Prime Validation Services (PVS Ltd) was founded by David Clarkson in 2007. With over 25 years of validation experience in the life science industries, David started the company after previous working within validation roles at Sanofi Aventis and GSK - when validation was in its infancy.

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PVS has gained much experience in many areas of the pharma and medical device industries, successfully qualifying:

 

• Equipment (including manufacturing, packaging, inspection and laboratory equipment).

• Facilities (including cold stores, cold chain, warehouses and clean rooms).

• Utilities (including water systems, HVAC, nitrogen, compressed air and clean steam).

• Products and devices (including API's - liquids, powders, ointments, creams, inhalation products, cartridges and medical devices).

• Sterilisation/ Cleaning (including SIP of filling machines/ filters/ vessels and manual cleaning qualification).

• Automated equipment/ systems/ software.

 

The experience which PVS has gained incorporates the preparation, execution and reporting of commissioning, VMPs, VMRs, FATS, SATS, DQ (and Impact Assessments, VDSs, RTMs, URSs), IQ, OQ, PQ, PV & Re-qualification documentation, to a very high quality standard, and the execution and planning of the qualification exercises. A very thorough knowledge of the validation life cycle has been gained over many years working within company validation systems, templates and procedures.

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PVS have a clear and concise understanding of quality systems, engineering guides and compliance systems such as ISPE baseline guides, CGMP, CGVP, ICH Q7A, GAMP5, ISO9001, ISO13485, 21 CFR Part 820 and 21 CFR Parts 210, 211 & 11. The company is also skilled in the preparation and review of additional documentation and activities including SOPs, deviation reports, CAPA reports, periodic reviews, design reviews, non-conformances, route cause analysis, change controls, URSs, FMEA, risk assessments and continuous process improvement evaluations/ activities such as Lean Sigma. PVS have also successfully participated in supplier audit visits, site FDA / MHRA audits and validation archiving.

 

PVS have gained much experience conducting commissioning, factory acceptance and validation work overseas (including France, Germany, Italy and Ireland). The company prides itself on good communication and interpersonal skills gained through much experience working in cross functional teams with a thorough grasp of the role and requirements of production, engineering, maintenance, quality and laboratory personnel within the validation life cycle. 

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PVS maintain their current expertise and regulatory updates through the following activities:-

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• On site project work dealing with current projects and regulatory compliance issues. Current feedback and benchmarking.

• Membership of the International Society of Pharmaceutical Engineers (ISPE) and receiving all current baseline guides and reports.

• Attendance at training courses, expanding knowledge and exhibitions for updates and guidance.

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Testimonials:

 

‘PVS showed a capability to be sensitive to the needs of the team and work very hard as and when required.’

Brian Collins, Validation Manager, Wyeth Pharmaceuticals, Havant

 

‘PVS was highly conscientious in the work with an excellent attention to detail. I am happy to recommend.’

Karen Stevenson, Validation Manager, Patheon, Swindon

 

‘PVS showed good aptitude to the tasks in hand utilising skills obviously gleaned from previous experience. There was good communication throughout the project’.

Paul Greig, Validation Lead, McFarlan Smith Ltd, Edinburgh