Asia’s biopharmaceutical industry has evolved from a manufacturing destination to a goto market for clinical development and a hotbed of innovation. Asia contains some of the world’s leading pharma and biopharma markets on the planet.
TGA GMP License Assistance for a New GMP Facility
SeerPharma has commenced work assisting a firm looking to manufacture and supply multivitamin tablets to China and Australia. Our team has been engaged to help obtain a TGA GMP license by ensuring that the manufacturer has a suitable Quality Management System and will alsohelp ensure that the facility and equipment the firm plans on using is...
GMP Training for Compounding Pharmacies
Pharmacists are expected to be aware of and comply with relevant practice standards and guidelines on compounding. Despite certain exceptions, compounded medicines must meet the quality standards set out in the Therapeutic Goods Act 1989 (Cth).
Global Perspective on Effective Management of Risk-based GMP
SeerPharma in partnership with the Life Sciences Industry Group of the SingaporeManufacturing Federation held its annual Symposium for 2017 in Singapore, March 16th to 17th. The event saw over 50 delegates from across the Asia-Pacific region attend. Companies from countries such as The Philippines, Malaysia, Singapore, Australia and Sri Lanka were
There has been, is and always will be a strong focus on data in the pharmaceutical industry. When there is a manufacturing problem, data analysis can often indicate where to look for the root cause but profound process knowledge is usually required to find it.
In this article, we’ll look at 3 scenarios where pharmaceutical processing problems...
PIC/S Authorities are coming to Melbourne in April 2017 and MTPConnect - the medical technology, biotechnology and pharmaceutical (MTP) Industry Growth Centre - is going to connect the Australian sector with PIC/S event participants.
GMP Facility Design, Services and Equipment Qualification
Need expert help in the requirements for the design of GMP facilities, services and equipment in the pharmaceutical and related industries? SeerPharma has helped many companies in the Asia-Pacific region and we can help you too.
Self inspection, commonly referred to as an internal audit, is a fundamental part of implementing, maintaining and improving your Pharmaceutical Quality System. Written into the PIC/S Guide to GMP as chapter 9 due to its criticality, Pharmaceutical manufacturers must ensure their self inspection programme is effective.
INFOGRAPHIC: A snapshot of how SeerPharma has supported its clients in 2016 on matters of QA and GMP compliance.
Pharmaceutical Quality Risk Management in GMP Compliance
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 1.12 and 1.13 of Part I of the PIC/S GMP Guide: