Docket Management
Docket: 00D-1418 - Q7a ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Comment Number: EC -8

Accepted - Volume 1

Comment Record
Commentor Ms. Barbara Zinck Date/Time 2000-09-25 14:30:45
Organization Bio Science Contract Production Corp.
Category API Manufacturers

Recommended Changes / Reasons
Lines: 79-79
Section: 1.3
According to the Table, GMPs do not apply to cell banks. Thus a Working Cell Bank could be manufactured prior to release of the Master Cell Bank.
Recommended Change Type: General Comments
Lines: 111-115
Section: 2.1
Use of raw materials pending completion of evaluation contradicts 21 CFR 211.84(a).
Recommended Change Type: General Comments
Lines: 1599-1681
Section: 19
APIs for Use in Clinical Trials should delineate tighter cGMP controls such as validated facilities, validated equipment, qualified cleaning procedures, and qualified analytical methods.
Recommended Change Type: General Comments Since there is limited knowledge of APIs used in early stage clinical trials, it is critical to at least have fully validated facilities and equipment to ensure safety, quality and homogeneity of the API.

EC -8