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.
SeerPharma (Singapore) was engaged by a company in Singapore to help implement cGMP for a new clinical trial packaging facility and obtain international certification of conformance to FDA, EMA and PIC/S GMP.
GMP Data Integrity is an issue that a number of our clients have approached us about recently. The concept of Data Integrity has been around for quite some time, with the TGA introducing the concept of electronic records in to the previous Australian code of GMP back in 1990, while the FDA made 21 CFR Part 11 Electronic records and signatures...
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