Does your audit go well ?
The GMP – Good Manufacturing Audit is a tool that is mostly used by Pharmaceuticals manufacturers to check whether the food, medical, cosmetic and other products are in compliance with the quality and it is also ensure that they are consistently maintained. Using the GMP audit, you can protect your businesses, getting caught from the safety issues that occur in the product, the product recalls, and saves you from the legal and regulatory issues as well.
Let us have a look into the checklist that you need to prepare for a GMP audit:
One must have this checklist ready to measure that the products are in accordance to the manufacturing protocols that are in existence. They include,
- Doing digital inspection or audits using your handheld devices like mobile phones and tablets
- Keeping record of the evidences related to compliance and non-compliance items
- If any non-compliant items are captured, you need to have corrective measures for the same
- Preparing a comprehensive report for the audit that completed and preview those reports as well
- Generate reports that can be shared within the groups of the organization online
- Use digital signatures to promote accountability for the audits performed
- Generated reports can be shared in the PDF, word, excel or using a web link
The checklist that is listed above maps with almost 8 different systems as in:
- Building and facilities
- Quality control systems
- Materials management
- Quality management systems
- Packaging and identification labelling
- Purchasing and customer service
- Personnel and training
Motions of a typical GMP audit process:
Necessary information are collected from the auditor end – on site or remotely and those records are examined carefully. The auditors perform audit planning that involves the initial planning and conducting audit processes that occurs as a result of the initial assessment processes.
Then the documentations are collected during the visits, interviewing individuals who are involved in the specific processes, and also during the review of batch data that is generated from the manufacturing operations. It is also ensured that the documentation and the reports collected during this time are precise, clear and much easier to understand as well.
Documentation must include:
- Summary of findings
- Recommendations for corrective action
- List of non-conformities and other observations can also be included
The team of Global Quality Services will review the past audit process and the FDA inspection results – which includes the activities of all operations that the organization takes in hand and the ones that the organization has outsourced as well.
It is also recommended to take a pre-audit check before the day of actual audit, so that you can ensure that the team is well prepared with contracts and other documentations needed during the visit.
Quick tip for a GMP audit:
- Have a list of all the documents that are needed for the assessment during the audit
- Have a checklist of all the items needed for the GMP compliance in your respective facility
- Have someone in your organization available at all times during the process
Perform all these best practices to easily cross a GMP audit with qualified auditing professionals like Global Quality Services.
For GMP Certification, GMP Consultancy, GMP Expert service, GMP Documentation in Singapore, Philippines, Thailand – drop mail to [email protected]