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...
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...
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