Equipment Hold-Time for Cleaning Validation - Pharmaceutical Technology

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Equipment Hold-Time for Cleaning Validation
Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.


Pharmaceutical Technology


Conclusion

If clean- and dirty-equipment hold times are established during validation and maintained under properly defined and controlled conditions, the need to monitor clean- or dirty-hold times is not necessary. Avoiding these steps can result in savings of time and resources as well as potential regulatory exposure.

Richard J. Forsyth is an associate director of worldwide GMP quality with Merck & Co., Inc, WP53C-307, West Point, PA. 19486, tel. 215.652.7462, fax 215.652.7106,

Submitted: Nov. 16, 2007. Accepted: Dec. 20, 2007.

References

1. FDA, Guide to Inspection of Validation of Cleaning Processes, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs (Rockville, MD), July 1993.

2. EU, Annex 15, European Union Guide to Good Manufacturing Practice, Working Party on Control of Medicines and Inspections, European Commission (Brussels, Belgium), July 2001.

3. Health Canada, Cleaning Validation Guidelines (Guide-0028), Drug GMP Inspection Unit (Ottawa, Ontario) May 2000.

4. "Recommendations on Validation Master Plan Installation and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation," in proceedings of the PIC/S (PIC/S, July 2004).

5. R. J. Forsyth and D. Haynes, "Cleaning Validation in a Pharmaceutical Research Facility," Pharm. Technol. 22 (9), 104–112, 1998.

6. J. A. Morales Sanchez, "Equipment Cleaning Validation Within a Multi-Product Manufacturing Facility," BioPharm Inter. 31 (2), 38– 49, 2006.

7. A. H. Mollah, "Risk-Based Cleaning Validation in Biopharmaceutical API Manufacturing," BioPharm Inter. 30 (11), 54–68, 2005.

8. T. Fugate, "Hold Time Studies: A Lost Parameter for Cleaning Validation," J. Val. Technol. 13 (3), 206–209, 2007.


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