Good Manufacturing Practices in Bio-Pharma and MedTech Industry

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Good Manufacturing Practices in Bio-Pharma and MedTech Industry
Introduction
Bio-Pharma and MedTech industry are always in a need of a standardization of the services
and products because they deal with products that are urgent in nature and mistakes of the
products or the goods can become fatal.This urgency instigates the concept of GMP or Good
Manufacturing Practices in the Bio-Pharma and MedTech Industry (Karmacharya, 2011). In
order to achieve the highest standards of the manufacturing certain functions are prescribed
by competent authorities of the world that are taking care of the GMP based operations.
Functions
Total Quality Management with an eye for the standards
The basics of the GMP clearly prescribe the needs of following the right kind of procedures
while producing the goods. For instance, we can take the example of various chemical
processes associated with the drugs (Gross, 2015). Any shortcoming in the processing can kill
the essence of the final mixture. This is why most of the units following the GMP often make
sure to install quality checks at various steps of the manufacturing. Ideally, these quality
checks should be done on a unit basis where the lab can test each and every lot or the unit for
the shortcomings (Dunning, 2017).
Another issue is related to the standards. It has been observed that most of the patent holders
follow certain standards to deliver the final product. However, once the drug or the
technology become generic then new manufacturers find it difficult to maintain the standards
set by various authorities. Adherence to GMP is needed at all levels. Three main associations
are already working in the world with an intention to check the GMP guidelines at an
international level (Uddin, 2017).
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Regulations
Pharmaceutical companies are bound to abide by the regulations prescribed by various
competent authorities. Most of these regulations come into force after striking compliance
with certain evidence-based practice (Basant, 2012). The practice of GMP is dependent on the
function of the regulations because they serve as a guideline and checklist for the
manufacturers. These regulations set certain practices and raw materials as the benchmark
prior to the start of the production. Once the production begins then these regulations keeps a
check on the quality of the sub-products on a component basis (Mattess, 2017).
Impact of GMP
Medical science is dependent on the feedbacks and constant study of the results of any given
medicine or solution (Kumar, 2010). GMP sets the right standards for the medicines and their
performance. Most of the manufacturing experts think that the role and impact of the GMP
are confined to the final performance of the product (Rahalkar, 2012). However, in the case of
Pharmaceuticals and health care industry, the impact of GMP can also be seen on the
feedback chains. For instance, the quality of the drug made in a first world country may vary
in comparison with a drug made in a third world country. Most of the first world countries
follow strict regulations related to the GMP (K.Patel, 2011). Whereas the manufacturers in the
third world countries follow them as a formality, the function of TQM can act as a burden on
them. This absence of strict TQM regime reflects on the price and performance of the drug.
Third world countries want to deliver economic solutions whereas first world countries focus
more on immaculate performance (Rauschnabel, 2018). This difference in the approach works
as a big variable in setting up global GMP standards. Many studies done in different part of
the world gives us empirical data about this difference and establishes the impact of GMP
over the final products (Haider, 2011). However, the mechanisms to measure GMP practices
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