “training should be periodically assessed”. Does this mean competency assessment of those being trained, i.e. post-training assessment? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans What dosage forms for zinc sulfate are being sought for prequalification? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the minimum stability requirements for the API and FPP? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there any API specification requirements for zinc sulfate? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans In a multi-step API manufacturing process, can charging operations for earlier noncritical steps be done outdoors, as long as the last several critical steps are done indoors? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the expected frequency of testing of High Purity Water systems, such as Purified Water with Endotoxin Control: daily, weekly, bi-weekly, monthly, etc., for point of use sampling? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans For Intermediate processing, comment was made that the processing of potentially toxic, i.e. pesticides, was not that significant an issue. Can a company support such an activity? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Is Purified Water or Water for Injection the quality of water you are requiring or recommending for use in API production? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Permanently installed pipe work identification: would documentation be a P&ID, or would a process flow diagram be an adequate substitute for labeling individual lines? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Which engineering steps during the planning of a new API plant should be kept, documented, and verified? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the manufacture of API’s require the establishment of air quality standards, HVAC systems specifications to insure no dust migration during the charging of components used in API manufacturing from one reactor to another? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Would it be acceptable to use annual product review as an opportunity to determine which processes and products require revalidation? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Under Section 2.5, the product quality review, what is the expectation for the review of critical in process control and critical API test results? 1.79K viewsDrugsPharmaceutical 0 Votes 1 Ans Similarly, what is expected in the product quality review for the review of the accuracy of the corrective actions? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans In the past there has always been a difference between the qualified person as defined in Europe and his or her responsibility and the responsibilities deriving from the education of a person are being seen in the U.S. Can you comment whether this continues to exist and is being seen differently? Basically we’re looking at the European question of a qualified person versus here 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the Q7A Section 3 on personnel directly apply to laboratory and QA personnel, i.e., adequate number of qualifications, etc., or is it intended to apply only to the manufacturing personnel? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans What personnel are covered by the training requirement? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Please discuss ways in which investigators will assess whether there are an adequate number of personnel. 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Is training using the Internet acceptable? If so, how could it be documented? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Does training record maintenance differ significantly from what is specified by 211? 1.63K viewsDrugsPharmaceutical « Previous 1 2 … 8 9 10 11 12 … 82 83 Next » Question and answer is powered by anspress.net
