We wish to delete a number of manufacturing sites at the same time as these are no longer used. Can we submit one change 9 variation to cover all these changes?
• We wish to register a new site of active ingredient manufacture by Type IA change 15 notification, as the manufacturer holds a Ph Eur Certificate of Suitability (CEP). The CEP does not state a retest period but we have stability data to support this. Can we tick condition 3 and include the stability with the Type IA #15 notification? • We wish to add a new site of manufacture of active substance or starting material by submitting a Type IA notification (change 14 or 15). What information should be included in the QP declaration in respect of the GMP status of the active substance manufacturer confirming compliance with Article 46(f) of Directive 2004/27/EC? • For changes to manufacturing batch sizes (change 32) one of the conditions is that the pharmaceutical form is a standard/immediate release oral form or non-sterile liquid form. What is the situation for increasing the batch size of ointments, suppositories or other pharmaceutical forms? • We wish to delete one of the pack sizes
Related Questions
- We wish to delete a number of manufacturing sites at the same time as these are no longer used. Can we submit one change 9 variation to cover all these changes?
- I currently have 4 VoxTransit lines, but only two are being used. Could you delete the lines that are no longer in use?
- Im trying to delete one of my favorites. How do I remove a favorite I no longer wish to have?
