GMP audits are conducted by third-party entities to ensure that a manufacturer is adhering to regulatory requirements.

Audits can be carried out by internal teams within a company, consultants, or regulatory inspectors. This article will focus primarily on internal audits and audits conducted by consultants. 

(Redica has some great resources in preparing for regulatory inspections, including a four-part series on FDA inspections.)

Internal GMP audits can help identify deficiencies in manufacturing operations before an inspection. This provides an opportunity to resolve these issues, otherwise, if they are observed during a regulatory inspection, this could result in repercussions such as a 483 observation, Warning Letter, Health Canada Initial Inspection Deficiencies, EMA Non-Compliance Reports, etc.

GMP audits are also conducted at suppliers such as contract manufacturing organizations (CMO) to ensure that quality systems are robust. Regulatory agencies expect companies using CMOs to ensure that outsourced operations adhere to GMP requirements.

A Word About Remote GMP Audits

A quality systems approach has often been used for GMP audits, though some experts caution that focusing strictly on quality systems could fail to identify potential data integrity issues.

Additionally, the COVID-19 pandemic forced firms to conduct remote audits. In fact, remote audits or a mix of onsite and remote, are likely to remain common. One challenge with remote audits is document sharing. Determining the appropriate scrolling speed along with the auditee being able to locate requested information in the document are some issues that consultants have seen. Technical challenges such as Wi-Fi connectivity issues and incompatible teleconferencing apps can also cause issues. 

Whether your audit is onsite, remote, or a mixture of the two, it is good to prepare for them!

Additional Resources

An Alternative to GMP Quality System Auditing in the Pharma Industry

COVID-19 Pandemic and Your GMP Audit Schedule for 2020

What Advice Do Industry Experts Have About Remote Audits?

Onsite versus Remote Audits

Remote Audits and Document Sharing

My Experience with Remote Audits

Be better prepared for GMP audits and inspections! See the most recent FDA for-cause GMP inspections involving sites manufacturing human drugs. Contact us today to learn more.

Recent human drug GMP for-cause inspections
Redica Systems Enforcement Analytics | Recent Human Drug GMP Inspections


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