(published in Dec 2018)
The purpose of this guidance is to
clarify the role of data integrity in current good manufacturing practice (cGMP)
for drugs, as required in 21 CFR parts 210, 211, and...
Production/manufacturing:- All operations involved in obtaining a product from the receipt of materials through processing to packaging and labelling.
Quality Control Unit:- It is the department designated as responsible for the certification of quality of...