An Introduction

GMP Auditing service by TGA or FDA Inspectors may be an opportunity for self-reflection. An imminent GMP audit provider may inspire continuous improvement initiatives, even if they have been considered for months or years but have not yet been implemented. A lot of pre-audit preparation centres on action rather than prolonged debate.

Product Quality Management Officers, Quality Risk Management, and other managers ensure GMP is followed across all processes, and portions of their therapeutic products manufacturing operations are especially concerned during TGA and FDA audits.

Avoiding TGA or FDA Audit Failures with GMP Auditing and Self-Inspection Processes

An inspection by the TGA and the FDA may be avoided by conducting your self-inspections (GMP audit).

It is essential to conduct self-inspections to understand better operational issues and non-compliance areas, such as recurrences of deviations and insufficient CAPA (such as failing to validate new processes and equipment).

Solutions and proof of work on production gaps that might affect the quality and safety of your goods or medical devices can be found with their assistance.

You’re worried about a forthcoming audit by the TGA or FDA (GMP Auditing)

Self-inspection and improvement activities are one strategy to lessen the impact of a Regulatory Inspection/Audit.

However, the GMP auditing service criteria necessitate that you begin with one of the most fundamental tenets.

An excellent example is ensuring that your employees (and those of your contractors and suppliers) have received up-to-date GMP training from GMP auditing services (such as PICS/cGMP).

Appropriate digital preservation of their GMP certifications is included.

In addition, finding time for a self-inspection might be a challenge, but if you’re frightened to look or don’t have enough time, you’ll likely pay the price when it comes time for Pharma audits.

Failure Causes of GMP Inspections and Audits (TGA or FDA)

The TGA or FDA Inspection Officer is more likely than your quality assurance teams to find GMP compliance issues in regulatory audits.

Which areas of non-compliance result in regular fines or shutdowns of operations?

Which GMP compliance breaches potentially lead to expensive product recalls and legal responsibility issues during TGA and FDA inspections?

Training staff and contractors on current GMP compliance standards 

According to recent TGA and FDA briefings, poor GMP staff training is one of the top ten causes of regulatory Pharma audit failures.

Gaps in GMP training were cited as either the fifth or sixth most prevalent cause of a GMP audits provider failure in recent forums, one including TGA inspectors in Australia and the other featuring FDA inspectors (the Joint FDA-PDA meeting).

Employee GMP training may have been outdated or insufficient, or there may have been insufficient training of contractors and staff (non-current training or no current training records).

Regulatory GMP inspections by the TGA or FDA, or other regulatory authorities

PICS/GMP audit failures are most often caused by dynamic circumstances, despite the availability of several GMP training alternatives, including e-learning and blended training methodologies.

Put another way, we’ll educate staff next month, next year, or whenever we have any downtime on the assembly line.

The Bottom Line

After rigorous inspections and open communication between auditors and your supply chains, it is felt that one of the most critical works is the ability to give timely Pharma audit reports.

The quality and quantity of relevant facts may be better recorded by prioritizing the Pharma audit report writing as a time-sensitive task, and therefore the quality of corrective suggestions can be maximized.