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KMID : 1142220120070010083
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Regulatory Research on Food, Drug & Cosmetic
2012 Volume.7 No. 1 p.83 ~ p.89
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Study of Application Method for Medical Device in Packaging Validation
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Hwang Won-Koo
Kang Gyoo-Il
Song Moon-Yong
Hong Soo-Youn
Hur Su-Gil
Lee Won-Hoi
Hwang Sun-Jin
Ryeom Tai-Kyung
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Abstract
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Packaging process is a special process under the definition of GMP. That is, it shall be managed specially since the state of sterilization and product cannot be checked completely in the following inspection or test after packaging. The special management like this shall be started from the validation. Recently in case of the sterile product, the importance of packaging work process which maintains sterility and protects products together with the sterilization process is being highlighted. However, it is urgent to conduct a study on the guideline which can evaluate the safety and validity of packaging process since it is the actual situation in Korea not only that there is no guideline possible to evaluate the safety and validity of packaging process, but also that there is no practice case which is known widely. Therefore, we would like to develop the guideline which can be utilized at the site by reinterpreting current status on standards and studies in relation to the packaging at home and abroad through this study. Packaging validation may be referred to as the work checking the feasibility for the packed final product whether the process, facility or system functions properly as it was intended to with the objective evidence. This report would like to present practice cases such as various data analyses to perform the IQ (installation qualification), OQ (operation qualification), PQ (performance qualification) and packaging validation. The final objective of this research task is to build the guideline to packaging validation of medical devices which coincides with international standards and to reflect it to the screening and evaluation, etc. for the advancement in GMP operation of the medical device manufacturer. It is expected that the technological level of medical device manufacturer on GMP operation will be enhanced by preparing the guideline to packaging validation and practice standards through this study, and that it will contribute not only to the development of medical device industry, but also to the securement of health and safety of our people.
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KEYWORD
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MedicalDevice, GMP, Packaging, Validation, Guideline
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FullTexts / Linksout information
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Listed journal information
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