Introduction to the biomedical industry · Introduction to the Biomedical Industry Introduction to...

Introduction to theBiomedical Industry

Eileen Ruiz Perez, PhD

Introduction to the Biomedical Industry


Medical Products Manufacturing Industry

Hello! Thank you for joining us at this learning capsule, presented by Biobusiness Research!

We welcome you on behalf of our founder, Dr. Eileen Ruiz, and Biobusiness Research’s team of

collaborators.

In this capsule, we will be presenting a brief introduction to the medical products manufacturing

industry.

Let’s Start!

The Biomedical Industry

In this section, we will be presenting an introduction to the biomedical industry, with emphasis on the

manufacturer of medical products, such as the pharmaceutical, medical, and biotechnological products.

Let us start by defining What medical manufacturing industries are.

They are companies engaged in the manufacture, processing, packaging or distribution of Devices,

Medicines, Biological Products or Combination Products. In this sector, we find the medical device

industries, pharmaceuticals, biotechnology, and manufacturers of combined products, such as a

medical device with a drug. A company that that produces the serum bag, and the saline solution that

goes with the serum, is a good example of a combination product.

The bag containing the serum, plus, the tubes and accessory products, are considered medical devices.

The liquid containing the saline solution, could be considered the drug.

https://app.designrr.io/projectHtml/584956?token=ec62e3059942b189570b32d81ff5bced&embed_fonts=



These Organizations are regulated by various entities, depending on the market in which their products

are distributed.

Let’s introduce the pharmaceutical and medical devices sector.

. Most people are familiar with the pharmaceutical industry. This industry manufactures

the medicines or drugs that doctors prescribe to us, or that we acquire at the pharmacy.

Pharmaceuticals

Then, what is a drug or medicines?

We refer to drugs as chemical products used in the treatment, cure, prevention, or diagnosis of a

disease. They can also be used to improve physical or mental well-being.

These chemicals, when absorbed into the body, alter the normal functioning of the body.

It has its function based on chemical reactions in the body. Unlike medical devices, that its primary

mode of action is not related to the mediation of a drug or chemical, but a physical or mechanical

action.

Then, what is a medical device?

. A medical device is an object, device or product used for diagnostic or therapeutic

purposes.

Medical Devices

They usually have a physical or mechanical effect on humans or are used to measure or control body

functions. Its main mediation is by physical or mechanical effect, Not because of chemical reactions.




The World Health Organization, WHO, and the Food and Drug Administration, FDA, define a medical

device as an article, instrument, apparatus, or machine, used in the prevention, diagnosis or treatment of

a disease or condition, or, to detect, measure, restore, correct or modify the structure or function of the

body for health purposes.

Typically, the purpose of a medical device is not achieved by pharmacological, immunological, or

metabolic means.

The medical devices and technologies industry are diverse. We can find organizations that manufacture

surgical, dental, flossing, hospital beds, heart valves, insulin pumps, pacemakers, orthopedic screws,

defibrillators, intraocular lenses, and many more.

Another sector is related to the manufacture of biological products.

. Biological products are derived from living material, for example, microorganisms,

humans, plant, or animal tissue.

Biological Products

These products are used for the treatment, prevention, or cure of diseases.

They can replicate natural substances such as enzymes, antibodies, or hormones in our body as a mode

of action.

Some of these products may be composed of sugars, proteins, nucleic acids, or a combination of these

substances. They can be produced by biotechnological methods.

Some examples of biological products may include antibodies, interleukins, and vaccines.




The manufacturing industry of medical products, pharmaceuticals, devices, and biotechnological is

highly regulated. In the U.S. market, the federal Food and Drug Administration, better known by its

acronym, FDA, is the federal public health agency that regulates and regularly inspects the industry

practices.

Regulatory Environment

The agency protects consumers through the application of the Federal Food, Drug and Cosmetic Act,

and various public health laws.

In the international market, there are several government agencies, with their own requirements.

For example, Canada, Japan, Europe, France, and Australia have their own regulatory bodies.

The organization must meet the regulatory requirements of each country where they manufacture or

distribute their products.

What is regulated by FDA?

FDA is the federal agency responsible for ensuring that food is safe. That the medicines used by

humans and veterinarians, biological products and medical devices are safe and effective.

Also, that cosmetics and electronic products that emit radiation are safe.

The FDA also ensures that these products are represented honestly, accurately, and informatively, to the

public.

The industry operates in a Regulatory Compliance environment.

As already mentioned, the biopharmaceutical industry in the United States is regulated by a federal

government agency, the Federal Food and Drug Administration (FDA).




Globally, it operates in a regulatory compliance environment.

In addition, you must follow international quality standards, such as the international ISO standard.

Some of the well-recognized International Quality Standards in industry are those established by the

International Organization for Standardization (ISO).

.ISO Standard

ISO 9000 and 9001, version 2015, Quality Management Systems, are international standards of Quality

Management System, which can be applied to any type of organization or activities oriented to the

production of goods and services.

