Auditing services

Our certified auditors use ISO 19011 auditing tools and can audit to the following standards (include but not limited to):  

  • ISO 9001

  • US GMP 21 CFR 210, 211, Part 11, 600

  • EU & UK GMP

    • EU GMP for Finished Pharmaceutical products Part I, Part III and associated guidances

    • Part IV - GMP requirements for Advanced Therapy Medicinal Products 

    • API Distribution and Manufacturing using UK and EU GMP standards Part 2, and 2015/c 95/01 

  • ICH Q7 

  • ICH E6 

  • Medical Device ISO 13485 / FDA 21 CFR 820 

  • Consumables and Excipients using:

    • ExiPact

    • ISO 9001 standards 

    • ISO 13485 or MDSAP as applicable 

  • Laboratory conducting QC testing to GMP standards and ISO 17025 various technical standards and proficiencies e.g. BS, EN, ISO ICH M10 

  • GMP Packaging site audits (Primary and Secondary) 

  • Printed packaging audits PQA 9000 PS 

  • ISO 22000 Quality Standards for Food grade materials 

  • ISO  11137 Sterilisation  

  • ISO14937 Aseptic manufacturing of healthcare products 

  • Medical Device Single Audit Program (MDSAP) a unified international standard for medical device auditing 

We support the following products: 

We provide tailored support for manufacturers/investigators and distributors of:

Pharmaceutical Formulations

Creams and Ointments

  • Liquids, Foams, Syrups, Suspensions

  • ∙ Suppositories

    ∙ Powders, Granules

    ∙ Tablets, Capsules (Functional Coatings, Multi-layer Tablets)

    ∙ Gels, Patches

  • ∙ Solutions (Small & Large volume): in vials, bags, ampules, bottles, and blow-fill-seal systems

    ∙ Freeze dried products

    ∙ Irrigation solutions

    ∙ Oil based products (sterile creams and ointments)

    ∙ Total parental nutrition

    ∙ Ocular (eye), Otic (ear) and Nasal, Single use and multi use systems

    ∙ Biopharmaceuticals Drug substance manufacturing and formulation and fill

    ∙ Gene Therapy products

    ∙ Cell Therapy products (autologous, allogeneic)

    ∙ Engineered tissue products

  • ∙ Prefilled Syringes

    ∙ Auto injectors

    ∙ Implantable pumps,

    ∙ Bio-degradable implantable polymers

Medical Devices

Class I (Sterile and non-sterile)

Class IIa Class IIb, Class IIm (sterile non-sterile)

Class III (sterile)

 

 AFFILIATIONS

CLIENT FEEDBACK

  • “Thomas was a colleague of mine whilst I was acting as a Qualified Person. He displayed a comprehensive knowledge of applicable legislation and industry GxP expectations. His meticulous planning was of great benefit during GMP audits and together with his flair for technology and software made him a pivotal team member.”

    — QP and Ex Inspector

  • “TDP is a privilege to work with. Thomas and the Team work efficiently with extreme diligence and care. Providing prompt batch review records that allow easy and expedient batch release of ATMP IMPs.”

    — Head of Quality and QP

  • “TDP has helped me build out my QMS to enable UK WDA registration with only comments from the Inspectorate. They always met the agreed timelines allowing for easy project management.”

    — Head of Quality and QP

  • “As the CEO of a large pharmaceutical company having access to TDP and the team means I have had access to precise and detailed advise well researched and reliable. It has enabled us to solve importation, supply chain problems and quality issues. The speed and variety and professionalism of service is impressive for such a young company, led by such a young MD. Privilege to work with. Looking forward to a long and strong partnership as a member of my senior advisory team!”

    — CEO large pharmaceutical company

  • “Thomas’s is an auditor of a type and Quality the like I have rarely encountered. The depth and detail of his work is phenomenal, not only that he took the time after the audit was said and done to give us a brief set of option appraisals to answer mine and my teams' questions in full and with pragmatism.”

    — Head of Quality, Multinational Pharmaceutical Manufacture Company

  • “Thomas has a broad knowledge of all GXPs/Quality regulations on a global level. Thomas has an excellent eye for detail whilst executing audits and has overall high understanding of all topics which need to be covered during an audit. I have personally audited with Thomas which involved high profile contractor audits known for critical Findings and recalls. Thomas identified multiple major/critical Findings. Thomas is a skilled auditor, and he is also in the process of training as a QP. Amazing Contract Auditor.”

    — Head of Audit, Multinational Pharmaceutical company

  • “Lucia is a privilege to work with an exceptionally diligent and pragmatic QP, she enabled us to obtain our MIA, building it from scratch to meet our custom and quite nesh needs. Moreover, the inspector when granting us our licence said that in the last 10 years this is the first time, she has given no observation and not even a comment!”

    — Managing director SME pharma company

  • “Lucia’s passion for patient first, is evident in all she does. Her technical acumen and attention to detail makes her an asset! What is more important is that she educates and explains always making the time.”

    — Head of Quality and QP

  • “Nick is known for his ability to see and smell out poor practice, but unlike many auditors/consultants he doesn’t just report it. He will explain the issues and problems consequences to me as the client but more importantly to the individual at the time. He is always willing to go the extra mile.”

    — Senior Director of Quality, Multinational pharmaceutical company