Sie sind auf Seite 1von 4

Good manufacturing process (GMP) guidelines are essential to ensure drugs are produced to a consistently high quality.

GMP guidelines should be implemented at all stages of the manufacturing process to eliminate the possibility of risks, that may not be detected during clinical trials. If GMP guidelines are not correctly implemented, there is a risk that poor quality and substandard pharmaceuticals could make it on to the market and potentially cause damage to the health of members of the public. Poor quality medicines also cause governments and individuals to waste their money. The World Health Organisation (WHO) is a strong supporter of stringent GMP guidelines, without which it claims it would be impossible to ensure that all drugs have been manufactured to the same standards. WHO GMP guidelines The WHO identifies a number of possible risks which can occur when GMP guidelines for pharmaceuticals are not correctly implemented. These include the contamination of manufactured products, damage to public health which may lead to fatalities, and even incorrect labelling which could lead to patients receiving the wrong medication. If GMP guidelines for APIs are not followed, there is also a risk that the incorrect levels of an active ingredient could be present in medicines, causing treatment to become ineffective or creating adverse effects. Systems must also be in place to demonstrate that GMP guidelines for pharmaceuticals and GMP guidelines for API have been properly followed. According to the WHO, the implementation of GMP guidelines is "an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals." The WHO recommended GMP guidelines are adopted in a number of countries, while a number have harmonised their guidelines including the European Union, the Association of South-East Asian Nations and the Pharmaceutical Inspection Convention. GMP Guidelines FDA The United States Food and Drug Agency (FDA) takes the view that GMP guidelines for pharmaceuticals "affect every American". Current GMP (cGMP) guidelines, as defined by the FDA, require companies to use the most up-to-date systems and practices in order to comply with the regulations. "Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups and

errors ten or twenty years ago may be less than adequate by today's standards," the FDA explains. However, the FDA stresses that its GMP guidelines for pharmaceuticals, which are flexible to allow each manufacturer to create the most appropriate controls for its processes, are the minimum standards that the pharmaceutical industry should meet. To ensure that regulations are followed correctly, the FDA sends trained professionals to inspect facilities. The agency also takes reports from members of the public and industry to identify sites for investigation or inspection; however the FDA stresses that "most companies that are inspected are found to be fully compliant with the cGMP regulations". Guidance on regulations can be gained through the Federal Register and the FDA website. The organisation supplies information on cGMP guidelines through FDA Small Business Representatives and District Offices, which are located throughout the US, and through the Center for Drug Evaluation and Research, Office of Compliance, Division of Manufacturing and Product Quality. The F

Good manufacturing

practice
From Wikipedia, the free encyclopedia
(Redirected from Current good manufacturing practice)

"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including 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 of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S. a drug may be deemed adulterated if it passes all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guidelines. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing. 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]

y y y y y o o y

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, a different set of 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.
DA also operates a number of outreach programmes on cGMP guidelines.

Das könnte Ihnen auch gefallen