Nowadays, auditing is key for all pharmaceutical business either for evaluation of vendors, contract manufacturer, and service provider or for benchmarking and assessing the compliance level of the organization.

The GMP requirements are continuously changing (cGMP). To comply with the cGMP requirements, the pharmaceutical company auditors or the professionals who pursue to become auditor should know the value added auditing techniques

The traditional audit is having the compliance approach. Normally, it mainly focuses on the compliance of quality management systems with the customer requirements, statutory and regulatory requirement, relevant quality standards, organization procedures, and policies etc.

The traditional audit approach does not take in to account about effective implementation of the process. It just checks the compliance with specific clauses of the regulatory guidance.

Auditing in Compliance

Nowadays, there is a need to do some value addition in the auditing so that it won’t just fault finding exercise. The main purpose or benefit of value added auditing is to develop a review procedure of a specific system or process so as to ensure the processor system is effectively implemented. This value added auditing techniques helps an organization in improvement with respect to cGMP compliance.

It also enables the risk-based thinking process. The risk assessment strategies are traditionally applied for defining the frequency of the audits, however, we can apply the risk-based thinking for identifying the critical checks/systems/procedures to be reviewed. The criticality can be assessed based on supplier issues, customer complaints, feedback or changes made in the process, product specification, specific requirements etc.

Auditing Tree

The value added auditing techniques supports the combination of horizontal and vertical audit rather than only horizontal audits. To achieve the goal of this auditing, the auditor can go upward (following the process flow) or downward (reverse of the process flow).

The one major focus of value added auditing is to review the processes which are interconnected. This helps in the evaluation of compliance as well as finding the gaps, a reason for gaps and provide suitable solutions in the filling the gaps or compliance improvements.

This technique can be applied for supplier auditing also. Because overall improvement in the compliance level of the supplier can lead to improvement in the product quality in which the ultimately the auditor (Auditor’s organization or country) is interested. Of course, this technique can have added advantage for self-inspection so that a common goal of compliance improvement can be achieved.

Traditional vs Modern

Author: Mr. Hitendrakumar Shah, CEO - NADH+ GXP Compliance Services

Email:, Ph. No: +91-9712932892