Biomedical Engineering Reference
In-Depth Information
Table 7.1
(
Continued
)
Regulation
Topic
§211.160(a)
Laboratory controls
§211.165(c)
Testing and release for distribution
§211.166(a)
Stability testing
§211.167
Special testing requirements
§211.176
Penicillin contamination
§211.180(f)
Records and reports
§211.198(a)
Complaint fi les
§211.204
Returned drug products
Approach to Pharmaceutical cGMP Regulations
indicates
that “training should address the policies, processes,
procedures, and written instructions related to operational
activities, the product/service, the quality system, and the
desired work culture (e.g., team building, communication,
change, behavior).”
27
Likewise,
Sterile Drug Products Produced by Aseptic
Processing
suggests that:
. . . fundamental training topics should include aseptic
technique, cleanroom behavior, microbiology, hygiene,
gowning, patient safety hazards posed by a non-sterile
drug product, and the specifi c written procedures
covering aseptic manufacturing area operations.”
28
Also, the
Guideline for Quality Assurance in Blood
Establishments
suggests that training topics may be derived
from a review of
. . . management observations, profi ciency test results,
competency evaluations, technical changes, error/
