(Company Confidential) Quality assurance requirements, like those in GMPs,
are not peculiar to the United States. Many other The good news is that the majority of GMP
countries have similar requirements for medical requirements can be met by simply exercising
Good Manufacturing Practices products. In addition, businesses across all good work habits. Being aware of your
procedures, producing legible records, and
(GMPs) industries can choose to adopt voluntary standards
keeping an organized and clean work
that are like GMPs, such as ISO 9000.
This brochure is provided to you as an environment are all key elements.
employee of (company confidential) so that GMPs and the (company confidential) Quality
System GMPs and Compliance
you are introduced to the quality system
requirements the Food and Drug GMP requirements are specific in what a People who are internal and external to
Administration (FDA) prescribes for the manufacturer has to accomplish in business practice. (company confidential) will perform periodic
medical device industry, called Good However, the manufacturer decides how the checks to ensure that requirements are being
Manufacturing Practices (GMPs). requirements are met. met.
These requirements have the force and effect Part of demonstrating how the requirements are met These checks, called audits, may be
of law. Please read this material carefully and is through the development of written documentation. performed by an Alpha Industries employee, a
discuss any questions you have with your vendor, a consulting firm, or by FDA.
manager. Procedures are written to reflect who does what, and
when. They demonstrate that the manufacturer plans Audits help to ensure that companies continue
What are GMPs? and controls the processes affecting product quality. to meet requirements and identify areas where
Additionally, procedures are an important way of they can improve. Deficiencies and
In 1976, the United States Congress added improvements are made through a corrective
the medical device amendments to the communicating job responsibilities to employees.
and preventive action procedure.
Federal Food, Drug, and Cosmetic Act. Records are the result of following procedures, and
Congress also authorized the FDA to establish are evidence that important work activities take place. Corrective and preventive action isn't only the
and enforce GMP regulations. Completed forms, correspondence with customers result of audits, however. Employees should
and vendors, and statements of business transaction be diligent in reporting problems or potential
The requirements are directed toward quality problems that may affect product quality.
assurance and govern how manufacturers are examples of records that must be maintained so
design, manufacture, package, label, store, that the quality system can be effectively reviewed. The Ultimate Goal: Consumer Safety
install, and service devices intended for Manufacturers are also required to provide the entire
human use. In addition to performing regular audits of
business organization with goals related to quality. manufacturers, the FDA monitors public safety
The GMP regulation is available for anyone to These are documented and communicated as the through Medical Device Reporting.
read in the Code of Federal Regulations (Part Quality Policy and quality objectives.
820 of Title 21). The information is also Reports come to the FDA on a voluntary basis
posted for the public on the FDA web site Quality Policy from health care professionals and patients
(http://www.accessdata.fda.gov/scripts/cdrh/cf who have first hand knowledge of a device
docs/cfcfr/CFRSearch.cfm?CFRPart=820&sho (company confidential) will provide safe and malfunction or adverse patient event.
wFR=1). effective medical products to our customers.
Manufacturers are required to report device
Why are GMPs important? malfunctions that may be associated with
Who is responsible for GMP requirements? patient injury.
GMPs are viewed as an essential tool in public All employees of medical device manufacturers are
safety. They require manufacturers to plan (company confidential) has a published
responsible for ensuring that GMP requirements are Medical Device Reporting procedure. Any
and implement business practices to ensure met.
medical devices meet specifications, and the employee who becomes aware of a device
public is not harmed due to unanticipated FDA regulations are unique in that they apply not only malfunction should report it to management
events. to businesses, but also to individual employees. If immediately.
you are employed in the medical device industry, you
are personally accountable to the FDA.
GMP Brochure, Rev. 001