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.
A biopharmaceutical manufacturer engaged SeerPharma to provide on-going coaching to their Quality personnel and advise on improvements to help prepare for a FDA inspection.
Auspman (Western Australia Hospitals Central Pharmaceutical Manufacturing Facility) is a TGA-licensed contract manufacturer of non-commercial pharmaceuticals for hospitals, located within the Pharmacy department of Princess Margaret Hospital in Subiaco, WA.
SeerPharma’s inaugural Symposium was a great success with Operational and Quality Directors from over 30 Pharmaceutical and Medical Device / Medical Technology companies such as CSL, Patheon, Alere Medical and MSD in the crowd.
As part of our efforts to support the growth of the regional Complementary Health Product (CHP) sector, SeerPharma, with support from SPRING Singapore* and The Medicine Manufacturing Association of Singapore (TMMAS), led a delegation of Complementary Health Product SMEs from Singapore to Australia in August.
SeerPharma has provided GMP Consulting assistance to support the design, commissioning, qualification, validation and licensing of a new GMP facility for an Australian pharmaceutical contract manufacturer.
SeerPharma has been busy working with a number of start-up Biotech and Medtech companies.
Environmental monitoring (EM) of a GMP facility may be conducted for a variety of reasons. The major reasons for conducting EM are to assess the effectiveness of the cleaning program and to assess the impact of the environment on product quality.
