SeerPharma has provided GMP Consulting assistance to support the design, commissioning, qualification, validation and licensing of a new GMP facility for an Australian pharmaceutical contract manufacturer.
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Recent Posts
QMS Help for Biotech and Medtech Start-Ups
Rational GMP Environmental Monitoring
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.
Implementing FDA, EMA and PIC/S GMP
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 Masterclass
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...
Pharmaceutical Manufacturers Association Recommends G(QC)LP Services
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.
Pharmaceutical and Medical Device QMS Solutions
The SeerPharma team has been busy implementing electronic Quality Management Systems (eQMS) for a variety of companies ranging from pharmaceutical, nutraceutical, veterinary and medical device companies.
PIC/S GMP Supplier Audits in Asia
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.