Regfo
Module 3qualitynda

3.2.A.1 — Facilities and Equipment

Facilities and equipment description (applicable to biotech products)

Requirements by Phase

Phase 1
N/A
Phase 2
N/A
Phase 3
N/A
NDA
conditional

Facilities and equipment description (applicable to biotech products)

Requirements by Phase

NDA: conditional

Content (Biotech)

  • Manufacturing flow diagram showing movement of raw materials, personnel, waste, and intermediates
  • Description of adjacent areas and their functions
  • Product-contact equipment description (dedicated or multi-use)
  • Cleaning, sterilization, and storage procedures for equipment
  • Procedures to prevent contamination and cross-contamination

Expected Deliverables

  • Facility layout flow diagram
  • Equipment list (dedicated/multi-use)
  • Contamination prevention procedures summary

ICH Guidelines: Q5A, Q5D

Note: Biotech only

Source: ICH Q5A

References

ICH Q5A

Related Sections

Up to3.2.A — Appendices (Quality)
3.2.A.2 — Adventitious Agents Safety Evaluation

Adventitious agents safety evaluation for biotech products

3.2.A.3 — Novel Excipients

Safety data package for novel excipients

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