FDA & TGA GMP Compliance Audit Citations for 2020, 2021, & 2022.

Latest FDA inspection trends: common audit findings (2020-2022)

During the pandemic, manufacturers experienced unprecedented supply chain disruptions and product transport issues. Read more on APIs, medicines and medical device shortages related to the impact of the pandemic.

Impact of the pandemic on TGA and FDA audit findings/citations

With numerous shortages and increased product demand, Supplier Qualification and Supply Verification Programs (focusing on foreign suppliers) became one of the most important concerns during TGA or FDA inspections/audits. It tops the 2022 GMP audit citations list, at place number one.

The list below represents a snapshot of the most common GMP compliance audit findings (TGA audit failures/FDA audit failures) based on industry experience for the years 2020, 2021 and 2022.

TGA and FDA GMP audit citations

2022 Synopsis for Most Common FDA Audit Findings over recent years

  1. Supplier Verification Programs:  Failure to qualify suppliers and/or maintain appropriate supplier qualification records
  2. Deviations: Poor investigations, root cause analysis and CAPA planning.   
  3. Computerised systems validation and controls: Electronic systems for QMS processes not properly validated, data not backed up, lack of audit trails, inadequate procedures for access control.
  4. Validation: Inadequate cleaning validation, poor equipment qualification and poor process validation; lack of continuous improvement.
  5. Environmental controls: Inadequate environmental controls specified and frequency of environmental monitoring.
  6. Training gaps: Inadequate training or dated/non-current GMP training (poorly trained employees and contractors)
  7. CAPA failures: Inadequate root cause investigations and analysis to properly evaluate primary causes of deviations, product failures and customer/patient complaints; and inadequate CAPA systems
  8. Labelling errors: Failure of the Pharmaceutical Quality System to discern label problems before release.
  9. Complaint handling: No recently updated complaints process, inadequately trained employees; employee training for handling a mock recall was not implemented.
  10. Management reviews: Quality Management Reviews were not conducted frequently enough based on risks (or there was a lack of full management participation and inadequate Management Review Meeting recordkeeping):
    – GMP requires at least an Annual Management Review meeting
    –  But these must be held more frequently if appropriate based on product risks (product profile/risk classification, and other factors

Common GMP audit findings linked with the top 10 GMP citations/audit findings listed above included:

  • Recordkeeping gaps: Failure to train employees in good recordkeeping practice, lack of data system security measures, and/or failure to keep adequate training records, raw material testing records, batch records, etc.
  • Data integrity issues: inadequate data governance measures and data security controls
Note also, that the risks of misbranded and/or counterfeit products rose exponentially during the SARS-CoV-2 pandemic years.

Post-marketing surveillance (Pharmacovigilance), Good Warehouse Practice (GWP), and Good Distribution Practice (GDP) also needed to be further prioritised in the wake of the pandemic.

Audit Response Resources

Below are links to several important GMP training courses to help you keep your training programs up-to-date before your audit.

Preparing for a GMP audit by TGA or FDA Inspectors can be a time for introspection. Upcoming audits sometimes lead to initiating a continuous improvement plan, perhaps discussed for some time, but not yet implemented. That’s because GMP audit preparations generally bring decisive actions and resources to lingering compliance issues, rather than endless discussions. Examples include:

On the positive side, an upcoming TGA or FDA GMP audit can bring forward positive improvements that were pending (where such improvements were properly evaluated and planned).  

But GMP compliance audits can also feel stressful.

TGA & FDA audits can be a particularly stressful time for Quality Management Teams, Risk Management Personnel, and other employees responsible for ensuring GMP compliance during all processes of their operations, and throughout the product’s entire life cycle.

GMP Audits & Site Inspection Stress

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.

tga-inspection-GMP-audit-fda-inspection-failure

  • That’s because, despite knowing you should be ready for an inspection at any time, you’re aware that some (or perhaps all) of your documents, validation schedules, training records, CAPAs, and other quality records or systems have gaps.
  • Sometimes, lingering compliance concerns can 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, personnel absenteeism or turnover around auditing times is not uncommon.
  • With management ultimately responsible, this leaves the organisation even more exposed to compliance notices, penalties/fines, and potential shutdowns.

Stressed about an upcoming TGA or FDA Inspection/GMP Compliance Audit?

  • One way to reduce the stress of an upcoming Regulatory Compliance Inspection/GMP Audit is through self-inspections.
  • Another way is by initiating continuous improvement initiatives.
  • These types of actions show Regulatory Authorities that you are working through compliance concerns, such as recurring deviations & non-conformance issues.

