Kalbe Farma is a leading healthcare provider in Indonesia, with extensive operations throughout the South East Asian region. Its’ subsidiary PT Kalbio Global Medika (KGM) has recently opened a new 11,000 square meter factory in Indonesia, which received a Honourable Mention for the 2017 Facility of the Year Awards from ISPE.
The plant will manufacture Erythropoeitin (EPO) - a product that is crucial in dialysis and cancer medication. And will also produce other biologically derived products such as Granulocyte Colony Stimulating Factor (GCSF) and eventually Monoclonal Antibodies (MAbs) to be a leading biopharmaceutical manufacturer in the region.
PT Kalbio Global Medika Image source: ISPE
SeerPharma was engaged to deliver a two day PIC/S GMP training course to staff at KGM’s new facility in Indonesia. The request saw SeerPharma deliver training on the latest PIC/S Guide to GMP (PE 009-13) and Statistical Process Control, to help prepare staff for the eventual exporting of their
product to countries that are aligned with PIC/S.
Compliance with the latest PIC/S Guide to GMP (PE 009-13) and where there is a difference with Australian GMP. In addition PIC/S regulatory authorities are placing more emphasis on activities such as Risk Assessment and Quality by Design.
With this in mind, SeerPharma delivered a training course to help Kalbe understand the new requirements and build capability across its organisation in key areas such as management responsibility, continual improvement, knowledge/change management, outsourced activities and validation. The course helped Kalbe understand how the latest PIC/S Guide to GMP will affect their business unit as well as their business unit’s interactions with other units and the shifts in responsibilities.
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