Module 4 of the GMPify Part 211 Certification Series covers Subparts F 

and G the production and packaging controls that directly govern 

day-to-day manufacturing operations. This module addresses written 

procedure requirements and deviation documentation under §211.100, 

two-person component verification requirements under §211.101, actual 

versus theoretical yield calculation and investigation under §211.103, 

equipment identification requirements under §211.105, in-process 

sampling and testing under §211.110, time limitations and sterility 

assurance under §§211.111 and 211.113, reprocessing controls under 

§211.115, and the complete labeling control suite; receipt, issuance, 

reconciliation, line clearance, and gang printing prohibition under 

§§211.122 through 211.130. Tamper-evident packaging and expiration 

dating requirements are also covered.

Labeling errors are among the leading causes of drug recalls. This 

module dedicates significant attention to label control as one of FDA's 

highest inspection priorities.

Suitable for: Manufacturing operators, production supervisors, 

packaging personnel, QA, and anyone involved in batch record 

completion and review.

Approx. 30 minutes | 5 assessment questions | Certificate on completion

Source: 21 CFR Part 211 Subparts F & G, eCFR