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Alternatively, one might advocate the implementation of GMP requirements only in a few selected centres.
The present study suggested that the implementation of GMP regulation facilitates the transformation of local medical device industry.
Nepali regulators and producers state that implementation of GMP standards is hindered by low regulatory capacity, insufficient training of staff in the industry, financial constraints and lack of investment for upgrading capital.
By analyzing the transition of the medical device manufacturer association in Taiwan after the implementation of GMP regulation, it helps us to understand how quality of medical device manufactured in Taiwan was enhanced as a result of the implementation of the GMP regulation.
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Investigational drug GMP(12) and its Q&A(19) may be referred to in the implementation of GMP-based control of the investigational drug.
The key criterion in this case is that the TTC is not being used in lieu of the implementation of GMPs or of a comprehensive HACCP plan; it can be considered only after confirming that all relevant food safety measures are fully implemented in the processing chain and the facility at large.
The WHO has made clear that the implementation and enforcement of GMP is a matter for individual states and their respective drug regulatory bodies which can specify different sets of requirements.
It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement.
In this paper we provide a brief background to GMP reported studies on the impact of GMP on local production before using the case study of Nepal to explore GMP implementation and enforcement from regulators' and producers' perspective in the context of development aid and aid conditionalities.
In a previous proof-of-concept paper, we have reported that a GMP-compliant implementation of cord-blood- (CB-) derived CD133+ cells for cardiovascular repair does not alter the angiogenic potency in vitro and in vivo [ 26].
OP44 Implementation of a GMP-grade radiopharmacy facility in Maastricht.
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