China
Africa
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Globalising Ayurveda, branding India
Published in Stephan Kloos, Calum Blaikie, Asian Medical Industries, 2022
Moreover, Ayurveda’s path to GMP has been relatively free of the epistemological conflicts described elsewhere (e.g. Craig 2011). The focus has been mainly on creating hygienic storage and processing environments and instituting batch-wise documentation and quality testing. Manufacturers continue to follow in-house production protocols, while state pharmacopeia and formularies are not considered binding. As Banerjee (2002) notes, GMP have also been sensitive to system-specific requirements. In fact, a recent AYUSH-commissioned report recommends that the exemption given to Ayurvedic doctors and hospitals be extended to artisanal units focused exclusively on supplying medicines to Ayurvedic doctors (Chandra 2011: 246–247). Moreover, inter-country variability in standards is common, given that GMP guidelines provide for flexibility in adaptation. Even in countries such as China and Japan, which are stringent in enforcing GMP, regulations have been tuned to meet the needs and constraints of the industry in the domestic market (see Chee; Arai et al., this volume). Observing the wide variation between GMP standards in different countries, Saxer (2012: 499) points out that “although GMP bears all the marks of a global form, it is important to stress that it is neither Western nor an international standard.”
Ethics of Medical Product Development
Published in Howard Winet, Ethics for Bioengineering Scientists, 2021
The MDAs were extended in 1978 to include regulations directed at device manufacturing. The new regulations called the Good Manufacturing Practices (GMP) program covered the manufacture, packaging, storage, distribution, and installation of medical devices. This program of quality assurance allowed the FDA to inspect a device manufacturer’s operation and require correction of any regulation violations before the product could be shipped. It has been proposed that no program has had a greater effect on the industry than the GMP (Fries 2005).
Microbial Monitoring of a Manufacturing Facility
Published in Philip A. Geis, Cosmetic Microbiology, 2020
Control of microorganisms within a manufacturing facility is a critical quality parameter of cosmetic/personal care products industry. These products is not expected or required to be sterile, but the presence of excessive numbers of microorganisms or pathogenic/objectionable microorganisms is not acceptable. Good manufacturing practices (GMPs) are typically established to put in place controls that prevent microbial contamination during manufacturing. In order to confirm microbiological control, microbial monitoring is performed on critical portions of a manufacturing facility including environmental air, equipment and facility surfaces, and manufacturing systems.
Genetic modification and preconditioning strategies to enhance functionality of mesenchymal stromal cells: a clinical perspective
Published in Expert Opinion on Biological Therapy, 2023
Kasra Moeinabadi-Bidgoli, Radman Mazloomnejad, Alireza Beheshti Maal, Hamid Asadzadeh Aghdaei, Mandana Kazem Arki, Nikoo Hossein-Khannazer, Massoud Vosough
Good manufacturing practice (GMP) is defined as performing preparation procedures and quality control under certain standards. GMP is compulsory under the FDA, Health Canada, and European Medicines Agency (EMA) [123]. As cell therapy products (CTPs) could be considered as drugs, they must follow GMP protocols to ensure safety, resemblance, and efficacy. As CTP has complex and ambiguous impacts and mechanisms of action, defining GMP protocols for CTPs is a challenging task that needs to be addressed [136]. It appears that for every particular disorder, a specific preconditioning inducer has a preferable efficacy to boost MSC-based therapy. For instance, IFN-γ preconditioning appears to be a more suitable method to boost MSCs’ therapeutic potency in inflammatory and autoimmune disorders, while hypoxic preconditioning seems to be a more appropriate strategy to enhance MSCs’ therapeutic potential in ischemic diseases. In order to establish a GMP protocol for MSC-preconditioning, first of all it seems essential to consider preconditioning as an obligatory step for CTP manufacturing protocols as preconditioning is feasible, cost-effective, and is shown to improve the cells’ survival, resistance against environmental harassments, trophic, and anti-apoptotic factor secretion, and engraftment. Moreover, a particular preconditioning protocol including the inducer, the dose of the inducer, and timing should be defined for each disorder in which CTP is going to be utilized.
Comparison of the registration process of the medicines control authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: benchmarking best practices
Published in Expert Review of Clinical Pharmacology, 2022
Tariro Sithole, Sam Salek, Gugu Mahlangu, Stuart Walker
Labeling issues must be addressed before a product is authorized in all five agencies. At the MCAZ, responsibility for the marketing authorization decision lies with the Registration Committee. The Director General makes the decision on registration for Health Canada and HSA, whereas for TGA, the responsibility is delegated to a senior medical officer, and at Swissmedic the decision is made by the case team with the involvement of the Head of Division/Sector. In all five agencies, compliance with GMP is audited during the review process and the outcome informs product authorization. The target time for the overall approval for a full review for the MCAZ is 480 days, inclusive of the applicant’s time and this is comparable to the target times for the comparator countries: TGA, 330 days including the applicant time; Health Canada, 355 days excluding applicant time to respond to an NOD and any other approved pauses, ranging from 5 to 90 days; HSA, 378 calendar days excluding the queue and applicant time; and Swissmedic, 330 days excluding the applicant time (Table 2). The target times are comparable because the 480 days for MCAZ includes the applicant’s time. If the applicant’s time (target 60 days per assessment cycle for 2 cycles) was to be excluded, this would come down to 360 days.
Effects of different air change rates on cleanroom ‘in operation’ status
Published in Drug Development and Industrial Pharmacy, 2021
Detlef Behrens, Jens Schaefer, Cornelia M. Keck, Frank E. Runkel
For the operation of cleanrooms, large amounts of energy are consumed compared to non-cleanrooms [8–10]. Heating, ventilation and air conditioning (HVAC) systems for pharmaceutical cleanrooms can have up to 25 times higher energy demands than standard rooms [8]. The focus of regulatory requirements in ‘Good Manufacturing Practice’ (GMP)-regulated environment, however, is always on patient, and product, as well as operator safety, and not on energy efficient production. The obligation to meet the guidance values leads to strict decisions in many pharmaceutical companies: Cleanrooms are operated 24 h with a constant ACR, independent from actual use [11]. Furthermore, the defined ACR is often designed higher than actually needed, which again leads to an increased energy demand of up to 50–75% of the total facility energy consumption [12]. The reason for his is an over-interpretation of regulatory guidelines, which are generic and do not reflect specific cleanroom process conditions [8]. The operating companies do not always know which ACR is required for a specific room, and, thus, decide to design the air handling unit (AHU) on the ‘safe side’, with higher ACRs for the cleanrooms than technically required [12]. Opportunities for energy saving by a correct and not overdesigned setting of ACR per individual cleanroom are thereby missed.