Quality Auditing
Having been personally involved with a number of successful Regulatory Authority audits (e.g. MHRA, IMB) then our GMP auditing process will ensure any facility's requirements will satisfy current EU GMP requirements by ensuring that any corrective actions identified are actually carried out within agreed timelines.
Now with the adoption of ICH Q7a in EU Directive 2004/27/EC all Marketing Authorisation Holders are now required:
“to use as starting materials only active substances which have been manufactured in accordance with the detailed guidelines on GMP for starting materials”
As the Regulatory Authorities have accepted the use of 'third party audits' then through the use of our services we can ensure you will comply with your obligations under Q7a.
Wherever possible, confidentiality permitting, we would also consider the possibility for sharing audit reports so as to keep costs to a minimum.
Contract manufacturer Audits
We conduct in-depth Manufacturer Audits to assure the manufacturer has the ability to maintain full compliance with cGMPs and satisfy any additional specific issues that may be defined in your Marketing Authorisation. We also provide services for evaluating, selecting and monitoring a contract manufacturer.
Contract Laboratory Audits
We determine and monitor the cGMP compliance throughout the period of the relevant contract laboratory’s activities. Compliance to cGMP is required for all testing activities associated with the manufacturer for human use.
Supplier/Vendor Audits
We conduct inspection audits with each supplier/vendor of critical raw materials, components and supplies to assure the supplier/vendor's compliance to cGMP. In addition, we can assist you in developing a vendor audit programme and can participate with your personnel on audits.
Quality/Product Audits
We conduct in-depth Quality/Product Audits to assess the completeness of the company's quality system and audit trails by defining the product critical items, enabling the audit team to focus on issues that affect product quality.
Computer System Audits
We provide guidance on how computer systems should be validated to meet cGMP requirements and/or provide highly independent audits to assure your computer software vendors also meet the requirements to ensure a GMP validated system.
General cGMP Compliance Audits
We provide cGMP Compliance Audits to you on a one time or annual basis. We conduct highly independent and impartial audits and provide reports to you with suggestions for improvement.
