FDAer lists most common aseptic production slips.FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. investigators still find recurrent problems in aseptic processing of sterile pharmaceuticals, although there is a "downward slope" in noncompliance noncompliance
failure of the owner to follow instructions, particularly in administering medication as prescribed; a cause of a less than expected response to treatment.
noncompliance found during preapproval inspections.
Robert Coleman, national expert investigator with FDA's Office of Regulatory Affairs The Office of Regulatory Affairs (ORA) is the part of the United States FDA that enforces the laws that govern food, drugs, medical devices, and other products that FDA regulates. , listed the following aseptic processing deficiencies during his address to the joint Parenteral parenteral /pa·ren·ter·al/ (pah-ren´ter-al) not through the alimentary canal, but rather by injection through some other route, as subcutaneous, intramuscular, etc.
1. Drug Association (PDA (Personal Digital Assistant) A handheld computer for managing contacts, appointments and tasks. It typically includes a name and address database, calendar, to-do list and note taker, which are the functions in a personal information manager (see PIM). )/FDA conference in Bethesda, MD, Oct. 1:
1. Disposing of media fills that in some way did not meet the norm and not including them in evaluating a process. Sometimes the defects that led to the disposal might only be cosmetic, he said.
Asked whether strict acceptance/rejection criteria for media fills might provide a more accurate picture of the process, Coleman said that sometimes those discarded media fills might provide valuable information. Especially when results were borderline. The fills that were discarded might have provided the data needed to obtain conclusive results, he explained.
2. Over-sterilization of media. This could cause problems by diminishing the nutritive nutritive /nu·tri·tive/ (noo´tri-tiv) nutritional.
1. Of or relating to nutrition.
2. Nutritious; nourishing. value of the media, Coleman said.
3. Failure to invert media fill units and lack of a system to identify when units were filled during the process.
Such a system can help track failures and help determine what to investigate, he said. Some companies get the incubation temperatures wrong, he continued, while others try to evaluate media fills in opaque containers. Investigators also report lack of proper investigations into media fill failures.
Training, clear SOPs stressed
4. Training. Coleman said some drug firm employees lack necessary training in such aspects of their job as proper gowning and aseptic aseptic /asep·tic/ (-tik) free from infection or septic material.
Of, relating to, or characterized by asepsis. techniques. He criticized manufacturers for hiring people with no training to perform media fill evaluation, especially temporary employees with no relevant experience.
5. SOPs being unclear about definitions. For example, when an SOP refers to "turbidity turbidity /tur·bid·i·ty/ (ter-bid´i-te) cloudiness; disturbance of solids (sediment) in a solution, so that it is not clear.tur´bid
The cloudiness or lack of transparency of a solution. ," Coleman said, asking several different people will elicit an equal number of opinions on what the word actually means.
Coleman also objected to the use of "Post-it" notes on SOPs, short notes on how to perform a procedure attached to the original procedure with adhesive note paper. He recommended that if the official procedure does not work as written, change the procedure. Coleman called the "Post-it" notes "a Readers Digest version of the SOP."