Even these measures, however, require you to start with one of the most basic tenets of GMP (Good Manufacturing Practice): GMP compliance training, such as:

Lagging self-inspections for GMP compliance

Another common issue that keeps Quality Teams up at night is a ‘pushed back’ self-inspection schedule. It’s understandable to be fearful of ‘what you might find’ during a self-inspection or outsourced compliance audit. It’s also possible urgent priorities can ‘get in the way’ of a labour-intensive self-inspection program.

But being afraid to look at your compliance issues — or being shy on time to conduct self-inspections — means there’s typically a higher price to pay at audit time.

Remember, expert help is available for GMP Compliance Audit preparations & Self-inspections

Need help with audit preparation? Options include:

Self-inspections and TGA or FDA GMP Audit Citations

PIC/S GMP Audits and Self-Inspection Processes
  • Conducting regular self-inspections (and checking your GMP training records) are excellent ways to reduce the risks of citations during a TGA or FDA inspection.
  • Self-inspections help you to assess the status and effectiveness of your Pharmaceutical Quality System (PQS) or Quality Management System (QMS).
  • Conducting self-inspections or 3rd-party Audits will generally help you to:
    • Better understand any operational problems & non-compliance issues
    • Bring to light any validation-related issues and/or seek expert validation support
    • Dig deeper to determine the root cause(s) of recurring issues
    • Assess effective solutions for quality-related issues such as product complaints
    • Provide evidence that you’re working on process issues and quality system gaps that could have an impact on the safety, quality, and efficacy of your pharmaceutical products and/or medical devices.

Self-inspection schedules: the importance of staying on track

We understand that GMP compliance audits by Regulatory Authorities, and regular self-inspections, can be time-consuming, resource-intensive, and daunting in terms of what you discover needs refinement.

Yet remaining determined to stay on track is imperative. Here’s why:

  • Self-inspection delays can lead to experiencing GMP audit findings/citations from the TGA, FDA, and other Regulatory Authorities.
  • Delays in performing self-inspections or 3rd-party audits could result in costly product recalls.
  • Delays in self-inspections (fearing what you don’t know) often lead to skyrocketing ‘pre-audit stress’ levels.
  • Recognising, documenting and taking action will help you regain some sense of control and progress.

Failing to review your quality system and perform thorough self-inspections — including of your CAPA system and complaints management systems — is why the ‘top 10 GMP compliance audit citations’ (listed below for 2021-2022) are so prevalent.

  • It’s not uncommon to experience lags in self-inspection schedules, but this can be prevented.
  • Getting external audit preparation and audit response support from GMP consultants can generally help reduce self-inspection schedule gaps and reduce your risk of GMP audit citations, and can be a worthwhile investment (and audit stress-reduction strategy).

Shy on time?

Self-inspections can typically be outsourced to a 3rd-party GMP compliance auditor.

This can save you heartaches — headaches — as well as reduce your risks of audit citations, product recalls, or production shut-downs, over time.

Why do self-inspection schedules lag?

And why are GMP compliance audits stressful?
  • Similar to ongoing GMP training program gaps discussed below, the issue is generally two-fold and involves the following resources/priorities:
    • Time-management
    • Budget-management 

Both resources — time (dedication of labour) and budget (dedication of other resources) — require prioritisation. That’s because these are the pivotal components that underpin all other GMP compliance activities.

Another pivotal GMP component that takes time and resources is GMP compliance training.

GMP personnel must be educated in GMP, GxP,  product-specific regulatory requirements, and site-specific procedures. They should also, ideally, be thoroughly trained in handling GMP audits by Authorities (audit preparation training) and ‘recall preparedness’.

Read the article: Are you recall ready according to the FDA?

Training personnel: Audit preparation strategies

Training GMP personnel to be ‘audit ready’ takes management commitment, strategic scheduling, and GMP education resources. It requires ongoing monitoring of roles, responsibilities, and training program completion.

  • You can’t expect personnel to fulfil their GMP responsibilities if they’re not up-to-date with current PIC/S GMP compliance requirements (or other relevant standards).
  • Failure to provide appropriate or ongoing GMP compliance training is frequently in the top 10 GMP audit citations list (usually 5th or 6th place).
  • Scroll down for the FDA’s and TGA’s ‘top 10 citation reasons’ for 2021-2022.

Prior to the pandemic, GMP training gaps often held 1st or 2nd place in terms of GMP deficiencies identified during audits by FDA Inspectors, TGA Inspectors, and other Regulatory Authority representatives.

