Biomedical Engineering Reference
In-Depth Information
Figure 7.1
Applicable cGMP requirements
Table 7.1
Written procedures required in 21 CFR 211
Regulation
Topic
§211.22(d)
Responsibilities of quality control unit
§211.56
Sanitation
§211.67(b)
Equipment cleaning and maintenance
§211.80(a)
Control of components, containers, and closures
§211.100
Production and process controls
§211.101
Charge-in of components
§211.110(a)
In-process sampling and testing
§211.113
Control of microbiological contamination
§211.115(a)
Reprocessing
§211.122(a)
Materials examination and usage criteria
§211.125(f)
Labeling issuance
§211.130
Packaging and labeling operations
§211.142
Warehousing procedures
(
Continued
)
