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. 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

how can we help you?

Contact us at the Nucleus Consultants office nearest to you or submit a business inquiry online.

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