Top 10 GMP Audit Failure Reasons: FDA and TGA Inspection Findings
Preparing for GMP/PICS Audits by TGA or FDA Inspectors can be a time for introspection. An upcoming GMP audit can even provide inspiration for initiating a continuous improvement initiative, perhaps discussed for months or years yet not yet implemented. So pre-audit preparation is all about focusing on actions, rather than endless discussions.
Yet TGA and FDA Audits are a particularly stressful time for Product Quality Management Officers, Quality Risk Managers, and other managers responsible for ensuring GMP is followed throughout all processes and part of their therapeutic goods manufacturing operations.
In fact, when you first find out you’ve got a TGA inspection or FDA inspection coming up, you’re likely to feel a bit like this.
- That’s often because you’re well aware that your paperwork and digital documentation, training programs, CAPA and other quality systems have notable gaps.
- Some compliance issues may even be large enough to keep you awake at night; wondering how you’ll manage it all.
- As the TGA or FDA inspection date looms closer, stress levels often skyrocket. In fact, employee turnover around audit time is not uncommon. But with management ultimately responsible, this leaves the organisation even more exposed to compliance notices, penalties/fines and potential shut-downs.
Stressed about an upcoming TGA or FDA Inspection (PICs/GMP Audit)?
- One of the ways to reduce the stress of a Regulatory Inspection/Audit is through self-inspections and improvement initiatives.
- Yet even those measures require you to start with one of the very basic tenets of the rules for GMP.
- That’s making sure your people (employers, contractors, vendors) are up to date with current GMP training (PICS/cGMP)…including proper digital storage of their GMP training course certificates.
- Plus, managing to schedule time for a self-inspection is often one of the issues — but being afraid to look, or shy on time to self-inspect, means there is typically a price to pay at audit time.
GMP Audits and Self-Inspection Processes: Avoiding TGA or FDA Audit Failures
- Self-inspections are certainly a good way to avoid GMP compliance failures when it’s time for a TGA inspection and/or an FDA inspection (GMP audit).
- Self-inspections can help you better understand the full extent of your operational problems and non-compliance areas, such as repeated deviations, inadequate CAPA, and other drug safety, quality and efficacy problems (such as failing to validate new processes and equipment).
- They can help you find solutions and provide evidence you’re working on any production gaps that might impact the safety, quality, and efficacy of your products or medical devices.
Yet far too few operators perform self-inspections, which could have saved them heartaches — and headaches — and audit failures or shut-downs — over time. For self-inspection training or audit response assistance, contact PharmOut (global Pharmaceutical GMP Compliance, Engineering and Validation experts). Or for a short e-learning course to assist you with preparing for TGA/FDA inspections (GMP audits), click here. Why is that the case?
Typically, like the GMP training gaps identified below, it’s partially a time-management factor and partially a budget-management factor. Both require a prioritization of the most basic and pivotal components of GMP compliance, upon which all other factors often rest.
In simple terms, you can’t expect an employee to fulfil GMP obligations they’re not familiar with, or are out-of-date on current PICS training, if they had adequate training at all. The same is true for your contractors. And TGA Inspectors and FDA Inspectors recognise this as a pivotal aspect of compliance; and they’re sure to investigate the actual training and development of your operational employees.
So what can you do? You can start by auditing your training and development records via a self-inspection; and employing e-learning or blended learning solutions (public courses plus online GMP training) when you discover current GMP training gaps.
GMP Inspections and GMP Audit Failure Reasons (TGA or FDA)
- What are some of the most common GMP compliance gaps spotted during regulatory audits, more by the TGA or FDA Inspection Officer than by your quality assurance teams?
- Which non-compliance areas lead to frequent penalties or operational shut-downs?
- Which GMP compliance failures could lead to costly product recalls and legal liability issues, discovered during TGA inspections and/or FDA inspections?
We’ll be posting an article about the 10 most common PICS/GMP audit failures soon, but we’ll share with you one that repeatedly comes up in manufacturing operations.
One very common cause of failing TGA or FDA inspections is the gap in training employees and contractors in current GMP compliance; and keeping training, and training records, current.
One of the Top 10 Causes of regulatory audit failures relates to inadequate GMP employee training, according to recent TGA and FDA briefings.
In two recent forums, one featuring TGA inspector(s) in Australia and one featuring FDA inspectors in America (the Joint FDA-PDA conference), GMP training gaps were stated as either the 5th, or 6th, most common reason for a GMP compliance failure in an Audit by the TGA or FDA.
The issues related to either inadequate GMP training, insufficient training of contractors and employees, or outdated employee GMP training (non-current training or no current training records).
Why is employee GMP training such a common failure point (and penalty area) during regulatory GMP inspections by the TGA or FDA, or other regulatory agencies?
Given the numerous GMP training options available, including e-learning options and blended training approaches for mandatory GMP training, the most common reasons for PICS/GMP audit failures relate to dynamic factors.
The following factors appear to intertwine to lead to serious gaps in training programs:
- Procrastination – we’ll train employees next month / next year / when we have spare time on the production line
- Turnover – employee turnover or being short-of-staff, especially during busy production time periods, e.g. not wanting to lose key employees for a day (and not realising self-paced e-learning GMP solutions are available for very low-cost training)
- Budget constraints and/or inadequate foresight when developing annual employee training and development budgets
- New products or equipment needing proper employee training for validation / or independent equipment validation consultancy
- Contractor orientation and GMP training gaps
- General oversight
- Poor record-keeping of employee training (something online training does seamlessly in terms of providing certificates immediately after GMP training assessments are completed/passed).
Snapshot: which GMP compliance areas are identified most frequently in audit failures during TGA or FDA inspections?
Here’s a snapshot of the most common TGA audit failures and/or FDA audit failures based on industry experience.
- Training gaps: Inadequate training or dated/non-current GMP training (poorly trained employees and contractors)
- Equipment problems: poorly maintained, contaminated equipment or not recently validated
- Validation and process control deficiencies: Quality management systems and operational processes weren’t recently validated/lack of continuous improvement
- CAPA failures: inadequate investigations to properly to investigate root causes; to resolve deviations, product failures and customer/patient complaints
- Labeling errors: failure of the Pharmaceutical Quality System to discern label problems before release
- Complaints handling: no recently updated complaints process, ill-trained employees, employee training for handling a mock recall was not implemented
- Management reviews: management QM reviews not conducted frequently enough based on risks and rules for at least an annual meeting (or more frequently depending on the product risks and safety, quality and efficacy concerns); and/or a lack of full management participation and meeting record-keeping
- Vendor management: not properly auditing your suppliers including transport and warehouse contractors
- Inadequate Quarantine procedures/storage: lack of updated SOPS or failure to follow appropriate SOPs, separation and labelling of quarantined materials not clear or improperly stored
- Recordkeeping gaps (GDocP and/or failure to train employees/keep records of training course completion)