The GMP Know-Hows
The pharmaceutical industry requires more demanding regulations as compared to other industries; to ensure that consumers will only be exposed to high quality products. This field also mandates that any changes to the machines, processes, and the product itself must comply to strict and evolving guidelines.
GMP, or Good Manufacturing Practice is one of the most important guidelines followed in the field of pharmacy. This regulation requires manufacturers, processors, and packagers of drugs, medical devices, food, and blood to follow certain steps for the production of effective, pure, and safe products.
(See Esco Pharma Applications here: http://www.escopharma.com/application.php)
It is also referred as "cGMP", the addition of "c" stands for "current," stating that manufacturers must be up-to-date with the new technologies and systems to comply with the regulations.
GMP tackles all aspects of production - from the raw materials, the facility, to the equipment. It also involves personnel safety - encompassing training and personal hygiene. It is designed to lessen the risks, associated with any of the pharmaceutical production process, that cannot be eliminated in the final product.
Its regulations require a strict approach to manufacturing, compelling companies to minimize or eradicate possibilities of contamination and errors. Additionally, GMP addresses issues of record keeping, personnel qualifications, sanitation, cleanliness, equipment variation, process validation, and complaint handling.
Failure of compliance can result in serious consequences such as product recalls, fines, business seizure, and even jail time.
(Learn more about Quality Control here: http://www.escopharma.com/articleSubPage.php?articleId=15&pg=apt)
Since most GMP requirements are very general and open-ended, this gives manufacturers much space for deliberation on how they would interpret and implement the controls. This manner provides flexibility on how the regulations would deem fit for individual businesses’ systems.
At Esco Pharma, we provide specialist services, cGMP compliant equipment packaged and process solutions, which leads to improved protection of operators, reduction of cross-contamination and more efficient processing; thereby advancing occupational health and human healthcare.
See our GMP compliant products here: http://www.escopharma.com/products.php
References:
-
GMP Resources. (2019). Accessed last 19 Mar 2019 from https://ispe.org/initiatives/regulatory-resources/gmp
-
GMP Question and Answers. (2019). Accessed last 19 Mar 2019 from https://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/
-
What is GMP. (2019). Accessed last 19 Mar 2019 from https://ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp
Contact Us
Esco Pharma Pte. Ltd.
21 Changi South Street 1 Singapore 486777
Tel: +65 65420833
Fax: +65 65426920
Email: [email protected]
Esco Technologies, Inc.
Esco Pharma Factory
2512 Metropolitan Dr. Suite 120-B
Feasterville-Trevose, PA 19053-6738
Tel: +1 215-322-2155
Email: [email protected]
Esco GB Ltd.
Unit 2 R-Evolution @ Gateway 36
Kestrel Way, Barnsley, S70 5SZ
Tel: +44 (0) 1226 360799
Email: [email protected]
About our BRANDS
Esco Pharma provides specialist services, equipment packages, and process solutions from our core platform products leading to improved operator protection, reduction of cross contamination, and more efficient processing, thereby directly and indirectly advancing occupational health and human healthcare.
About Esco Pharma
Esco Pharma’s largest global network of localized application specialists and service offices provides faster response and local service translating into more competitive costs on maintenance, and shorter project life cycles..
Esco provides standardized platforms with inbuilt configurations without constraints on operational parameters. This enables pharmaceuticals, nutraceuticals, and cosmeceuticals to comply with international standards for occupational health and safety.
