GMP - Good Manufacturing Practices
About GMP
"Good manufacturing practice" or
"GMP" is part of a quality
system covering the manufacture
and testing of active
pharmaceutical ingredients,
diagnostics, foods,
pharmaceutical products, and
medical devices. GMPs are
guidelines that outline the
aspects of production and
testing that can impact the
quality of a product. Many
countries have legislated that
pharmaceutical and medical
device companies must follow GMP
procedures, and have created
their own GMP guidelines that
correspond with their
legislation.
Although there are a number of
them, all guidelines follow a
few basic principles.
-
Manufacturing processes are
clearly defined and controlled.
All critical processes are
validated to ensure consistency
and compliance with
specifications.
-
Manufacturing processes are
controlled, and any changes to
the process are evaluated.
Changes that have an impact on
the quality of the drug are
validated as necessary.
-
Instructions and procedures are
written in clear and unambiguous
language. (Good Documentation
Practices)
-
Operators are trained to carry
out and document procedures.
-
Records are made, manually or by
instruments, during manufacture
that demonstrate that all the
steps required by the defined
procedures and instructions were
in fact taken and that the
quantity and quality of the drug
was as expected. Deviations are
investigated and documented.
-
Records of manufacture
(including distribution) that
enable the complete history of a
batch to be traced are retained
in a comprehensible and
accessible form.
- The
distribution of the drugs
minimizes any risk to their
quality.
- A
system is available for
recalling any batch of drug from
sale or supply.
-
Complaints about marketed drugs
are examined, the causes of
quality defects are
investigated, and appropriate
measures are taken with respect
to the defective drugs and to
prevent recurrence.
Guideline versions
GMP's are enforced in the United
States by the US FDA, under
Section 501(B) of the 1938 Food,
Drug, and Cosmetic Act
(21USC351). The regulations use
the phrase "current good
manufacturing practices" (cGMP)
to describe these guidelines.
Courts may theoretically hold
that a drug product is
adulterated even if there is no
specific regulatory requirement
that was violated as long as the
process was not performed
according to industry
standards.[citation needed] As
of June 2010, the same CGMP
requirements apply to all
manufacturers of dietary
supplements.
The World Health Organization
(WHO) version of GMP is used by
pharmaceutical regulators and
the pharmaceutical industry in
over one hundred countries
worldwide, primarily in the
developing world. The European
Union's GMP (EU-GMP) enforces
similar requirements to WHO GMP,
as does the Food and Drug
Administration's version in the
US. Similar GMPs are used in
other countries, with Australia,
Canada, Japan, Singapore and
others having highly
developed/sophisticated GMP
requirements. In the United
Kingdom, the Medicines Act
(1968) covers most aspects of
GMP in what is commonly referred
to as "The Orange Guide", which
is named so because of the color
of its cover; it is officially
known as Rules and Guidance for
Pharmaceutical Manufacturers and
Distributors.
Since the 1999 publication of
GMPs for Active Pharmaceutical
Ingredients, by the
International Conference on
Harmonization (ICH), GMPs now
apply in those countries and
trade groupings that are
signatories to ICH (the EU,
Japan and the U.S.), and applies
in other countries (e.g.,
Australia, Canada, Singapore)
which adopt ICH guidelines for
the manufacture and testing of
active raw materials.
Enforcement
Within the European Union, GMP
inspections are performed by
National Regulatory Agencies
(e.g., GMP inspections are
performed in the United Kingdom
by the Medicines and Healthcare
products Regulatory Agency (MHRA));
in the Republic of Korea (South
Korea) by the Korea Food and
Drug Administration (KFDA); in
Australia by the Therapeutical
Goods Administration (TGA); in
South Africa by the Medicines
Control Council (MCC); in Brazil
by the Agência Nacional de
Vigilância Sanitária (National
Health Surveillance Agency
Brazil) (ANVISA); in Iran, India
and Pakistan by the Ministry of
Health; and by similar national
organisations worldwide. Each of
the inspectorates carry out
routine GMP inspections to
ensure that drug products are
produced safely and correctly;
additionally, many countries
perform pre-approval inspections
(PAI) for GMP compliance prior
to the approval of a new drug
for marketing.
Regulatory agencies (including
the FDA in the U.S. and
regulatory agencies in many
European nations) are authorized
to conduct unannounced
inspections, though some are
scheduled. FDA routine domestic
inspections are usually
unannounced, but must be
conducted according to 704(A) of
the FD&C Act (21USC374), which
requires that they are performed
at a "reasonable time". Courts
have held that any time the firm
is open for business is a
reasonable time for an
inspection.
Other
good practices
Other good-practice systems,
along the same lines as GMP,
exist:
-
Good laboratory practice (GLP),
for laboratories conducting
non-clinical studies (toxicology
and pharmacology studies in
animals);
-
Good clinical practice (GCP),
for hospitals and clinicians
conducting clinical studies on
new drugs in humans;
-
Good regulatory practice (GRP),
for the management of regulatory
commitments, procedures and
documentation.
Collectively, these and other
good-practice requirements are
referred to as "GxP"
requirements, all of which
follow similar philosophies.
(Other examples include good
agriculture practices, good
guidance practices, and good
tissue practices.) In the U.S.,
medical device manufacturers
must follow what are called
"quality system regulations"
which are deliberately
harmonized with ISO
requirements, not cGMPs.
What we
do ?
Nucleus Consultants offers your
company a range of services:
- Cost-effective internal
Quality/GMP compliance audits,
litigation testimony and
vendor/supplier inspections
- Mock-FDA PAI and GMP
Inspections of biotechnology,
diagnostics, pharmaceutical and
API manufacturers
- "Due Diligence" activities
- Quality/GMP Expert Testimony
- QA and QC Systems Audits
- Supplier and Vendor audits
- Awareness and Implementation
Training
- Other GMP-related activities
To
know more about
GMP and
GMP Consultancy Services
please contact us on +91 9600001996
and mail to
info@nucleus-india.com
