Purpose

In order to verify compliance with the principles of GMP regular internal audits should be performed in accordance with an approved schedule. This also includes the auditing of important suppliers to assure the quality of the incoming goods (e.g. raw materials). Finally audits and inspections are performed by customers and the relevant authority (e.g. FDA, SFDA, EDQM) to decide based on this spot view whether you comply or not with the relevant Good Manufacturing Practice guidelines.

Services

• Consultancy and training on the topic audit & inspections
• Providing templates and help to establish the self inspection program and supplier auditing program
• Doing mock inspections in preparation of real inspections
• Assist during real inspection and support the wrap-up including the authority communication

Types of Audits

• Internal audits (self-inspection)
• Supplier audits (to make a supplier an approved supplier)
• Customer audits (audits done by your customers)
• Authority inspections (SFDA, US FDA, EU authority)

Prerequisites

• Basic GMP system should be implemented and work
• Staff of the manufacturer should have been appropriately trained.
• SOPs describing audit perfomance and/or preparation should be in place.

Procedures

• Discuss with client about their requirements – type of audit and actual GMP-state (Signing of Secrecy Agreement recommended).
• Prepare an offer (fixed rate dependent on the type and extend of the audit).
• Sign the contract and project commence.
• Prepare the relevant (audit) SOP as far as not available (based on templates)
• Training and instruction of relevant persons (dependent on the kind of audit)
• Execution on site:
  • Perform an internal audit or
  • Perform a supplier audit or
  • Accompany an audit/ inspection executed by a customer or authority
    (in this case a pre-audit/ mock inspection is recommended)
• Prepare a final report and discuss with the relevant persons
• Prepare a to-do list and give recommendations on improvements
• Help to answer the customers and authorities questions respectively

Important Note

A good preparation especially of customer and authority audits and inspections is of high importance. Gemro provides guidance in preparation of necessary company presentations and give general guidance on how to prepare and how to behave.

Finally the result of audits and inspections heavily depends on the onsite situation whether GMP is fulfilled and active or not. So far we heavily recommend to do a self initiated gap analysis or at a minimum a GMP spot view as early as possible to be self confident about the GMP situation.