Chilford Pharma Ltd

We can provide GxP validation services such as:

• IT infrastructure qualification (including cloud solutions) 
• Computer system validation 
• E-QMS selection and validation 
• Process Validation (PV/PPQ) support
• Set up of ongoing process verification systems 
• Generation of Validation Master Plans and Policies    

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We can offer bespoke training tailored to your specific requirements including:

• Critical Thinking - highly recommended to control unwanted and hidden biases and one of our key foundations for improving efficiency, quality and compliance to drive your business forwards
• GxP training
• Qualified Person sponsorship and support
• Quality Management Systems
• Regulatory updates
• Sterility Assurance and Biological Safety

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We can provide contract Responsible Person (RP) services for the human pharmaceuticals and animal health industries as defined in 2013/C 343/01. 

• MAH holders
• Distributors
• Responsible Person for Importation
• GDP consultancy

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We can provide contract Qualified Person (QP) services for the human pharmaceuticals and animal health industries as defined in 2001/83/EC and 2001/82/EC as amended across a range of dosage forms including sterile small molecule and biologicals products. 

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We offer a structured and sustainable Pharmaceutical Operation Excellence (POEx) program that can be tailored to your organisation to increase efficiency, reduce waste and improve quality and compliance. 

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We offer a range of GxP consulting services.   Areas of expertise include:

• Cloud IT infrastructure and software
• Company start-ups
• Continued Process Verification / Ongoing Process Verification
• New facility design
• Quality Management Systems
• Quality Target Product Profile (QTPP) and design space establishment
• Risk Management
• Sterility Assurance (including contamination control strategies)

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We know that lean and efficient systems and processes lead to enhanced business performance, product safety, quality and efficacy and regulatory compliance. We can assist with: 

• Implementing a sustainable lean program
• Process identification and mapping
• Value stream mapping
• Visual Management
• 5S 
• Investigation maps

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Assuring continual Data Integrity is fundamental to GxP operations. We offer Data Integrity services, providing support to ensure your organisation has compliant and effective Data Integrity by Design systems and processes. We can offer a broad range of Data Integrity services including: 

• Data Integrity gap assessments and audits
• Data Integrity compliance remediation
• Generation and implementation of Data Integrity by Design systems, processes and documentation
• Generation of Data Integrity policies and governance procedures
• Generation and implementation of proactive Data Integrity Risk Assessment systems

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If a company finds itself with an inadequate compliance status or is facing regulatory action, Chilford Pharma can help.  We have experience of turning around the compliance status of organisations. We provide structured pathways not only to regaining an adequate compliance status, but to integrate compliance as a pillar of the organisation in a sustainable manner. We can correct very costly poor compliance and make full compliance a commercial advantage for your organisation. 

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We have a wide range of GxP auditing capabilities including raw material suppliers, API manufacturers, biological and small molecule finished product manufacturers (across a range of dosage forms), storage facilities and wholesale dealers. 

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