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Good Manufacturing Practice or GMP is a term that is recognized worldwide for the control and management of manufacturing and quality control of foods, pharmaceutical products, and medical Devices. GMP's are guidelines that outline the aspects of production that would affect the quality of a product. Many countries have legislated that pharmaceutical, food and medical device companies must follow GMP procedures, and have created their own GMP Guidelines that correspond with their legislation. |
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| Although there are a number of GMP guidelines, all guidelines follow a few basic principles. |
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Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. |
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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. |
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Instructions and procedures are written in clear and unambiguous language. |
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Operators are trained to carry out and document compliance to procedures. |
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Records are made, manually or electronically , 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 meets predetermined specifications and quality attributes. Deviations are documented and investigated. |
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Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. |
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The distribution of the drugs minimizes any risk to their quality. |
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A system is available for recalling any batch of drug from sale or supply. |
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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. |
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| 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 their quality program and manufacturing process, there may be many ways a company can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process. |
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In the US, the phrase "current good manufacturing practice" appears in 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351). US 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. By June 2010, the same cGMP requirements will apply to all manufacture 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 more compliance requirements than the 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.
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 US), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines to the manufacture and testing of active raw materials. |
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| GMPs are enforced in the United States by the FDA; within the European Union, GMP inspections are performed by National Regulatory Agencies. |
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GMP inspections are performed in India, Iran and Pakistan by the Ministry of Health. |
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In the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA). |
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In the Republic of Korea (South Korea) by the Korea Food and Drug Administration (KFDA). |
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In Australia by the Therapeutic Goods Administration (TGA). |
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In South Africa by the Medicines Control Council (MCC). |
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In Brazil by the National Health Surveillance Agency Brazil (ANVISA). |
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And by similar national organizations worldwide. |
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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 US 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. |
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Quality of drug substances, excipients and drug products is essential to ensure Drug product Safety. The need for GMP arose from serious quality defects of active pharmaceutical ingredients (APIs) and excipients.
Poor manufacturing practices and contamination or degradation throughout the distribution chain have been causative factors of serious quality defects. Manufacturers can overcome all these issues with a GMP implemented system.
Moreover, even companies found to comply at the time of the audit, may be tempted to adopt other practices thereafter, because of the high costs of GMP compliance and because the chance of reinspections will be remote.
To assist the marketing authorisation holders in their obligation to source only drug substances and drug products made according to GMP, it is essential that reliable information is available on the compliance status of all API producers. Stringent standards are meaningful, provided that they are correctly implemented and enforced through world-wide inspections.
GMP for drug substances and drug products can only be enforced if inspection will be mandatory and if re-inspections will take place regularly. Inspections should not be limited to the verification of GMP compliance in the facility itself. The distribution chain should also be verified. Traceability to the original manufacturer should be checked, because exchange of drug substances and drug products amongst manufacturers is a regular practice in some countries. |
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