21 CFR Part 129 Subpart A – General Provisions

Current good manufacturing practice (cGMP)

21 CFR Part 129 Subpart B – Buildings and Facilities

Plant construction and design

• • • Bottling room
    • Sealed system under pressure
    • Ventilation
    • Washing and sanitizing room
    • Processing room

Sanitary facilities

• • • Product water
    • Operations water
    • Air under pressure
    • Locker and lunchrooms

Sanitary operations

• • • Product water-contact surfaces
    • Multiservice containers
    • Equipment and utensils
    • Pipes
    • Single-service containers
    • Caps and seals

Equipment and procedures

• • • Collection and storage tanks
    • Piping
    • Fittings
    • Connections
    • Bottle washers
    • Fillers
    • Cappers

Production and process controls

• • • Treatment of product water
    • Containers
    • Cleaning and sanitizing solutions
    • Sanitizing operations
    • Unit package production code
    • Filling, capping, or sealing
    • Bacteriological analysis
    • Chemical analysis
    • Physical analysis
    • Radiological analysis
    • Record retention