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...
One of our senior consultants in Singapore, received the following glowing recommendation from the Sri Lanka Pharmaceutical Manufacturers' Association (SLPMA) which is a testament to the quality of our team in Singapore who continually strive to deliver exceptional service to customers in the region.
The SeerPharma team has been busy implementing electronic Quality Management Systems (eQMS) for a variety of companies ranging from nutraceutical, veterinary and medical device companies.
SeerPharma Singapore was the selected vendor and training partner to conduct introductory Good Manufacturing Practices (GMP) training for the BioProcessing Technology Institute (BTI) of Singapore.
Cynata Therapeutics Limited is an Australian stem cell and regenerative medicine company that is developing a therapeutic stem cell platform technology, Cymerus™.
Vaxxas is a Brisbane based Medical Device Company pioneering a next-generation vaccine delivery platform that enables robust immune system activation by targeting vaccine components to the abundant immunological cells immediately below the surface of the skin.