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