| dc.rights.license | All rights reserved | en_US |
| dc.contributor.advisor | Torres, Edgar | |
| dc.contributor.author | Medina, Jesús M. | |
| dc.date.accessioned | 2020-09-28T11:35:31Z | |
| dc.date.available | 2020-09-28T11:35:31Z | |
| dc.date.issued | 2014 | |
| dc.identifier.citation | Medina, J. M. (2014). Applying a quality risk management approach to a cleaning validation system [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico. | en_US |
| dc.identifier.uri | http://hdl.handle.net/20.500.12475/780 | |
| dc.description | Design Project Article for the Graduate Programs at Polytechnic University of Puerto Rico | en_US |
| dc.description.abstract | Cleaning Validation is a crucial step
on assuring product effectiveness and safety by
assuring that the equipment to be used has the
appropriate condition to manufacture a new
product without any foreign substances that could
endanger the patient to ingest this product. A
quality risk management approach was used to see
possible risks on a cleaning validation system and
give recommendations in order to mitigate and
control those the risks by seeking options to
access does risks in an effective and reliable
manner. FDA 21 CFR 210-211 was used as a
guide for regulations regards cleaning validation
systems.
Key Terms - Cleaning Validation, FMEA,
PAT, Quality Risk Management. | en_US |
| dc.language.iso | en_US | en_US |
| dc.publisher | Polytechnic University of Puerto Rico | en_US |
| dc.relation.ispartof | Manufacturing Engineering; | |
| dc.relation.ispartofseries | Spring-2014; | |
| dc.relation.haspart | San Juan | en_US |
| dc.subject.lcsh | Pharmaceutical industry--Production standards | |
| dc.subject.lcsh | Pharmaceutical industry--Equipment and supplies--Cleaning | |
| dc.subject.lcsh | Pharmaceutical technology--Quality control | |
| dc.subject.lcsh | Risk management | |
| dc.subject.lcsh | Polytechnic University of Puerto Rico--Graduate students--Research | |
| dc.title | Applying a Quality Risk Management Approach to a Cleaning Validation System | en_US |
| dc.type | Article | en_US |
| dc.rights.holder | Polytechnic University of Puerto Rico, Graduate School | en_US |
