Drug Development & Regulation

Good Manufacturing Practice GMP

TRİyi İmalat Uygulamaları
Also known as:cGMP · Current Good Manufacturing Practice

The part of pharmaceutical quality assurance that ensures medicines are consistently manufactured and controlled to the quality standards appropriate to their intended use and required by the marketing authorization.

In depth

GMP covers the pharmaceutical quality system, qualified personnel, premises and equipment, documentation, process and cleaning validation, quality control testing, handling of deviations and complaints, and formal certification and release of each batch. Requirements are harmonized internationally through WHO, EU and PIC/S guides, with ICH Q7 covering active substances.

National authorities, such as TİTCK in Turkey, inspect and certify manufacturing sites. GMP is part of the wider 'GxP' framework alongside Good Laboratory, Good Clinical and Good Distribution Practice.

Clinical pearl

Manufacturing quality failures lead to recalls, as with the nitrosamine impurities found in some sartan products; pharmacies should act promptly on recall notices and quarantine affected batches.

TRIn Turkish

İyi İmalat Uygulamaları

İlaçların, kullanım amaçlarına uygun ve ruhsatın gerektirdiği kalite standartlarında tutarlı biçimde üretilmesini ve kontrol edilmesini güvence altına alan farmasötik kalite güvencesi bileşenidir.

GMP; farmasötik kalite sistemini, yetkin personeli, tesis ve ekipmanı, dokümantasyonu, proses ve temizlik validasyonunu, kalite kontrol testlerini, sapma ve şikâyetlerin yönetimini ve her serinin resmî olarak onaylanıp piyasaya serbest bırakılmasını kapsar. Gereklilikler DSÖ, AB ve PIC/S kılavuzlarıyla uluslararası düzeyde uyumlaştırılmıştır; etkin maddeler için ICH Q7 kılavuzu esas alınır.

Üretim tesisleri, Türkiye'de TİTCK gibi ulusal otoriteler tarafından denetlenir ve belgelendirilir. GMP; İyi Laboratuvar, İyi Klinik ve İyi Dağıtım Uygulamalarıyla birlikte daha geniş 'GxP' çerçevesinin parçasıdır.

Üretim kalitesindeki hatalar, bazı sartan ürünlerinde saptanan nitrozamin safsızlıklarında olduğu gibi geri çekmelere yol açar; eczaneler geri çekme duyurularına hızla uymalı ve etkilenen serileri karantinaya almalıdır.

Diğer adları:İyi Üretim Uygulamaları
Updated 24.09.2026 0 views Educational reference — verify against current sources before clinical use.

Read next

Good Clinical Practiceİyi Klinik Uygulamalar

An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials, ensuring that participants' rights, safety and well-being are protected and that trial data are credible.

 Active Pharmaceutical IngredientEtkin Madde

The substance in a medicinal product that is responsible for its pharmacological activity, as distinct from the excipients; in manufacturing terms it is the drug substance produced under GMP.

 ExcipientYardımcı Madde

Any constituent of a medicinal product other than the active substance, added to enable manufacture, maintain stability, control release, improve acceptability or aid administration.

 Marketing AuthorizationRuhsat

The license granted by a competent regulatory authority that allows a medicinal product to be placed on the market, based on assessment of its quality, safety and efficacy for defined indications and conditions of use.

 Shelf LifeRaf Ömrü

The period during which a medicinal product, stored under the specified conditions, is expected to remain within its approved quality specifications for identity, strength, purity and performance.

 GenotoxicityGenotoksisite

The property of a chemical or physical agent to damage genetic material, causing gene mutations, structural chromosome aberrations or changes in chromosome number that may lead to cancer or heritable defects.