Organizations operating internationally, such as, pharmaceuticals or medical devices, establish their

Quality System, aligned with the requirements established by ISO to ensure that their production

processes meet internationally recognized standards. Annually, they are audited by ISO representatives,

to ensure compliance with each of the elements of the quality system.

Another similar standard is ISO 13485, which is aimed at the medical device industry.

Companies that manufacture or distribute their products internationally, outside the United States, must

comply with the requirements of the ISO standard.

Quality Systems

The quality system is an important term in these industries.

A Quality System, or Quality Management System, is a formal documented system, through procedures

and policies, established by Organizations, to ensure product safety and effectiveness, and customer

satisfaction.




The quality system consists of all the activities conducted to ensure, that a product or service, meets

the required specifications and standards.

A Quality System consists of several elements, for which your organization must have documented

procedures that establish how to implement it. Some of the elements of the quality system include:

Training and qualification of personnel,

Control the design of the product,

Documentation Control,

Purchasing Control,

Identification and traceability of the product at all stages of production,

Control and define production, and processes,

Definition and control of inspection, measurement, and testing equipment,

Process validation,

Acceptance of the product,

Control of non-conforming products,

Establish corrective and preventive actions when errors occur,

Labeling and packaging controls,

Handling, storage, distribution, and installation,

Record Control, and

Service Control.

The Elements of a Quality System for a medical device industry include:

Design control,

Corrective and preventive actions,

Production and process control,

Controls of equipment and facilities,

Control of documentation, records, and change control,

Material control,




And each element is centered around management control.

The Quality System consists of establishing a series of controls for each of the elements of the

operation.

As we can see, the Corrective and Preventive Actions (CAPA) system is one of the specific elements of

the quality system in the medical device industries. It is important to mention that other industries may

not have an element called corrective and preventive actions, but it is a requirement that is included

across the different requirements of their quality systems.

The organization establishes controls and requirements in their procedures and policies. Everything

written in the procedure is mandatory to be followed, to ensure control and compliance with each of the

elements of the Quality System.

FDA inspects, verifies the Product Manufacturer's Quality System.

The agency understands that nonconformities occur. The important thing is that the organization has

established a formal system to address these failures.

In any quality systems audit, the auditor seeks to determine what type of system the organization has to

address these failures and whether the system is effective.

The expectation is that organizations will define in a procedure what are the requirements to meet

quality objectives.

These requirements must be formally documented in the Quality System, whether in a procedure, work

instruction, policy, or any official document within the quality system.

The regulatory expectation is that these requirements will be implemented. In other words, what is

written in the procedure must be followed.




During quality audits, auditors, or inspectors look for proof, for the documented evidence that the

organization is in compliance with what the regulation establishes.

Audits and inspections goal are to determine that the organization is following its own written

procedures and is doing so in an appropriate manner.

During the audit, a sampling of the process is evaluated to ensure that the process is performed in

accordance with what is written in the procedures, and in accordance with the provisions of the

regulations or quality standards.

If the organization does not meet the requirements, does not follow its written procedures, or does not

comply with regulations, has problems, is in non-compliance with regulations, or with its Quality System.

FDA at the end of an inspection may find concerns, observations, and deviations. FDA inspectors

document them in the Form 483.

Form FDA 483, "inspection observations," is a form used by FDA to document and communicate the

concerns discovered during these inspections.

This document lists the comments made by the representative of FDA during the facility inspection.

These are inspection observations. Organizations do not want to receive a 483 during an FDA

inspection.

Organizations work throughout the year to keep their operations in compliance to avoid receiving

regulatory feedback.

Sometimes observations in the form 483 may be more critical and are escalate to a warning letter.




The Warning Letter is a letter sent to a company indicating that FDA may seek a more severe penalty if

the violations described are not corrected.

A Warning Letter is issued to promptly correct regulatory violations.

Deviations to the Regulation are interpreted by FDA as that the product is adulterated. Organization can

have serious consequences if violations of good manufacturing practices regulations occur.

Some of these consequences include:

Closure of the manufacturing operation,

Product seizure,

Poor Press Coverage,

Competitive disadvantage,

It stops the introduction of new products to the market,

Consent Decree,

Investigations,

Criminal charges,

Lawsuits,

Among others.

In future lessons we will be learning about deviations, failures, and nonconformities.




References:

The Good Manufacturing Practice (GMP - Quality System Regulation) Final Rule (Federal Register)

http://www.fda.gov/cdrh/humfac/frqsr.html http://www.fda.gov/cdrh/fr1007ap.pdf

ISO Standard

https://www.iso.org/standards.html

Quality System Regulation - Preamble References

http://www.fda.gov/cdrh/dsma/preambleref.html

Medical Device Quality Systems Manual: A Small Entity Compliance Guide

http://www.fda.gov/cdrh/dsma/gmpman.html

QSIT Inspection Handbook

http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm

http://www.fda.gov/ora/inspect_ref/igs/qsit/QSITGUIDE.PDF

GMP Guidance Documents - CDRH Office of Compliance

http://www.fda.gov/cdrh/comp/gmp.html

WHO - World Health Organization - Medical Devices

https://www.who.int/medical_devices


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