INFOGRAPHIC: A snapshot of how SeerPharma has supported its clients in 2017 on matters of QA and GMP compliance.
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.
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.
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:
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.
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.
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...
