Audit Assistance
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 are performed by the relevant authority (FDA, SFDA) to decide based on this spot view whether you comply or not with the relevant Good Manufacturing Practice guidelines. We help you to:
- learn and experience the principles of the audit
- establish the self inspection program
- be prepared for different types of audits
Types of Audits
- Internal audits (self-inspection)
- Supplier audits (to make a supplier an approved supplier)
- Customer / authority audits (inspection on site for compliance)
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 dependend 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 (dependend on the kind of audit)
- Execution on site:
▪ Perform an internal audit or
▪ Perform a supplier audit or
▪ Accompany an audit executed by a customer or authority (in this case a pre-audit is recommended)
- Prepare a final report and discuss with the relevant persons
- Prepare a to-do list and give recommendations on improvements)
Important Note
- Plant qualification, calibration & maintenance
- Process validation
- Cleaning validation
- Validation of water systems
- Impurity profile validation analytical methods
- Validation computerized systems
- Change control system
- GMP - Training
- Self – Inspections
- Consistency of filed documentation with the on-site situation (DMF)
- Review of batch documentation!
- Development report
- Quality management
- Deviations of product specifications
- Failure investigation
- Long term stability
- annual product review
cGMP Deficiencies
Most common cGMP deficiencies cited during API inspections in EU member states fiscal years 95-98
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What is GMP
Audit Assistance
