Non-compliance with GMP guidelines can lead to costly product recalls, lawsuits, and damage to the company’s reputation. The following are some of the common GMP violations and how to avoid
them:
1. Poor Documentation
Poor documentation can lead to incomplete or inaccurate records, making it difficult to trace products or identify the cause of any problems. To ensure good documentation, ensure that all documentation is clear, accurate, and easily retrievable.
2. Inadequate Training
Inadequate training can lead to errors in the manufacturing process, resulting in non-compliance with GMP guidelines. To avoid insufficient training, ensure that all personnel involved in the manufacturing process are trained and qualified for their specific
roles.
3. Equipment and Facility Issues
Equipment and facility issues can lead to contamination and non-compliance with GMP guidelines. To avoid equipment and facility issues, ensure that all equipment is qualified, validated, and maintained and that the facility is designed and constructed to prevent contamination.