A Comprehensive Report on Good Manufacturing Practices in Bio-Pharma

This report provides an overview of Good Manufacturing Practices (GMP) within the Bio-Pharma and MedTech industries, emphasizing the importance of standardization due to the critical nature of the products. It highlights the role of Total Quality Management (TQM) and adherence to standards, referencing international associations that oversee GMP guidelines. The report discusses regulations imposed on pharmaceutical companies and the impact of GMP on medicine quality and feedback chains, noting differences in implementation between first and third world countries. It also explores the evolution of GMP through evidence-based practices and practitioner feedback, and how GMP can be effectively embedded in organizations, referencing FDA, EU, and WHO GMP standards and their harmonization efforts. The assignment concludes by referencing various articles.

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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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are not adequate. On most of the occasions, the authorities rely more on the performance of
the drug to ascertain the presence of GMP (Henry, 2018). Still, on a theoretical level, we can
say that GMP makes sure that the products serving in the Bio-Pharma and Med Tech industry
are at par with the needs and standards set by the institutions and GMP plays a keen role in
achieving these standards.
Question 2
The evolution of the GMP in Bio-Pharma and Med Tech Industry
GMP as a practice is a constant process where two fractions of the operational bodies play a
major role. Medical science has a culture of promoting evidence-based practices where they
keep a check on the performance of any product during the phase of its beta-testing. While
making these amendments or while developing these products inside a lab they set certain
norms related to the manufacturing. Each norm is an outcome of constant observations and
readings taken in a lab.
After the initial testing, this norm becomes a binding practice while developing a manual for
GMP practices. Manufacturers accommodate these bind practices in the manual and convert
them into a hard law associated with a GMP. The quality control department also takes note
of the final performance of that particular practice and checks it.
The second layer that confirms evidence-based practices is related to the practitioners. We
can understand it with the help of a blood glucose monitor. In general most of the end user-
friendly blood glucose meters claim that the variation in the results may go up to 20 percent.
Medical practitioners often go for an aftermath based exercise where they compare the results
of an end-user friendly blood glucose meter with professional readings. In case they find a
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variation beyond the claims on a regular basis then they can report it back to the manufacture
and manufacturer can instruct the research and development department for the same. This
consistent chain of feedbacks helps in the evolution of GMP's.
How GMP can be effectively imbedded in an organization dealing with Bio-Pharma and
Met-Tech
When we compare GMP regimes of a mobile manufacturer with a Bio-Pharma and Med-
Tech manufacturer then we find that it is different (Henry, 2018). A mobile manufacturer has
this luxury to improve the shortcomings in the next edition or invite a rollback. However, in
the case of Pharmaceutical companies and Med-Tech companies, this luxury is not present.
As a manufacturer, they cannot afford to practice a "just in case" scenario. They have to abide
by the "just in time" scenario. This is why a constant evolution in GMP regimes is always on
the cards for the players working in this industry (Gross, 2015).
In order to keep a strong check on GMP's most of the Med-Tech companies often check their
quality management tools from time to time with an intention to deliver the best goods.
Authorities like the FDA and others are always busy in the process of the Harmonization of
GMP standards for various states and countries (Haider, 2011). Three main standards of the
compliances in the field of the GMP go as follows.
1. FDA GMP standards
2. EU GMP standards
3. WHO GMP standards
These three organizations collect note with each other on a regular basis with an intention to
harmonize the GMP standards associated with various products.
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Bibliography
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Gross, J. (2015). Why GMP? An explanation of Good Manufacturing Practice. Fischer
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