Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Release authority for intermediates can be delegated to production except for intermediates that are sold, what about intermediates that are shipped within companies within the same corporation? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans If the laboratory is part of the quality unit, must the procedures, test methods, equipment, etc., be approved by the quality unit in addition to the person in the laboratory? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans In the non-delegateable activities, does that mean that I cannot have a quality control laboratory as an external supplier? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans If the raw material is commercially available, and if this raw material is the API only after purification, so we’re basically one step removed, does the raw material manufacturer fall under Q7A? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans If the Act does not make a distinction between API and dosage drug product and 21 CFR 211 is a regulation and ICH Q7A is a guidance document, then an FDA investigator may still choose to inspect an API manufacturer using specifically and only 21 CFR 211. 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Did the Expert Working Group discuss a definition of timely? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans If equipment is closed, do you usually need environmental controls? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans When and where do we start applying CGMPs? For example, we may use isopropanol to make the reaction of our API or to purify API. We do not manufacture isopropanol, so does the manufacturer of isopropanol have to follow all the CGMPs that apply to us? Does the manufacturer of any excipient have to follow the CGMPs as we do? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A apply to excipients manufacturer? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans How are the FDA investigators actually receiving your advice and what are we doing to provide specific training? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans I’ve got a question here about critical deviation and non-conformity or nonconformance and why were these not harmonized in the document? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans When can we expect the industrial guidelines that went into the development of Q7A to be integrated into the local regulatory agencies. For example, as part of the CFR requirements that would insure compliance. 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans The FDA version of ICH Q7A. Why did the FDA version format the section numbers or leave out the section numbers? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans If GMP does not start until the starting material is used in the manufacture of APIs, why then are starting material manufacturers inspected for GMPs? 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there any guidance requirements within Q7A for starting materials? 1.45K 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? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans As a clarification to this question, will the Indian and Chinese regulators be enforcing Q7A on their domestic manufacturers? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Since most APIs are manufactured outside the US (80 percent or so), and the FDA’s moving to the MRA for inspections, what training is being given to government inspectors outside the US, and what about FDA foreign inspection teams? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Just confirming, the definition of “should” could vary from country to country in the final version, for instance the US FDA versus the EU version. What would you recommend for companies that are international/global? Another person also wanted some practical, down-to-earth words around what “should” should mean. In other words, in here, the person asks, is “should” in ICH similar to “must”, is “should” in FDA similar to “good to do?” In other words, I think there’s a little confusion around “should”. 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the main differences between the FDA’s March 1998 API draft and Q7A? 1.66K viewsDrugsPharmaceutical « Previous 1 2 … 10 11 12 13 14 … 82 83 Next » Question and answer is powered by anspress.net
