SeerPharma Singapore in collaboration with SPRING Singapore rolled out a series of GxP Consultancy and Training modules for the manufacturers of traditional medicines.
SPRING Singapore is an agency under the Ministry of Trade and Industry responsible for helping Singapore enterprises (Small and Medium Enterprises) grow. Under this initiative, the participants from this industry were able to obtain funding from SPRING under the CDG (Capability Development Grant) to help the members upgrade their knowledge and understanding of GxP regulatory requirements through consultancy and public training.
In order to provide the industry with more relevant training topics, the team from SeerPharma met up with the Audit and Licensing Division of the Health Sciences Authority (HSA) to discuss the needs of the industry and the common deficiencies faced.
A total of 10 companies signed up for the Grant, which offered up to 70% funding for a value of up to SGD$42000 per company.
This project is in its final leg, after starting in June 2016, and so far more than 12 training modules have been run. The modules included many case studies and workshops (some of which were developed from common observations our consultants noted while conducting consultancy with these companies) to help the participants understand the concepts better. Modules address topics including Change Control, Contamination Control, Good Documentation Practices, Validation, Process and Cleaning Validation, Risk Assessment, Failure Investigation, Root Cause Analysis and CAPA.
Working closely with engaged companies, our consultants reviewed their audit findings, documentation and processes. One company underwent a US FDA audit smoothly with just a few minor observations following a series of consultancy sessions by SeerPharma under this programme.
As most of these companies are very small operations, the CDG was really helpful for these companies to upgrade their processes, quality systems, understanding and knowledge to enable them to manufacture their products in compliance with PIC/S GMP for both the local and export markets.
Due to the success of this project, the Association and SeerPharma are in discussion with SPRING to approve a second project under a new phase. The objective of the second project is to reach out to the manufacturers who did not sign up the first time as well as to bring the current participants to a higher level of compliance.
Contact us to explore how SeerPharma GxP Consultancy and Training could help your traditional chinese medicine manufacturing operations.
This post comes from our July 2017 Journal. You may also be interested in:
- Singapore Complementary Medicine GMP Study Tour of Australia
- GMP Training for Bioprocessing Technology Institute (BTI) Singapore
