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Good manufacturing practices (GMP) are the practices required in order to confirm to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

Good manufacturing practices, along with good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, in addition to other countries.

Good manufacturing practice guidelines provides guidance for manufacturing, testing, and quality assurance in order to ensure that drug product is safe for human consumption. Many countries have legislated that pharmaceutical and medical device manufacturer must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.

All guidelines follow a few basic principles:

Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.

Controlled environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.

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.

Practices are recommended with the goals of safeguarding the health of patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the United States, a drug may be deemed "adulterated" even though it has passed all of the specifications tests and it is found to be manufactured in a facility or condition which violates or do not comply with current good manufacturing guideline. Therefore complying with GMP is a mandatory aspect in pharmaceutical manufacturing.

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.

Guideline versions[edit]

GMPs are enforced in the United States by the U.S. Food and Drug Administration (FDA), under Section 501(B) of the 1938 Food, Drug, and Cosmetic Act (21 USCS § 351). 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] Since June 2010, a different set of cGMP requirements have applied 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 FDA's version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Singapore, Philippines, Vietnam 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.

Enforcement[edit]

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 Bangladesh by the Drug Administration (DGDA); 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] Nigeria has NAFDAC 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 (21 USCS § 374), 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.

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What is GMP?

GMP is a free library for arbitrary precision arithmetic, operating on signed integers, rational numbers, and floating-point numbers. There is no practical limit to the precision except the ones implied by the available memory in the machine GMP runs on. GMP has a rich set of functions, and the functions have a regular interface.

The main target applications for GMP are cryptography applications and research, Internet security applications, algebra systems, computational algebra research, etc.

GMP is carefully designed to be as fast as possible, both for small operands and for huge operands. The speed is achieved by using fullwords as the basic arithmetic type, by using fast algorithms, with highly optimised assembly code for the most common inner loops for a lot of CPUs, and by a general emphasis on speed.

The first GMP release was made in 1991. It is continually developed and maintained, with a new release about once a year.

Since version 6, GMP is distributed under the dual licenses, GNU LGPL v3 and GNU GPL v2.0. These licenses make the library free to use, share, and improve, and allow you to pass on the result. The GNU licenses give freedoms, but also set firm restrictions on the use with non-free programs.

GMP is part of the GNU project. For more information about the GNU project, please see the official GNU web site.

GMP's main target platforms are Unix-type systems, such as GNU/Linux, Solaris, HP-UX, Mac OS X/Darwin, BSD, AIX, etc. It also is known to work on Windows in both 32-bit and 64-bit mode.

GMP is brought to you by a team listed in the manual.

GMP is carefully developed and maintained, both technically and legally. We of course inspect and test contributed code carefully, but equally importantly we make sure we have the legal right to distribute the contributions, meaning users can safely use GMP. To achieve this, we will ask contributors to sign paperwork where they allow us to distribute their work.

GMP function categories

There are several categories of functions in GMP:

High-level signed integer arithmetic functions (mpz). There are about 150 arithmetic and logic functions in this category.

High-level rational arithmetic functions (mpq). This category consists of about 35 functions, but all signed integer arithmetic functions can be used too, by applying them to the numerator and denominator separately.

High-level floating-point arithmetic functions (mpf). This is the GMP function category to use if the C type `double' doesn't give enough precision for an application. There are about 70 functions in this category. New projects should strongly consider using the much more complete GMP extension library mpfr instead of mpf.

C++ class based interface to all of the above. (The C functions and types can of course be used directly from C++ too.)

Low-level positive-integer, hard-to-use, very low overhead functions are found in the mpn category. No memory management is performed; the caller must ensure enough space is available for the results. The set of functions is not always regular, nor is the calling interface. These functions accept input arguments in the form of pairs consisting of a pointer to the least significant word, and an integral size telling how many limbs (= words) there are in that argument. The functions in the other categories call mpn for almost all their calculations. Of these functions about 60 are public.