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发帖数: 25265 | 1 Good manufacturing practice" or "GMP" is part of a quality system covering
the manufacture and testing of pharmaceutical dosage forms or drugs and
active pharmaceutical ingredients, diagnostics, foods, pharmaceutical
products, and medical devices. GMPs are guidance 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, basic concepts of all these guidelines
remains more or less similar that is ultimate goal to safeguard the health
of the patient, producing a good quality medicine or medical devices or
active pharmaceutical products.
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.
GMP guidelines are not prescriptive instructions on how to manufacture
products. They are a series of general principles that must be observed
during manufacturing. When a company is setting up its quality program and
manufacturing process, there may be many ways it can fulfill GMP
requirements. It is the company's responsibility to determine the most
effective and efficient quality process.
Contents [hide]
1 Guideline versions
2 Enforcement
3 Other good practices
4 See also
5 References
5.1 Notes
5.2 Sources
6 External links
[edit] Guideline versions
GMPs 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.[1]
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.[2]
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.
[edit] 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 & 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, in India gmp
inspections are carried out by state FDA and these FDA report to Central
Drugs Standard Control Organization [3]and Pakistan by the Ministry of
Health;[4] 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.
[edit] 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.
[edit] See also
Corrective and preventive action (CAPA)
EudraLex
Food safety
Good Automated Manufacturing Practice (GAMP)
Packaging
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-
operation Scheme
Validation (drug manufacture)
Verification and validation
[edit] References
[edit] Notes
^ U.S. Food and Drug Administration (2007-06-22). "FDA Issues Dietary
Supplements Final Rule". Press release. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108938.htm. Retrieved 2010-06-04.
^ Pharmaceutical Press. "Rules and Guidance for Pharmaceutical Manufacturers
and Distributors - Edition: 2007" Retrieved 2010-03-01.
^ http://cdsco.nic.in/
^ http://mohfw.nic.in/
[edit] Sources
FDA page relating to GMPs
[edit] External links
FDA: Good Manufacturing Practices
Health Canada: Good Manufacturing Practices
Pharmaceutical Inspection Cooperation Scheme: GMP Guides
MHRA Good Manufacturing Guide
Therapeutic Goods Association: Good Manufacturing Practices
WHO: GMP Guidelines
EU: GMP Guidelines
Retrieved from "http://en.wikipedia.org/wiki/Good_manufacturing_practice" |
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