There is no standard for GMP audits that suggest that the audit conducted by the consultant should be only on site (practical based). Due this deadly pandemic situation of Corona the Consultancy firms are carrying out the virtual audits for their clients. Nevertheless, these remote audits have become routine for all those who want their audits to be performed by their choice of consultants but wanted to save their travelling expenses indirectly for the organizations cost savings.A lot of information on remote audits has been published in the last few months considering the requirement of the scenario and analysed some of it for the fulfilment of the GMP Certification for the organization. This article focuses at GMP audits and not at official GMP inspections.
Every company must operate GMP compliant processes as possible from the supplier in a realistic manner to provide good manufacturing practice in the management of the organization. It’s best to look at the task from different angles because that’s how we make ourselves aware of the different problem and hazards points available in the conduct of the process.
Also, Check –>> GMP Certification in India
What is GMP Audit?
A GMP audit is a comprehensive, third-party inspection for the practice of Good Manufacturing Practice to identify operational flaws and legal violations. GMP audits are meant to communicate a set of standards for the fulfilment of the GMP Standard requirements. The virtual audit is conducted by the listed down process to make it effective and worthy.
The Regulatory Review
Audits differ from inspections to inspections depending on the nature of the organization. Inspections are carried out by competent authorities and audits are carried out between companies. Audits are carried out for reviewing the outsourced activities (if any) and supplier qualification.
This review is also performed to provide clear requirements for a few GMP Certification audits. Accordingly, audits at active ingredient manufacturers for GMP Compliant. But due to the time when the pandemic is declared and travel restrictions that makes GMP Certification on-site audit impossible.
For all other audits an on-site audit is not stipulated by the GMP regulations. Clients can therefore establish alternative processes in the form of remote audits.
The Conservative Review
Remote audit could be a conservative assessment though it does not represent reality truthfully. But helps the organization to have adequate raw materials and implement correct actions to predefine framework for the management.
Conducting remote audit has its own advantages and disadvantages:
Advantages of Remote Audit
- Time Management
- Cost Saving
- Reduce Travel Dizziness
- Mentally active and energetic, etc.
Every coin has two side having advantages of remote audit also have its own disadvantages. They are:
- Plant tours of warehouses and clean rooms are difficult.
- Details are lost with inadequate camera.
- Behaviour of employees can be more difficult to observe.
- Auditors are less able to follow their intuition because overall picture is not transmitted.
Considering these all advantages and disadvantages one has to conclude that remote audits can be beneficial as well as insufficient as well. Hence it is not compatible with GMP requirements to conduct remote audits.
The Progressive Review
We have seen a massive improvement in technology in the coming recent month to support the upcoming scenario and requirements of the market to evaluate companies at a distance from almost anywhere in the world.
GMP Certification process
To make the GMP Certification process simple and quick. Hiring a consultant will guide you and your business through the following steps to achieve GMP Certification by providing.
- Gap Analysis Training
- Documentation & Test Report
- Process Audit
- External Audit
- Certification and beyond