RT Journal Article
SR Electronic
T1 The Advisory Role of FDA District Offices in the Planning of a New Parenteral Facility
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 94
OP 97
VO 38
IS 3
A1 Tetzlaff, Ronald F.
YR 1984
UL http://journal.pda.org/content/38/3/94.abstract
AB It has become a common practice for parenteral drug manufacturers to seek FDA advice/recommendations when constructing new facilities or for major plant modifications. The benefits of such contacts can be optimized if proper procedures and protocols are followed. The decision of whether to contact headquarters or local FDA field offices should be based upon the type of information desired. Policy matters may be directed to the headquarters units whereas specific matters pertaining to local facilities should be directed to the FDA field offices. Firms should be realistic in the type of information expected during such reviews. Generally, initial review of design and blueprints will necessarily be general in nature to identify major problem areas. Firms should not expect that FDA will approve design features. It is important that personnel representing the company should be familiar on a day to day basis with the systems being reviewed. The specific documents should be general enough to permit basic understanding of the systems, but sufficient supporting documentation should be available to answer any pertinent or detailed questions or concerns.