How can manufacturers assess and address the risk of microbiological contamination of topical antiseptics?. 
What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products?.Why is FDA concerned about human topical antiseptic drug products?.Is the same frequency expected of a process conducted in an isolator? What is the acceptable media fill frequency in relation to the number of shifts? Normally, media fills should be repeated twice per shift per line per year.How do I contact CBER with questions about PAT?.How do I contact CDER with questions about PAT?.How can I implement PAT (process analytical technology)? In 2004, FDA issued a guidance entitled PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance that encouraged industry to modernize manufacturing through enhancements in process control.
#PDA NET ANY GOOD? ISO#
Is it generally acceptable from a CGMP perspective for a manufacturer of sterile drug products produced by aseptic processing to rely solely on ISO 14644-1 and ISO 14644-2 when qualifying its facility?. Do CGMPs require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished drug product is released for distribution?. Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than for other products and processes. Investigation did not show any obvious causes. What could be the source of contamination? They conducted their media fills using TSB (tryptic soy broth) prepared by filtration through a 0.2 micron sterilizing filter. 
A firm has multiple media fill failures. Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse?. Do the CGMPs require a firm to retain the equipment status identification labels with the batch record or other file? Assuming each major piece of equipment has a unique cleaning and use log that is adequately retained, is it acceptable to discard these quick reference equipment labels?.
0 kommentar(er)
