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A company may also seek an 'advisory inspection,' where a standard fee is paid to NAFDAC for advice from an inspector on GMP requirements and for recommendations of measures to improve GMP compliance at that site.
Propagation of CEnCs for this study was achieved using a dual media culture system23, refined towards GMP compliance as described27.
Additionally, the book discusses GMP compliance in stem cell facilities and the manufacture of stem cells for clinical translation.
The current requirements for the production of radiopharmaceuticals in GMP compliance have made the clinical use of 18F-galacto-RGD difficult.
The APEC economies that are PIC/S members could utilize the PIC/S network and common high standards to make significant positive moves towards greater convergence in GMP compliance assessment and conduct of inspections.
GMW, NR and NR manufactured, ensured GMP compliance and issued cells from the bank.
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Ugandan producers argue that the increased donor funding towards essential medicines combined with the requirement of WHO-GMP compliance means that "they are slowly being pushed out of the local essential medicines market" and some suggest that this "might be the single biggest threat to the survival of local pharmaceutical manufacturing" [ 23 ].
The MHRA certified compliance with GMP and awarded a 'Specials' Licence, allowing the release of an Advanced Therapy Medicinal Product ATMPP) in October 2011.
Belgian Banks for Human Body Material have already invested heavily in clean room facilities and are getting ready to produce hTEPs in compliance with GMP requirements, even though there is no evidence that these investments will actually result in any significant improvement to the quality or safety of their grafts.
Although compliance with GMP is a condition of market entry, as well as conferring production rights for many essential medicines procured though international donors, there has been little analysis of the impact of international GMP standards on local production for public health systems and government use.
However, UNICEF does not issue GMP licences nor GMP certificates following these GMP inspections.
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