Within the pharmaceutical industry the “GxP” definition of “validation” is often quoted as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes” (FDA (1987), General Principles of Process Validation).
GXP.Management.Services has extensive experience within the pharmaceutical industry providing services for a variety of job roles and has over 20 years experience of laboratory instrument and computer system validation to regulatory standards with many past projects successfully undergoing FDA & MHRA regulatory audits.
Working with many global blue chip pharmaceutical companies, including GlaxoSmithKline, Sanofi Aventis and Bristol Myers Squibb as well as smaller contract laboratory testing organisations, this valuable experience is offered DIRECT to the Client or through their approved contract service supplier.
Whether your pharmaceutical or biotech business requires a full Project Management / Computer System Validation Service (CSV) or simply another contract Project Manager, Process or CSV Engineer and/or Chartered Chemist to slot into your organisation and assist your business to fulfil project deadlines, GXP Management Services is fully equipped to meet your business requirements.
Typical Project Management and Validation Services include:
- Regulatory compliance Gap and Risk assessments (MHRA Orange Guide & FDA 21 CFR parts 210/211)
- New Data Integrity (ALCOA+) and 21 CFR part 11 assessments and remediation advice
- Management of the installation, implementation and validation of:
- Chromatography Data Systems (CDS), (e.g. Empower and Cerity)
- Laboratory Information Management Systems (LIMS), (e.g. LABWare, SampleManager).
- Distributed Control System software (e.g. Emerson DeltaV, Siemens PCS 7)
- Network infrastructure validation.
- Commissioning and qualification of facilities and services etc.
- Installation and validation of laboratory analytical equipment:
- Chromatography instruments: HPLC / GC / GC-MS / Ion chromatography
- Spectrophotometers: UV-Vis, AA, ICP
- Particle sizers (Sympatec, Malvern)
- NMR instruments
- XRPD (Panalytical)
- TOC Analysers
- Validation of manufacturing equipment:
- Tablet presses, coaters
- Product driers
- Stability rooms/cabinets
- Fridges & freezers