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...
Major pharmaceutical companies in the Asian region requested assistance with GMP supplier audits .
It is imperative that Pharmaceutical companies have a good handle on how to perform Product Quality Reviews (PQR). In fact, effective PQR’s are necessary in demonstrating GMP compliance to regulators such as the TGA and FDA (Annual Product Review).
When handling a pharmaceutical or medical device, it is imperative in the eyes of the regulator, such as the TGA or FDA, that people within your organisation are assigned appropriate roles and responsibilities. One of the most important roles is that of the Authorised Person, who is responsible for authorising steps of the manufacturing process,...
As a manufacturer or sponsor of a pharmaceutical and/or medical device, you need to ensure control over component and product quality, as well compliance with legal and customer requirements. Establishing and maintaining a supplier quality assurance program can be a challenge, with regulatory requirements and supply chain complexity continuing to...
Your quality systems and procedures are in place, however no matter how much you try, people still don’t fully comply with them. These deviations and subsequent investigations lead to lost productivity. Typically you identify “human error” as the root cause and your corrective action is to train your team.
We’re proud to announce that Andrew Giles will be joining SeerPharma as a Senior Consultant based out of our Melbourne office from 21st of March 2016.
The Quality / GMP stream hosted by ISPE at this year’s ARCS congress was a great opportunity to explore the latest issues and trends. Feedback and questions raised during the Quality / GMP sessions identified three current areas of interest to many involved in this area of work. Namely the approach and use of Quality Management Systems, Validation...
Are you a manufacturer working in a regulated environment? Wondering if there is any value on bringing in a GMP consultant? Start with our 5 best tips on choosing and securing a budget for GMP consulting support for your business.
