Module 2 of the GMPify Part 211 Certification Series covers Subparts C 

and D the physical environment requirements for GMP-compliant drug 

manufacturing. This module covers facility design and construction 

requirements under §211.42 including the absolute requirement for 

separate penicillin facilities, lighting, ventilation, HVAC, plumbing, 

sanitation and maintenance requirements under §§211.44–211.58, equipment 

design, size, and location criteria under §211.63, product contact 

surface material requirements under §211.65, equipment cleaning and 

maintenance procedures and validation under §211.67, and automated and 

computerised equipment controls under §211.68.

Data integrity requirements linked to §211.68 and their relationship 

to 21 CFR Part 11 are specifically addressed, along with the most 

frequently cited 483 observations in facility and equipment audits.

Suitable for: Engineering, validation, facilities management, QA, 

manufacturing operations, and IT teams supporting GMP systems.

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

Source: 21 CFR Part 211 Subparts C & D, eCFR