Conducting external audits and internal audits or self-inspection audits of outsourcing operations and suppliers are core elements of a great pharma quality system. The GMP audit checklist is aimed at helping in the systematic audit of a unit that is responsible for manufacturing finished products or drug components. The adequacy of any process is subject to the auditor’s interpretation. Therefore, the GMP Institute and ISPE do not accept any liability for any regulatory actions or observations coming out from the use of the audit checklist. 

Instructions Related to GMP Audit Checklist

Before you will start an on-site GMP audit, it is recommended to plan out the pharma audit. While preparing the pharma audit report, you should go through the past pharma audits. You should also make a note of proper indications of potential problem items and areas that have been identified for ensuring corrective action in the past audit. If you wish to ensure the success of your GMP audit, you can go through the comprehensive checklist. 

If you are not aware of the pharma GMP auditing and inspections, you should inquire about the type of product manufactured and how it will be organized by function and personnel. If you are taking help from professional pharmaceutical audit consultancy services, you should check into important considerations during GMP auditing.

Factors to Consider During GMP Audit Checklist

When you hire services from reliable GMP audit companies, here are some factors to consider:

• Maintaining and Using a Written SOP for GMP Auditing: Set up a well-written GMP audit procedure to make sure that all audits are carried out in a consistent manner. Moreover, GMP audit processes should also meet specific minimum requirements. The audit procedure serves to be the roadmap to ensuring a successful audit.

Some basic information you can include in the audit process is the frequency of audits, the systems you should check, whether audits are unannounced or announced, and who should be present in the audit team. 

• Assuring Confidentiality of Outcomes: It is extremely crucial to analyze and confirm the confidentiality of outcomes. It is because an auditor is responsible for fostering a great relationship with people involved in the auditing process. Ensure that others know that you will not discourage them. Make a reminder that you are conducting the audit process to ensure that there are no flaws in the quality systems.
• Using Checklists As Per the Requirement: With proper pharmaceutical audit consultancy, you can come across specific guidelines and checklists. You can think of customizing and using the same as a guide to your auditing procedure as per the requirement. 
• Ensuring All Auditors have Relevant Qualifications: Detailed GMP regulations require that employers should be effectively qualified (through in-depth education, training, and experience) for conducting the jobs successfully. Therefore, it should be documented properly that auditors are capable of conducting the respective duties effectively. You can ensure overall success by understanding essential components of the GMP audit. 
• Eliminating Conflicts of Interests: Integrity is a crucial component of any pharma GMP auditing procedure. When you ensure integrity, it helps in eliminating all conflicts of interest that you might have. 

Conclusion 

The purpose of the GMP audit is to ensure that your product quality is as per the expectations of the end customers. Therefore, you should consider all important factors with help from reliable pharmaceutical audit consultancy services.