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GMP - Good Manufacturing Practice

Good Manufacturing Practice (GMP) is a set of international standards that ensures products in the pharmaceutical, cosmetics, dietary supplement, and medical device sectors are manufactured consistently, safely, and to a high standard every time. In Turkey, GMP compliance is a legal requirement under the oversight of the Ministry of Health, the Turkish Medicines and Medical Devices Agency (TİTCK), and the Ministry of Agriculture. GMP compliance also serves as a powerful export tool; many export markets, particularly the EU, the U.S., and Gulf countries, require a GMP certificate as a mandatory prerequisite for product entry into their national markets.

 

A&A Consulting combines regulatory expertise with extensive technical expertise spanning from facility design to production control in its GMP consulting services. Current production conditions are compared against GMP requirements to identify priority areas for improvement. Cleanroom classification, airflow, and equipment layout are planned in accordance with standards; the effectiveness of cleaning procedures is scientifically validated. Production formulas, analysis certificates, batch records, and a deviation management system are established. Equipment suitability is documented via IQ/OQ/PQ protocols; a calibration management system is established. Sampling plans, specifications, and release procedures are implemented. GMP culture is instilled in all employees through personnel hygiene training and competency testing. The process is completed with official inspections and regulatory visits.