1. GMP Facility Layout Principles
Korean cosmetics GMP requires a logical flow from raw materials to finished goods with no cross-contamination pathways. Key zones: receiving, raw material storage, weighing, manufacturing, filling, packaging, finished goods storage, and QC laboratory.
2. Zone Separation Requirements
- Raw material and finished product storage must be physically separated
- High-risk manufacturing areas (emulsification, etc.) require controlled environments
- Personnel flow must prevent contamination (changing rooms, airlocks)
3. Air Quality and Cleanliness
- Cleanroom classifications per ISO 14644 for specific product types
- HEPA filtration required for sterile or near-sterile products
- Regular environmental monitoring (particle counts, microbial)
4. Documentation Requirements
- Standard Operating Procedures (SOPs) for each manufacturing step
- Batch manufacturing records
- Equipment cleaning and calibration records
- Environmental monitoring logs
FAQ
Q. Is GMP mandatory for all cosmetics manufacturers?
A. GMP compliance is required for registration, and formal GMP certification is mandatory for exporters to many markets.
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