TOC Consulting
Auditing
Internal Auditing
Self-inspection is a GMP requirement. But training and maintaining the skills of dedicated quality auditors is difficult and expensive.
TOC Consulting has access to qualified auditors with the skills and expertise to carry out quality audits for you.
TOC Consulting can evaluate all aspects of your quality system, identify strengths and weaknesses, and advise on actions to be taken.
We can also carry out targeted audits on specific operations or specific elements of your quality system, and report on their compliance status.
Our audits are carried out based on defined quality standards such as European Union GMP, FDA GMP regulations (CFRs 210 and 820), ISO 9001, etc.
We will be happy to discuss your needs and advise what we can do to support you.
Suppliers of Materials and Services
Current GMP regulations require that the manufacturer of the finished dosage form can stand over the GMP compliance of the manufacturer of the active ingredients.
Additionally, current European Union GMP requires that critical suppliers of excipients also conform to an appropriate quality standard.
TOC Consulting can carry out the audits necessary for you to meet these requirements. We can audit against the following standards:
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FDA cGMP CFR 210
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EU GMP Volume 4 Part 1 for Drug Products and associated Annexes
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EU GMP Volume 4 Part 2 for Active Pharmaceutical Ingrédients
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EU GMP Volume 4 Part 4 for Advanced Therapy Medicinal Products (ATMPs)
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EU Good Distribution Practice
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ISO 9001
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ISO 13485
Do not hesitate to contact us to discuss how we can help you to meet your obligations in respect of auditing of suppliers and service providers.
Gap Analyses against defined standards
A full gap analysis is more detailed than an audit.
Our gap analysis programs drill down into the details of an operation, and compare the actual implementation of your systems with the standards defined by regulatory agencies, industry bodies, and others.
A gap analysis evaluation can be broad spanning the entire quality system and the entire company operation, or it can be directed to a specific area of activity within the quality system.
TOC Consulting can advise whether you are compliant, and also give direction on how to address and close any gaps found.
Risk Assessment and Reduction
Where are the risks in your organisation and your operations?
People, processes, materials and systems can give rise to risks, or they can reduce those risks.
TOC can support you in evaluating the risks that currently exist, determining what action may be required and we can also support you in implementing that action.