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.
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.
Pharmaceuticals. 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.
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?
Medical Devices. A medical device is an object, device or product used for diagnostic or therapeutic purposes.
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. Biological products are derived from living material, for example, microorganisms, humans, plant, or animal tissue.
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.
Regulatory Environment
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.
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:
The Elements of a Quality System for a medical device industry include:
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:
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
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
ISO Standard
https://www.iso.org/standards.html
WHO - World Health Organization - Medical Devices
https://www.who.int/medical_devices
