I worked at GSK (Barnard Castle) on two separate contracts, both were within the Operational Services Department and directly involved with the GAMP categorization and 21CFRpart11 assessments on PLC systems.
My responsibilities included the creation of prospective and retrospective full life cycle validation document packages, including URS, FDS, DQ, ERES, Requirement Traceability Matrices, IQ, OQ, PQ and Validation Summary Reports.
On my first visit I worked on the design, installation and validation of a sugar bad dispensing facility and the construction of a sterile production area for the manufacture of Agar plates (including media preparation, plate pouring, plate stacking and ink jet printer equipment). In addition, I prepared packages for Vindon stability cabinets and La Calhene glove and half suit isolators.
The second visit included extensive travel to equipment suppliers manufacturing sites to perform FAT's:
Marcehsini - Bologna, Italy - Tube filling line (Zovirax).
BHT - Munich, Germany - Sterile washing.
Fryma Kouma - Rheinfelden, Switzerland - Mixer.
Sartorius Stedim - Springfield, Missouri - Freeze Thaw Machine.
The GSK site in Barnard Castle continues to be a major player within the introduction of new equipment and processes to the GSK family, a very interesting and rewarding time within the pharmaceutical industry.
Garry Turnbull BSc.Hons.
GT Project Controls LTD.
07932 664159
Comments
Post a Comment