Somerset House Consultants Active Pharmaceutical Ingredient Audits, GMP-Compliant Quality Assurance

Somerset House Consultants are an experienced consultancy organisation offering design and management services for pharmaceutical manufacturing, development and quality assurance initiatives. Established in the United Kingdom, in 2001, the company has a broad client base across Europe, Australia, India, Japan and the United States.  Somerset House offer an adaptable range of services is highly adaptable to support clients in a variety of tasks.

Services available include:

• Technical Agreements
• Corrective action for GMP non-compliance
• Audits and supply chain traceability services
• Management and contractor selection
• GMP compliant QA systems
• GMP Training
• Clinical trial supply production and release
• Quality Risk Management Programmes
• QP declarations for Active Pharmaceutical Ingredients
• QP release for Investigational Medicinal Products, Active Pharmaceutical Ingredients and marketed products.

Pharmaceutical Quality Assurance

GMP-Compliant Quality Assurance Systems

Somerset House Consultants can assist clients in the development of GMP compliant quality assurance systems, or perform corrective action in the event of FDA483s, Warning Letters or EU deficiency letters.

Somerset House's services can help your company and your suppliers to meet ISO9001 regulations and FDA / EU guidelines for Good Manufacturing Practice.

These include:

• Validation master plans
• GMP training
• Standard Operating Procedures
• Technical and quality agreements
• Site Master Files
• CAPA Quality Training
• Liaising with Regulatory Authorities

Somerset House Consultants are experienced in working with Investigational Medicinal Products, non-sterile dosage forms, Active Pharmaceutical Ingredients, marketed products, herbal products and biotechnology.

Quality Risk Management

Somerset House Consultants can develop quality risk management procedures.  The company performs full risk assessments for adherence with ICH Q9/EU Annex 20 regulations.

These include

• Risk review
• Risk Control
• Risk registers
• Risk assessment

Supply Chain Traceability and GMP Audits

Somerset House's ISO9001-certified auditors perform GMP compliance audits for Investigational Medicinal Product, Active Pharmaceutical Ingredient, marketed product, packaging material and excipient manufacturers across the globe. A range of services are available relatiing to GMP audits and traceability.

These include:

• Contractor / Supplier GMP Audits
• Pre-audits before FDA, EMA or MHRA inspections
• Development and administration of corrective action plans following GMP nonconformance
• Company audits for clients hoping to import products to the EU.
• Supply chain traceability audits

Audits are performed in line with FDA, ICH Q7, EU GMP, IPEC or ISO9001:2008 requirements.

GMP Training Programmes

Somerset House perform in-house GDP and GMP training programmes to meet specific client requirements. Previous courses have included:

• FDA vs. EU Good Manufacturing Practice
• Requirements for Controlled Drugs
• Good Distribution Practice (GDP)
• ICH Q8/9/10
• Annual Product Reviews
• EU and FDA GMP inspection preparations
• Air Handling Systems
• Pharmaceutical Water Systems
• Good Manufacturing Practice for IMPs
• Risk Management

Investigational Medicinal Products

Somerset House are experienced in the manufacture and distribution of Investigational Medicinal Products across the globe for clinical trials at all stages from phase III multinational trials to small-scale studies of bioavailability.

We will put forward and manage solutions for specific trials, or collaborate with current manufacturers to guarantee that supplies conform to legal requirements.

Somerset House Consultants can support a trial through its entire life cycle from the early planning stages to the final report.  Services include support for:

• QP release for clinical trial study supplies
• Product Specification Files
• Selection and auditing of manufacturers
• GMP and Good Clinical Practice Compliance
• Establishing Manufacturers' Technical Agreements
• Qualified Person declarations for non-European manufacturing facilities

Qualified Person Batch Certification

Somerset House offer experienced Qualified Persons on to perform batch certification of marketed products and IMPs on either a permanent or temporary contract.

We are experienced with both non-sterile and sterile dosage forms, herbal products, biotechnology and small molecules.