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제약

Unlike other industries, pharmaceuticals do not allow any minor mistakes in the entire manufacturing processes including raw materials selection, manufacturing, and packing of finished productions. All pharmaceuticals make a lot of effort to maintain impeccable quality and to be certified from government agencies and partners by complying with the standards of various health related international organizations such as EU, GMP, and WHO.

LG CNS Smart Factory Solution has vast experience in designing and operating factories for many pharmaceutical companies including LG Life Sciences and Handok Pharmaceuticals. We have capabilities to satisfy customers in all aspects: production, packaging, and efficient distribution as well as compliance with international quality standards and regulations.

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Key Questions for Pharmaceutical Industry

Question 1
In the MESs for the pharmaceutical industry, the compatibility with GMP is important. How is LG CNS preparing for this?

LG CNS's MES software is in compliance with the international standards, ISA-95 and MESA guidelines, and offers 8 embedded management features for the areas of production, quality, equipment, and materials. Our pharmaceutical industry specific solution, iPharmMES, complies with pharmaceutical GMP guidelines such as cGMP, kGMP, FDA 21 CFR Part 11, and Computer System Validation (CSV). It provides not only strictly GMP management but also the MES features to support optimal manufacturing activities across the factory.

Question 2
You mentioned Global GMP and FDA 21 CFR Part 11. How does it support them specifically?

LG CNS iPharmMES provides templates such as production order, packaging order, weighing logs, yield rate logs, production order and logs, machine operation and cleaning log, and a man-hour log which complies with Global GMP and FDA 21 CFR Part 11.

Question 3
When there is a problem in manufacturing a medical substance, it could have devastating consequences for a person's life under worst case scenarios. Hence, material or process management are very important with pharmaceutical companies. How do you manage this?

We provide features to print and attach barcodes on every material to track their movement and prevent incorrect selection.

Question 4
What are the advantages of deploying LG CNS's solution?

LGCNS iPharmMES helps companies in complying with regulations such as GMP, Computer System Validation (CSV), and FDA 21 CFR Part 11, and streamlining their processes. Companies can optimize process operations to improve productivity, quality, equipment efficiency, and non-adjusted ratio using iPharmMES. It can also support optimal manufacturing activities and on-time delivery.