GAMP Services provide third-party vendor audit services for the pharma manufacture. It includes all types of vendors like raw material vendor, machinery supplier, Software and IT vendor, packaging material vendor or contract manufacture.
Auditing in simple terms could be defined as an inspection of a process or a system to make sure that it complies with the requirements of its intended use.
There are two types of audits that are conducted:
- Internal Audit (Self Inspection):
- External Audit: This is conducted for the suppliers or any outsourcing operations carried out by the pharmaceutical industry. The contract giver (Industry) is responsible to access the competence of the Contract acceptor (supplier or any other outsource operations department) as per the GMP guidelines.
The rationale for Conducting Internal and External Audit as per ICH Guidelines Q10:
PROCEDURE FOR CONDUCTING AN AUDIT:
- Frequency of Audit:
- Responsibilities:
- Documentation
- Audit Preparation.
- Conducting of Audit
- Completing and Follow Up Of Audit
Third party Auditing is an integral part of pharma operation and cannot be neglected as it helps in product realisation, process performance, quality monitoring. It is must tool for continuous improvement of quality system of an industry.