Knowra Good manufacturing practice Good manufacturing practice Good manufacturing practice (GMP) is a system of requirements for manufacturing and controlling medicines. It aims to ensure products are consistently made to defined quality standards.
Pharmaceutical quality system : A management system that directs and documents quality activities across a pharmaceutical product’s lifecycle. GMP requirements are organized and maintained through this company-wide quality framework.
Standard operating procedure : An approved written instruction describing how to perform a recurring task consistently. GMP procedures translate required practices into repeatable work instructions.
Current good manufacturing practice : U.S. regulatory requirements for manufacturing, processing, packing, or holding drugs under suitable controls. This is the U.S. regulatory framework commonly called cGMP.
Pharmaceutical inspection : A regulatory examination of facilities, records, and operations involved in making medicines. Inspections assess whether a manufacturer follows applicable GMP requirements.
Good documentation practice : Rules for creating, reviewing, recording, and retaining reliable documents and data. GMP depends on records that show what was done, by whom, and when.
Batch record : A record documenting the materials, steps, checks, and results for a specific production batch. Batch records provide traceable evidence of how each medicine batch was made.
EU GMP : The European Union’s requirements and guidance for manufacturing medicinal products. EU GMP provides the regional rules and guidance used across European medicine production.
Product recall : The removal or correction of a marketed product because it may violate requirements or pose a risk. GMP failures can lead to recalls when affected batches reach the market.
Process validation : Documented evidence that a process can consistently produce results meeting predetermined requirements. Manufacturers validate processes to demonstrate that routine production can meet specifications.
Cleanroom : A controlled environment designed to limit airborne particles and other contamination. Some medicine operations need controlled rooms to protect products from contamination.
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