6. Failure to properly train persons in charge of sampling:
- This can have a major impact on the accuracy of microbiological sampling.
7. Not having an effective change control program:
- Once the validation process is completed, internal procedures impacted by the validation outcomes must be revised accordingly.
It is frequently observed that the communication and follow up systems fail at some point and impacted procedures and activities
are not modified.
8. Not having an adequate cleaning monitoring system:
- It is frequently observed that changes are made to an already validated system, disregarding the impact those changes might
have on the validation state of the total system. Constant communication between manufacturing and the validation department
9. Failure of manufacturing areas to consider the validation department in internal changes and procedure approval:
- Due to lack of technical knowledge in the validation area personnel in manufacturing might overlook or be unaware of important
aspects that have impact from a validation point of review.
10. Failure of plant personnel primarily focused on the manufacturing operation, to require compliance with the cleaning validation
José A. Morales Sánchez is a technical services senior scientist at Janssen Ortho LCC a Johnson ' Johnson Company; 787.272.7463; firstname.lastname@example.org
1. FDA. "Guide to Inspectors of Validation of Cleaning Procedures," 1993.
2. Technical Tip #3020. "Pharmaceutical Product Contact Surface Sampling." Steris Corporation (Calgon Vestal Division), 410-200-3020.
3. PDA Pharmaceutical Cleaning Validation Task Force, "Points to Consider for Cleaning Validation," Journal of Pharmaceutical
Science and Technology, Technical Report No. 29, Volume 52, Number 6, 1998.
4. Maria J. Capote, "Documentation For Cleaning Validation: A Protocol Template," pgs 261-271, Volume 2-Number 3, Journal
of Validation Technology.
5. Gil Bismuth and Shosh Neumann, "Cleaning Validation: A Practical Approach," Interpharm Press, 2000.
6. Health Products and Food Branch Inspectorate, "Good Manufacturing Practices - Cleaning Validation Guidelines," Spring
7. Destin A. LeBlanc. "Equipment Cleaning Validation: Microbial Control Issues," Journal of Validation Technology, Volume
8, Number 4, August 2002.
8. Herbert J. Kaiser and Maria Minowitz. "Analyzing Cleaning Validation Samples: What Method?" (http://
http://www.ivthome.com/free/analyzing_cleaning_validation_samples.htm, accessed July 16,2003).
9. Code of Federal Regulations Title 21, Volume 4, Section 211.67, April 2004.