Preparing for FDA Cosmetic Manufacturing Facility Inspections?

FDA Cosmetics Manufacturing Facility Audit Preparation, Help from J&B

The FDA conducts audits on overseas cosmetics manufacturing facilities based on Good Manufacturing Practices (GMP) regulations.

Failure to comply with these regulations during an audit could lead to the cancellation of the factory’s registration.

With the implementation of MoCRA, it is expected that audits will become even more stringent.

Key Audit Checklist for Cosmetics (OTC functional products are subject to separate OTC regulations)

Documentation

Purpose: Ensure accuracy and traceability in the manufacturing process.

Requirements: Detailed records of procedures, deviations, justifications, guidelines, specifications, protocols, reports, methods, preventive actions, corrective actions, and other relevant information.

Record Management

Format: Records can be in paper or electronic form.

Content: Records must include raw materials, disposal of rejected materials or returned products, batch production control records, and finished product control status (acceptance or rejection).

Buildings and Facilities

Design: Adequate size, design, and construction.

Maintenance: Clean and organized maintenance.

Facility: Proper lighting, ventilation, plumbing, washing, cleaning, and sanitation facilities.

Equipment

Design and Maintenance: Equipment must be of appropriate design, size, and material, kept clean and organized.

Calibration: Equipment must be calibrated or inspected regularly in accordance with Standard Operating Procedures (SOPs).

Personnel

Qualifications: Personnel must have the necessary education, training, and experience.

Hygiene: Adhere to personal hygiene protocols to prevent contamination.

Raw Materials and Production

Management: Raw materials (including water and color additives) must be managed to ensure quality and regulatory compliance.

Process: Measures must be taken to prevent contamination and ensure product consistency.

Laboratory Management

Testing: Raw materials, in-process, and finished product samples must be tested for identity, compliance, microbial contamination, and other risks.

Storage: Approved lot samples must be stored under conditions that protect their integrity and must be periodically retested.

Internal Audits

Procedure: Regular internal audits must be conducted by independent personnel.

Compliance: Verify whether activities are meeting planned requirements and objectives.

Prohibited and Restricted Ingredients

Regulations: Comply with specific FDA regulations regarding prohibited and restricted ingredients in cosmetics.

By following these guidelines, manufacturers can ensure product safety and meet quality standards while minimizing risks of contamination or improper labeling.

For perfect audit preparation, it is recommended to seek advice from experienced J&B Consulting.

Feel free to contact us

jay@jnbfoodconsulting.com or 714-873-5566