A set of guidelines that addresses the principles required for the proper
design, maintenance, and control of operations or facilities involved in the
manufacturing and care of products intended for human use and regulated by the
FDA.
The current Good Manufacturing Practice (GMP) requirements set forth in the
Quality System (QS) regulation are promulgated under section 520 of the Food,
Drug and Cosmetic (FD&C) Act. They require that domestic or foreign
manufacturers have a quality system for the design, manufacture, packaging,
labeling, storage, installation, and servicing of finished medical devices
intended for commercial distribution in the United States. (EFFECTIVE DATE: Aug.
8, 1993)
GMP refers to the Good Manufacturing Practice Regulations promulgated by the
US Food and Drug Administration under the authority of the
Federal Food, Drug, and Cosmetic Act (See
Chapter IV for
food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These
regulations, which have the force of law, require that manufacturers,
processors, and packagers of drugs, medical devices, some food, and blood take
proactive steps to ensure that their products are safe, pure, and effective. GMP
regulations require a quality approach to manufacturing, enabling companies to
minimize or eliminate instances of contamination, mix-ups,
and errors. This in turn, protects the consumer from purchasing a product which
is not effective or even dangerous. Failure of firms to comply with GMP
regulations can result in very serious consequences including recall, seizure,
fines, and jail time.
GMP regulations address issues including recordkeeping, personnel
qualifications, sanitation, cleanliness, equipment verification, process
validation, and complaint handling. Most GMP requirements are very general and
open-ended, allowing each manufacturer to decide individually how to best
implement the necessary controls. This provides much flexibility, but also
requires that the manufacturer interpret the requirements in a manner which
makes sense for each individual business. GMP is also sometimes referred to as
"cGMP". The "c" stands for "current," reminding manufacturers that they must
employ technologies and systems which are up-to-date in order to comply with the
regulation. Systems and equipment used to prevent contamination, mix-ups,
and errors, which may have been "top-of-the-line" 20 years ago, may be less than
adequate by today's standards.
GMP is a good business tool which will help to refine both compliance and
performance at your company. GMP requirements are largely common sense practices
which will help your company better itself as it moves toward a quality approach
using continuous improvement.
Steps of achieving GMP:
First, set standards of performance. These include GMP regulations and
other standards which are necessary for your company. Then, train to those
standards. All departments in the company should be trained (to varying
degrees) on GMP and other standards. There are
four types of employees which are especially critical to train: top
management, managers and supervisors, operators and technicians, and support
staff. Because training is such an important part of maintaining a GMP
Lifestyle, the focus
should lay heavily on training.
The next step in the GMP Lifestyle is to reinforce what was learned in
training. This falls on the managers and supervisors in a plant. Therefore,
it is important that managers and supervisors be involved in training, so
that they can support it through reinforcement. The same four job categories
are listed as being the most critical in promoting and receiving
reinforcement.
The third stage is to audit to ensure that your efforts have provided
adequate controls by auditing. Audits fall in the following three
categories:
personal, whereby every individual does a self-check to make sure
that he/she is complying with all appropriate standards
internal audit, which should be performed by the quality assurance
department as required by GMP
external audits, which can consist of an FDA audit, a consultant
checking your compliance status, or you performing a supplier audit.
Finally, the results of audits will help you to know if you need to
modify your standards of performance. Of course, no procedures should be
changed without appropriate change control and approval from quality
assurance. The glue that sticks the whole process together is commitment.
Commitment to GMP and quality is critical at all levels of the organization,
starting with top management. If you foster commitment
and use this process, you will help you make GMP a
lifestyle, not just a regulation in your company. You will then improve the
overall performance of your workforce, as well as your FDA compliance.
CTS can offer assistance with all of these steps with
training, SOP generation, audit preparation, and quality management
consulting.
A standard operating procedure is a set of instructions having the force of a
directive, covering those features of operations that lend themselves to a
definite or standardized procedure without loss of effectiveness. Every good
quality system is based on its standard operating procedures (SOPs). In clinical
research, SOPs are defined by the
International Conference on
Harmonisation (ICH) as "detailed, written instructions to achieve uniformity
of the performance of a specific function". SOPs are necessary for a clinical
research organization—whether it concerns a pharmaceutical company, a sponsor, a
contract research organization, an investigator site, an Ethics Committee or any
other party involved in clinical research—to achieve maximum safety and
efficiency of the performed clinical research operations. It is therefore a must
that all people and sites involved in clinical studies (both at the sponsor and
at the investigative sites) have appropriate SOPs in place in order to conduct
clinical research and to assure compliance with the current regulations. The ICH
GCP (good clinical practice) Step 5 Guideline (Section 3.2.2) also suggests that
an Institutional Review Board (IRB) have its own SOPs or written standard
procedures. This itself proves that presence of SOPs are an integral part of the
clinical trial at all levels. The presence of these quality documents is
essential when inspections take place since the most frequent reported
deficiencies during inspections are the lack of written SOPs and/or the failure
to adhere to them. The risk of GCP non-compliance is high at organizations with
a poor availability of clinical research specific SOPs and also if at all they
are available the staff or the people for whom they were written are not either
aware of them or their need. It therefore becomes very important for the staff
to train them on these SOPs so that they are actually aware of why and how SOPs
can play important role in fulfilling the ICH and other regulatory requirements.
Title 21 CFR Part 11 of the Code of Federal Regulations deals with the FDA
guidelines on electronic records and electronic signatures in the United States.
Part 11 as it is commonly called, defines the criteria under which electronic
records and electronic signatures are considered to be trustworthy, reliable and
equivalent to paper records. Practically speaking, Part 11 requires drug makers,
medical device manufacturers, biotech companies, biologics developers, and other
FDA-regulated industries (not including food manufacturers) to implement
controls, including audits, validation systems, and documentation for software
and systems involved in processing many forms of data as part of business
operations and product development.
This table describes
how the the custom monitoring application meets the requirements of the
regulation. If you would like more information on the regulations and how CTS
helps you meet them, please feel free to call or submit your questions via the
CONTACT US form.
Joint Commission does not specifically require temperature logs for
refrigerators and freezers used for medication storage. Standard MM.2.20
requires that medications be stored under necessary conditions to ensure
stability. EC.6.10 additionally requires that you describe and implement
processes to maintain and monitor equipment performance. If your organization
chooses to use temperature monitoring to achieve this, the monitoring method
must track temperature in an ongoing fashion to indicate whether or not internal
temperature has deviated from the required ranges for all drugs stored. In
addition, the organization should have a defined process outlining disposition
of medication from a refrigerator or freezer which has deviated from the
recommended temperature range.
You first complete an order form online or by fax.
A temperature logger (about the size of a credit card and 3/8 inch
thick) and an instruction sheet will be sent to you via common carrier (UPS,
FEDEX, ETC.).
Clear and concise written instructions will walk you through activation
of the logger and placement of the logger in the unit.
The logger records temperature every 5 minutes over the predetermined
time period (usually 14 days, but you may request a shorter period). At the
end of 14 days, the logger will automatically stop recording.
Upon completion of the predetermined data collection period, you remove
the logger and return it to CTS in the pre-addressed, pre-stamped envelope.
We at CTS will download the data from the logger, analyze the data, and
provide you with a detailed written assessment report. Your
report will also be available if you wish to download on the internet (generally after
7 days).
