WL Samchundang Pharm Co., Ltd. MAY 13, 2020
1. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).
Your firm manufactures and aseptically fills (b)(4) drug products for distribution to the U.S. You did not establish the suitability of the sterility test method used for final release testing of (b)(4) of your finished drug products. In addition, you did not determine the suitability of the in-process bioburden test performed for each of your drug products.
Suitability testing must be performed for each drug product to ensure the sterility test method is valid. Suitability testing establishes that contamination, if present, will be detected. When inhibition is encountered during suitability testing, test method modifications allow for optimized recovery...
2. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
You did not routinely identify isolates recovered during environmental monitoring of your aseptic processing areas where your sterile drug products are filled. Per your procedure, SOP for Microbial Identification Management (QS-508), recovered isolates are grouped according to visual morphology. From the grouping of isolates with similar morphology, only one isolate is routinely identified for species determination.
You did not routinely identify isolates recovered during environmental monitoring of your aseptic processing areas where your sterile drug products are filled. Per your procedure, SOP for Microbial Identification Management (QS-508), recovered isolates are grouped according to visual morphology. From the grouping of isolates with similar morphology, only one isolate is routinely identified for species determination.
In addition, your personnel monitoring program specifies alert and action limits of three CFU/plate and four CFU/plate, respectively, for personnel working in the aseptic processing operation, including (b)(4) samples. Manufacturing personnel who perform operations in aseptic processing spaces should normally maintain contamination-free (b)(4) throughout operations. It is important to set action limits accordingly.
Inadequate environmental and personnel monitoring practices may obscure the type and level of microbiological contamination in your aseptic processing facility. Vigilant environmental and personnel monitoring provides ongoing information on the state of control of your facility. Growth observed on (b)(4) samples taken from personnel who can perform any activities within the ISO 5 areas should trigger an appropriate investigation...
