Sentence examples for cgmp compliance from inspiring English sources

The manufacturing of plasmids under current Good Manufacturing Practices (cGMP) compliance as required by the Food and Drug Administration FDAandand European Medicines Evaluation Agency (EMEA) is crucial to obtain a product which is consistent in purity, potency, identity, efficacy and safety.

In addition, the software includes user access controls and will soon include versioning of synthesis programs to help facilitate current good manufacturing practice (cGMP) compliance.

In addition to her consulting activities, Kim is a short course instructor and organizer on topics ranging from cGMP compliance and quality issues to stability programs under sponsorship of global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, many other international training groups.

CGMP compliance of radiopharmaceuticals has been reviewed.

The CGMP compliance covers manufacturing process and facility, quality guidelines, and personnel training.

In the current study, 20 of the 21 Ig were successfully purified and released with cGMP compliance in sufficient yield to enable vaccine product manufacturing.

Here, we report the efficient automated synthesis of F-FTP (known as manually developed F-FPTP) for cGMP (current Good Manufacturing Practice) compliance and its biologic validation.

Although ELIXYS is currently supporting only preclinical PET probe production, we are in the process of implementing several software features to enable compliance with cGMP guidelines and plan to place the upgraded system into a laboratory that supports clinical production of PET probes under both 21 CFR 212 and USP 823.

Study supplies were manufactured under current Good Manufacturing Practices (cGMP) and tested in compliance with current FDA guidance for safety, purity, potency, identity and quality before release [18].

Controlled-rate freezing also provides the ability to perform the cryopreservation in properly validated equipment with documentation detailing the cryopreservation process in compliance with cGMP regulations.

The vaccine was manufactured in compliance with cGMP by Isopharma AS, Kjeller, Norway, and released for clinical use by GemVax AS, Porsgrunn, Norway.