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Production in Practice What Does It Take To Be A Good Manufacturer

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Name: Quenne A.

Belocura

Subject/Code: CHE540FL/10489

REFLECTON

Title: Production in Practice: What does it take to be a good manufacturer?

For webinar 3, our speaker, Engr. Ria Ela Alexandra Quemada thought us lot of things. The
following are some of those things: Good manufacturing practices (GMP), pillars of GMP,
HACCP, and many more.

First is the GMP, it is a quality assurance aspect that ensures that pharmaceutical products are
manufactured consistently, comply with quality standards appropriate for the intended use, and
are required by product specifications. It define quality standards for both production and quality
control, clearly define, validate, review and document the processes required for production and
testing, and ensure that personnel, facilities and materials are suitable for the production of
pharmaceuticals and biologics.

It is important to learn about GMP as a future chemical engineer for poor quality medicines may
contain toxic substances that have been added unintentionally. Drugs that contain little or no
claimed ingredients do not have the intended therapeutic effect. Good Manufacturing Practices
(GMP) is a system that ensures that products are consistently produced and controlled in
accordance with quality standards. It is designed to minimize the risks associated with drug
manufacturing that cannot be ruled out by final product testing.

Second topic we discussed is the pillars of GMP: People, process and procedures, premises, and
products. All of these Ps are intended to support the quality and consistency of the final product
used by consumers. And it is an end-to-end responsibility to ensure that the goods that enter and
leave the facility are properly organized and handled properly. For example, the manufacturer
must have specifications for all raw materials and components used. Overall, we need repeatable
methods for research, development, processing, manufacturing, packaging, testing, sampling,
status management, stability testing, and records management.
Next we discussed about the Hazard Analysis Critical Control Point (HACCP). HACCP is a
management system that works on food safety through analysis and management of biological,
chemical and physical hazards from raw material production, procurement and handling to final
product manufacturing, distribution and consumption. HACCP is important because it prioritize
and manage potential hazards in food production, management of major food risks such as
microbiological, chemical and physical pollutants, it provides a framework for producing food
safely and proving that it was produced safely, it’s focus is on prevention and management of
potential food safety hazards, not testing, and many more.

All in all, we have learned a lot during the webinar, things that we can use in the future.

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