QMS development

Your Quality Management System (QMS) is the first place GMP auditors will ask to see when they visit. The key is to “say what you do and do what you say.” Your QMS must document the processes used in your facility and then you need to ensure that your staff are following those documented procedures (and there’s records to prove that they are).

If you do not have a Quality Management System in place

If you need to implement a QMS CiPharma are experienced in all the core procedures needed for GMP compliance and the writing of the QMS itself.¬†CiPharma will supply the resources to implement the QMS for you. We’ll research and write it all for you, train your staff and hand it over to your internal resources to maintain.

If your Quality Management System needs improvement

If you are preparing for a GMP audit or an auditor has indicated that your QMS is inadequate, we can offer the following:

  • A gap assessment to determine where you should focus your resources to ensure compliance
  • Help with preparing a response to the audit findings and a remediation plan that will deliver a successful subsequent audit
  • Resources to improve your existing QMS to meet compliance requirements.