Chompunut Apinan

Factorytalk Co.,Ltd.,Thailand

Implementing a paperless and integrated pharma quality system

Chompunut Apinan*

Factorytalk Co.,Ltd.,Thailand

A R T I C L E I N F O

Article history:

Available online 23 November 2015

Paperless

Quality system

Compliance to the PIC/s GMP[1]standards is a mandatory and challenging requirement for ASEAN Pharmaceutical manufactures.PIC/s has at its foundation and as a very strong basis the need for a robust and wide ranging Quality Management System that will impact nearly all the departments in the organization and requires companies to setup detailed controls and records across all relevant quality aspects.To achieve the PIC/s quality objectives reliably and effciently,a comprehensively designed and implemented QMS will be based on the Quality Assurance principles and will integrate GMP,Quality Control and Quality Risk Management.The key functions required in a QMS are Document Control,Training Management Quality Event Management Quality Risk Management(QRM), Supplier Management and Audit Management.By operating a paper QMS,there are very high initial and running costs and ineffciencies to build and maintain a paper QMS,these costs rise heavily with the newer complex and holistic PIC/s requirements such as APQR and in an inspection the most common failings are related to the QMS.This talk will look to a new approach,to utilize an electronic system to meet the PIC/s requirements in a more effcient and compliant manner through the use of an integrated solution[2]that comprises all the key aspects of PIC/s GMP but with the high benefts of electronic systems and communication.The talk will include real life references and case studies.

R E F E R E N C E S

[1]PIC/S.PIC/S GMP guide.,2015.

[2]Factprutalk.Quality management system.,2015.

*E-mail address:cap@factory-talk.com.

Peer review under responsibility of Shenyang Pharmaceutical University.

http://dx.doi.org/10.1016/j.ajps.2015.10.033

1818-0876/?2016 Production and hosting by Elsevier B.V.on behalf of Shenyang Pharmaceutical University.This is an open access article under the CC BY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).