Vastern Consultants has worked on a variety of different projects, some of which are described below. Please feel free to contact us for further details or references.

Interim QA Business Manager/ Responsible Person (RP)

For an international pharmaceutical company dedicated to the supply and distribution of vaccines

• Ensure compliance with the company's Wholesale Dealer's Licence (WL), Good Distribution Practice (GDP) and Corporate requirements
• Perform local batch release of product to market (MIF sign off)
• Manage the QA team
• Audit of third party pharmaceutical cold chain storage and distribution agent 

Audits

• Pre-MHRA mock audit for a biologics Contract Manufacturing Organisation (CMO)
• Series of vendor evaluation audits (covering analytical method development, stability, IMP manufacture, packaging and labelling, QC testing, QP batch certification, storage and distribution) on behalf of a multinational Contract Research Organisation (CRO)
• GMP audits of external laboratories and contract manufacturers
• Specialist clinical trials packaging and labelling facility
• IMP manufacturer (sterile lyophilized solid for reconstitution for infusion) 

Interim QA Assistance

Providing assistance to the Head of QA of a biotechnology company focused on the development and commercialisation of biological treatments for cancer and the prevention of infectious diseases:

• Reviewing and updating existing QA procedures (complaints, recall, OOS results)
• Drafting new procedures (Technical/ Quality Agreements, technology transfer, laboratory investigations)
• Technical review of Development protocols and reports
• External audit of contract laboratory 

QMS Design and Implementation Project

For a small, privately funded pharmaceutical company based in France, focussed on the discovery, development and rapid progression to market of novel antibacterial and antifungal agents to treat severe and difficult to treat bacterial and fungal infections. The client has a broad portfolio of development candidates, discovery programmes and IP, with several Clinical and one Preclinical candidates.

QP Batch Certification

Certifying batches of Investigational Medicinal Product(s) in accordance with EU Directive 2001/20/EC for a leading developer, listed on the London Stock Exchange, of regenerative medicinal products to restore skin and hair; for use in Phase III trials in the EU and US.

Training Seminar

Presentation introducing the concept of pharmaceutical quality assurance to the Development team of a small privately funded Swiss company that is developing small molecule drugs based on genetic chemistry.

Training and advising the Director of Regulatory Affairs and Quality Assurance on Quality Management System (QMS) design.

'Virtual' Quality Assistance

For a small Drug Development team in a well-known fragment-based drug discovery company running Phase I/ II clinical trials in the UK and US:

• Providing independent oversight of the client’s Quality Management System (QMS)
• Providing professional assistance and advice related to all quality incidents raised (deviations, change controls, OOS results, document change controls, complaints)
• Chairing monthly QMS meetings and trending key performance indicators (KPIs)
• Conduct of internal audits
• Conduct of external GMP audits
• Ad hoc advice

Training Seminar

Presentation entitled “The Role of the QP and Release Requirements for IMPs” at the Global QA Meeting of a well-known Contract Research Organisation (CRO) headquartered in the US.

QMS Re-design and re-model

Redesign of a QMS for a UK client following internal restructuring and reorganisation, and the decision to outsource all Quality activities.

Previous Projects & Achievements

• Successfully designed and implemented Quality Management Systems for two privately-funded virtual biotech companies, encompassing R&D, GLP, GCP and GMP requirements;
• Successfully applied for a manufacturer’s licence (MIA(IMP)) for one of the above companies, and managed their subsequent MHRA GMP inspection with no critical or major deficiencies;
• Responsible for providing QA input into the design of a US biologics manufacturing facility, in Boston, MA, to ensure compliance with both EU and US requirements and participated in the associated FDA interactions;
• Extensive experience auditing contract manufacturers, laboratories and storage and distribution agents in the UK, US and Canada.