Somerset House Consultants - Active Pharmaceutical Ingredient Audits, GMP Compliance, Investigational Medicinal Products
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Somerset House Consultants has long experience of design and management of pharmaceutical development, manufacturing, and quality assurance programmes.
Somerset House Consultants Ltd - GMP Compliance
We specialise in helping emerging and “virtual” pharmaceutical companies worldwide to select, audit and manage sub-contractors for their outsourced development and manufacturing projects. We are flexible and responsive to meet your specific needs.
Quality Assurance and QP Release of Active Pharmaceutical Ingredients (API), Investigational Medicinal Products (IMP) And Marketed Products
Our services include:
- Setting up Quality Assurance systems
- Supplier audits
- GMP compliance
- Qualified Person Release of Active Pharmaceutical Ingredients (API), Investigational Medicinal Products (IMP) and marketed products
- Manufacture and Release of Clinical Trial Supplies
GMP-Compliant Quality Assurance Systems
Somerset House Consultants helps companies to set up GMP-compliant quality assurance systems that are appropriate to their needs. We provide a range of services to ensure that you and your contractors meet all current requirements, including:
- Preparation of Standard Operating Procedures
- Preparation of Validation Master Plans
- Preparation of Site Master Files
- Staff training
Our expertise covers Active Pharmaceutical Ingredients, Investigational Medicinal Products, sterile and non-sterile dosage forms and biotechnology products.
Good Manufacturing Practice Compliance Audits For Active Pharmaceutical Ingredients
Somerset House Consultants carries out Good Manufacturing Practice compliance audits for Active Pharmaceutical Ingredients, Investigational Medicinal Products and marketed products, including:
- Supplier and contractor audits
- Audits of companies wishing to import products into the EU
- Pre-audits in preparation for competent authority (eg EMEA, MHRA) inspections
Clients receive full audit reports, including proposals for actions to correct GMP deficiencies.
Investigational Medicinal Products
Somerset House Consultants has wide experience in manufacturing and despatching Investigational Medicinal Products for clinical trials worldwide – from small bioavailability studies through to multinational Phase III trials. We propose and manage solutions specific to particular trials, or work with your existing manufacturers to ensure that the supplies comply with legal requirements.
We support your trial from initial planning through to the final report, including:
- Ensuring compliance with Good Clinical Practice and Good Manufacturing Practice
- Qualified Person release for clinical trial supplies
- Selection and auditing of manufacturers
- Setting up Technical Agreements with manufacturers
- Maintaining Product Specification Files
Pharmaceutical Virtual Quality Management™
Our Virtual Quality Management™ product is specifically designed to help small pharmaceutical companies comply with regulatory requirements. A dedicated quality professional works directly for you on a part-time basis; much more cost-effective than employing a full-time employee or interim manager.
Amongst the tasks carried out by this quality assurance specialist are:
- Setting up quality systems and Standard Operating Procedures
- Auditing CRO’s and Investigational Medicinal Product manufacturers for compliance with GCP and GMP
- Releasing supplies
- Drawing up Technical Agreements with each contractor
- Good Manufacturing Practice documentation reviews
Ongoing project reviews and problem solving
Contact
Robert Haslam
Somerset House Consultants
Somerset House
Ball Road
Pewsey
Wilts SN9 5BN
UK
Tel: +44 1672 562225
Fax: +44 1672 562225
Pharmaceutical Development Projects
- Outsourcing Your Pharmaceutical Development Projects »
Management of outsourced pharmaceutical development projects, and ensuring compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) requires a different range of skills to managing in-house programmes.
Somerset House Consultants News
- The Challenges of Outsourcing Pharmaceutical Development »
Robert Haslam
Outsourcing has been found to be an effective and cost-efficient way of developing new products. Many so-called "virtual" companies have no in-house development or manufacturing capability, and outsource everything.
Pharmaceuticals Directive
- Are your Drug Substance suppliers GMP-Compliant? »
Until now, pharmaceutical companies could source their drug substances from multiple suppliers, without needing to know where or how the materials were made.
Clinical Trials
- The EU Clinical Trials Directive - One Year On »
Robert Haslam
The EU Clinical Trials Directive has been in operation since May 2004. It applies to all members of the European Economic Area (EEA), ie the 25 Member States of the EU plus Norway, Iceland and Liechtenstein.
Contractor Selection
- How Do You Choose A Contractor? »
Robert Haslam
Companies that outsource aspects of their projects rely on the abilities of the contractors to achieve success. Choosing an inappropriate contractor can seriously delay projects and lead to lost revenue or additional costs.
Product Quality
- Product Quality Reviews »
Robert Haslam
A recent amendment to the EU Guidelines for Good Manufacturing Practice has introduced a requirement for holders of pharmaceutical Marketing Authorisations to carry out regular quality reviews on all of their products.
Clinical Trials Quality Assurance
- Quality Assurance Services for Clinical Trials »
Many pharmaceutical development companies with projects entering Phase I and II clinical trials are “virtual” companies, and management of the trials and the manufacture of the Investigational Medicinal Product is outsourced to contractors.
Counterfeit Drug Detection
- Counterfeiting of Pharmaceuticals and GMP Audits »
Robert Haslam
Somerset House Consultants Discuss the importance of regular GMP audits to prevent pharmaceutical counterfeiting
Investigational Medicinal Products
- Investigational Medicinal Product Certification »
Qualified Person Certification of Investigational Medicinal Products
Pharmaceutical Risk Management
- Risk Management, ICH Q9 »
A recent ICH guideline (ICH Q9) describes the use of risk management procedures as part of the quality management of pharmaceutical manufacturing and development.
Supplier Audits
- GMP Auditing of Active Ingredient Substance Suppliers »
Robert Haslam
EU marketing authorisation holders must use drug substances that have been manufactured in accordance with Good Manufacturing Practice (GMP).
