Quality Risk Management (QRM) is a GMP compliance requirement for Pharmaceutical organisations. The ICH Q9 guideline on Quality Risk Management (Annex 20 of the PIC/S GMP Guide) is expected to be adopted by manufacturers to ensure compliance with clauses 1.5 and 1.6 of Part I of the GMP:
We're excited to announce the first list of confirmed speakers for our Symposium to be held in Singapore on 16 - 17 March 2017: A Global Perspective on Effective Management of Risk-based GMP for Health Products.
SeerPharma is excited to be sponsoring and exhibiting at BioPharma Asia from the 21st – 23rd March at the Suntec Convention Centre in Singapore.
A multinational pharmaceutical contract manufacturer recently required the assistance of a senior pharmaceutical QA resource to assist with managing Quality and GMP issues at their manufacturing site.
Cell therapies are an emerging form of healthcare that have started to produce transformative outcomes for patients with previously refractory diseases, but they are substantially more complex than small molecule or biologic drugs and present significant challenges for researchers and companies in cell therapy translation.
SeerPharma’s Software Solutions team has been engaged to implement an electronic Quality Management System (eQMS) for a major multinational pharmaceutical company.
As part of our commitment to the local biotech sector, SeerPharma was proud to sponsor a BioMelbourne Network session on Corporate Culture and Risk earlier this year.
SeerPharma was asked to conduct a mock GMP audit of a Korean Pharmaceutical company that produces non-sterile solid dosage forms and finished products.
A number of firms have requested our expertise to provide technical and compliance audits of contract manufacturers that they currently use in Europe and Asia.
A major pharmaceutical distribution organisation engaged the services of SeerPharma (Singapore) Pte Ltd to provide a review on the compliance of its core SAP-Centric solution to the GxP Computer Systems Validation (CSV) requirements of both FDA 21 CFR Part 11 and PIC/S Guide to GMP Annex 11. There were 2 phases to this project.