QUALITY ASSURANCE ASSIGNMENT

“GOOD MANUFACTURING PRACTICES”

Prof T Padayachee

Venusia A NTSONO B
222614730

23/10/2023

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 TABLE OF CONTENT

HEADINGS PAGE NUMBERS

I. INTRODUCTION 3
II. DISCUSSION AND VIDEO 4-5
SUMMARY
III. CONCLUSION 5
IV. REFERENCES LIST 6

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 I. INTRODUCTION

Quality assurance, one of the main objectives of contemporary industry, covers all quality-
based functions throughout the life cycle of the product and process. It is evident that an
information system is essential to support all quality-based tasks from pre-production to post-
production in order to design and manufacture the proper products for customers. (Nookabadi
and Middle, 2006).
In order to achieve maximum effectiveness and complete customer quality satisfaction, the
integrated quality assurance information system aims to integrate all phases, from initial
identification to final realization of needs and customer expectations. (Nookabadi and Middle,
2006).
Near-perfect quality is necessary to succeed in today's fiercely competitive global economy.
Customers expect flawless products, even though most established firms run their processes at
relatively low faults per million opportunities. To build a more cohesive strategy in the quality
domain, most established firms have combined lean production, business excellence, standards
compliance, Six Sigma (a quality-control methodology developed in 1986 by Motorola, Inc.),
design for Six Sigma, and other quality-oriented ideas. In addition to being a research issue,
the identification of these uncommon quality events offers a chance to improve production
quality. (Escobar et Morales-Menendez, 2018).

In the pharmaceutical industry, every health service will definitely be harmed if there is no
guarantee that the medications are appropriate to high-priority health requirements and that
they adhere to recognized criteria of quality, safety, and efficacy. A significant amount of
administrative and technical work is done in developing countries to guarantee that patients
obtain high-quality, effective medications. Ensuring that every nation has access to a
dependable medication control system is crucial to achieving the goal of universal health.
(WHO, 2007).

The rest of this report will highlight the importance of Quality Assurance and Good
Manufacturing Practices in the Pharmaceutical and Biotechnology Industry as exposed in the
given YouTube video posted by Inglasia Pharma Solutions.

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 II. DISCUSSION AND VIDEO SUMMARY

Despite the fact the presenter was too fast and didn’t provide enough clarity under each heading
because of the use of professional terms, which made the understanding complicated, the video
was still useful in outlining the importance of GMPs.

Quality Assurance in the Pharmaceutical and Biotechnology industry is important because it

helps ensure the medicine is safe and of good quality. Pharmaceutical quality management
systems (PQMS) support the manufacturing and testing activities by implementing processes
that support operation activities such as:

1. Quality management
Pharmaceutical tree Ltm (consists of both roots and the rest of the tree).
-Roots: sustain the business on a daily basis and make it profitable. It is composed of both
quality and management. Quality consists of policy, site master file, quality manual,
management review, and new product introduction (NPI). Management incorporates
APR/PQR, CAPA, change control, and quality risk management (QRM).
-Branches: are related to manufacturing, support function, packaging, quality control, and
warehouse.

2. Personnel
Concerning the personnel, HR and staff work on board and receive proper training. The job
description is signed by the Head manager. They receive initial and ongoing GMP training and
everyone working at the company should have training files.

3. Documentation
It can be paper or electronic. A specific person should be assigned to the duty of data recording
to keep track of records, validation of documents, procedures, etc… in case of future changes,
for control, and data integrity.

4. Premises and equipment

It should be installed according to the type of manufacturing done. Documents showing the
state of each equipment and computer should be available in case clients or auditors would like
to control their suitability for the business. Water sampling, temperature, and other parameters
need to be appropriate according to the type of manufacturing done and safe from
contamination. Also, maintenance or cleaning, and pest control need to be implemented as well
as a good security service such as CCTV.

5. Operations
The operation consists of ensuring that the manufacturing process and storage are correctly
done.

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 6. Contracted services
They include vendors, suppliers, transportation providers, and everyone who has direct or
indirect power over the business based on a contract and who participates in its development.

7. Inspection
Those working by the inspection check how the business operates internally. Health authority
inspections need to be regular to ensure compliance with GMP. Clients can also inspect if
desired.

8. Incidents
No business is free from incidents. They can either happen at the beginning of the production
process (contamination of raw materials or ingredients) or at the end.

III. CONCLUSION

Overall, GMP and Quality Assurance are important in the manufacturing environment to
guarantee products are reliably monitored in accordance with quality standards in order to
lower the risks that cannot be removed by testing the finished product and to guarantee that it
is pure and effective for ingestion.
Though they are extensively used in non-pharmaceutical industries, several modern
approaches, like lean manufacturing, Six Sigma, and total quality management, have only
lately been introduced to the pharmaceutical sector. Managers in the pharmaceutical sector
and academic literature alike should concentrate on the adoption of such practices in the
pharmaceutical industry. To demonstrate that these methods are feasible, more case studies
ought to be conducted. (Haleem et al, 2025).
In order to provide quality assurance, good practices are implemented throughout all healthcare
companies through a methodical and thorough quality effort in labs, production setups, and
clinical facilities. Information about the implementation patterns of each GMP sub-parameter
in a particular section of a healthcare organization, such as a contraceptive. Any organization's
regulatory inspection of its GMP parameters will pay close attention to how well the parameters
perform in key areas like the premises, facility, and process. To produce the intended
environmental change, this is accomplished by modifying the process variable's control factor
to the appropriate level. (Jha et al, 2011).

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 IV. REFERENCES LIST

1. Escobar, C. A., & Morales-Menendez, R. (2018). Machine learning techniques for quality
control in high conformance manufacturing environment. Advances in Mechanical
Engineering, 10(2), 1687814018755519.
2. Haleem, R. M., Salem, M. Y., Fatahallah, F. A., & Abdelfattah, L. E. (2015). Quality in the
pharmaceutical industry–A literature review. Saudi Pharmaceutical Journal, 23(5), 463-
469.
3. Jha, P. K., Jha, R., Datt, R., & Guha, S. K. (2011). Entropy in good manufacturing system:
Tool for quality assurance. European Journal of Operational Research, 211(3), 658-665.
4. Nookabadi, A. S., & Middle, J. E. (2006). An integrated quality assurance information
system for the design‐to‐order manufacturing environment. The TQM
Magazine, 18(2), 174-189
5. World Health Organization. (2007). Quality assurance of pharmaceuticals: a compendium
of guidelines and related materials. Good manufacturing practices and inspection (Vol. 2).
World Health Organization.

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