SERVICES PROVIDED:
Project Lead / Senior Equipment Commissioning/Validation Engineer / GMP-Technical Quality Reviewer
(5-6 people and 4 packaging lines)
(FDA Compliance Contract)
07/01 - 10/02
Large Scale Capital Packaging Commissioning/Revalidation/Validation Project:
- Quality / GMP / technical review, project management, such as project tracking, cost projections, meeting project deadlines and real time estimates to complete given project tasks.
- Facilitate and participate with multidisciplinary teams, consisting of QA, Packaging, Engineering and other management personnel to discuss implementation and methodologies to ensure compliance.
- Developed Equipment Commissioning Reports, Engineering Studies, IQ, OQ, Component Specific Operational Qualifications (CSOQ) and PQ’s IAW Schering-Plough SOP's, cGMP and FDA guidelines (21 CFR Part 210/211) for K2 & K10 packaging lines.
- Ointment and solid dose products filled, packaged and qualified included: A & D Ointment, Claritin, Clarinex, Imdur, Di-Gel, K-Dur, and Proventil.
- Packaging equipment includes: CAM M90 & M92 Blister Thermoformers, a CAM HV-1 Blister Cartoner, a CAM NC/61Blister Counter / Stacker, an UHLMANN UPS4 Blister Thermoformer, a RESINA UN30 Capper and an ENERCON Cap Inspection System, semi automatic and automatic oinment filling machines to name a few.
- Coordinated/executed/qualified/validated/tested packaging lines using newly developed engineering studies & qualification protocols. Protocol executions included black box testing.
- Participated in weekly Quality Review Board (QRB) meetings
Validation Services
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Semi Automatic & Fully Automatic Oinment Filling machines with production outputs of 25 tubes/minute to 120 tubes/minute (A&D ointment ).
