Laboratory Services
MEDVACON Can Assist With The
Following Laboratory Projects:
- Project Management Training Lab audits/ FDA inspection readiness services
- Facility and utility commissioning and qualification: evaluation of architectural and PID
- GLP and GMP facility design and implementation
- Instrument qualification and method validation
- Computer System Validation (IQ/OQ/PQ)
- Process Validation
- CLIA / CAP Compliance
- Process optimization through 5S and Lean techniques
- Technology Transfers (if moving from one of your current labs)
- Oversight of HVAC, water, air, and electrical systems
- Project Management (particularly during the bid process: to ensure alignment with specs, documentation compliance; collaborate with the GC, subcontractors, etc.)
- GLP / GxP Training
- Staffing/ Talent Acquisition (if hiring for your facility)
Example Projects:
Laboratory Equipment Qualification
MEDVACON was engaged by an API manufacturer to conduct laboratory equipment qualification and system suitability testing of lab and manufacturing equipment. The objective and output of the assessment was system suitability and equipment qualification documentation to support the validated state of the lab equipment. The onsite assessment and work was conducted by a MEDVACON Sr. Validation Consultant. Equipment covered included items such as: UV-vis, ICP Spectrometer, Waters HPLC’s, Malvern particle sizer, Ph meters, Refractometer, Density meter, Chlorodation titrator. Ultimately the work was completed and the client continued to engage MEDVACON for support.
Pharmaceutical Empower and Laboratory Equipment Qualification
MEDVACON was engaged by a pharmaceutical manufacturing company to conduct the computer system validation and equipment qualification related the implementation of Waters Empower 3 Chromatography Software system and equipment into the laboratories. MEDVACON developed the validation plan, all protocols, additional documentation around system operation, and executed all the validation documents for the Empower software as well as the hardware Lace boxes. The project resulted in the successful validation of the system and MEDVACON was retained by the client to conduct additional work at the site.
EMA Inspection Readiness – Pharmaceutical Contract Testing Laboratory
MEDVACON was engaged by a client that provides contract testing to the pharmaceutical industry to provide EMA Inspection Readiness services. To assist the client in adequately preparing for the audit as well as continuing to support external customers, MEDVACON provided a senior quality expert and operational SME’s to support the multiple ongoing activities. The MEDVACON team’s readiness activities included: supporting external client interactions, supporting ongoing internal activities necessary to maintain GMP status, interim Project Management of ongoing QA, EQ and CSV initiatives; as well as preparatory activities specifically in support of the upcoming EMA audit of the site. The audit outcome was highly successful, and recognized by the Firm’s leadership; and the client continued to engage MEDVACON in additional compliance activities.
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