Even today, when supplier programs are near the top of the ‘top 10’ FDA & TGA audit citations, gaps in GMP training programs remain in the ‘top 10’ most frequently cited GMP compliance deficiencies.

The same is true for suppliers, contractors, maintenance, and distribution teams.

  • Suppliers and contractors cannot be expected to comply with GMP if they do not have adequate, ongoing GMP compliance training.
  • TGA Inspectors/FDA Inspectors recognise that appropriate GMP training of all involved parties is pivotal to creating a GMP-compliant culture

Regulatory Authorities generally investigate your employee files, supplier files, and training records to assess Management’s commitment to GMP compliance, and to the Training & Development of operations personnel.

So, what should you do before an audit if you fear being cited for gaps in your GMP compliance training program/s?

  • If your company has gaps in compliance training, particularly if you had high turnover during the pandemic, you can start by auditing your training and development records using self-inspection strategies (internal audits).
  • When you do find gaps in your compliance training programs, document them all and categorise them according to which employees need which GMP training topics.
  • Then set about scheduling your sessions; considering the value of implementing eLearning courses, as part of a blended-learning solution.
  • Benefits of eLearning GMP courses include:
    • They are easily organised for your team;
    • They are immediately accessible (24/7); and
    • They include a Certificate of Completion for your personnel training records (GMP training program files).
  • There are also Zoom-based GMP compliance courses, onsite training (where available), as well as online GMP training — all of which can help you reduce your current GMP training gaps in an economical way.

top-10-citations-gmp-audits-responses-fda-tga

Common TGA or FDA Citations: 2022 Synopsis (post-pandemic analysis)

  • What were some of the ‘GMP audit findings’ (TGA & FDA citation trends) since the pandemic began?
  • Which areas of GMP non-compliance resulted in costly fines and other penalties such as operational shutdowns, recalls, and/or legal liability issues?

GMP Compliance Training Program gaps continue to be one of the top 10 reasons for citations issued during inspections/compliance audits by the TGA and FDA.

Training-related citations (examples): inadequate GMP training for personnel; insufficient training of contractors and employees; outdated training documentation; failure to maintain training records including for product-specific training, lack of recall training; and similar issues.

Why are employee training programs for GMP compliance so commonly cited during audits?

Given the many Good Manufacturing training options available, the reason training programs are frequently cited during GMP compliance audits relates more to the dynamic between multiple factors, rather than to one specific reason.

These factors include:

  • Procrastination – “We’ll train employees next month, next year, when we have spare time on the production line, when they’re all in the same place at once….etc.”
  • Turnover – Employee turnover and/or being short-staffed (especially during busy production periods) can lead to short-term objectives being prioritised over training attendance (not wanting to lose key employees for a day; not realising 24/7 e-learning solutions can fill compliance training gaps with minimal impact on production schedules)
  • Budget constraints/inadequate foresight – when developing annual employee training and development budgets
  • New products or equipment – Needing revisions to employee training materials and program content; needing validation (equipment validation consultancy)
  • Orientation training gaps – Contractors and maintenance workers are not adequately briefed/trained on GMP requirements
  • General oversight or poor recordkeeping – Failure to keep abreast of training schedules and training needs including for new and longer-term employees (online GMP training does this seamlessly, with 24/7 self-paced course access, and GMP Course Completion Certificates immediately available after successful completion of the online assessment.

Changes in TGA Audit and FDA Audit citations & warning letters from preceding years

GMP audit citations: pre-pandemic (2018-19)

What were the most frequently cited GMP compliance gaps before the impact of the pandemic on supply chains?

What were the common findings of FDA GMP Compliance Audits and/or TGA GMP audit audits, prior to the pandemic (e.g. 2018 and 2019), compared to the items listed at the top of this blog?

2018 to 2019 GMP AUDIT CITATIONS

Snapshot of pre-pandemic GMP audit citation trends

Here’s a snapshot of the most common TGA citations and/or FDA citations, based on industry experience, during 2018 and 2019 (pre-pandemic).

  1. Training gaps: Inadequate training or dated/non-current GMP training (poorly trained employees and contractors)
  2. Equipment problems: poorly maintained, contaminated equipment or not recently validated
  3. Validation and process control deficiencies:  Quality management systems and operational processes weren’t recently validated/lack of continuous improvement
  4. CAPA failures: inadequate investigations to properly to investigate root causes; to resolve deviations, product failures and customer/patient complaints
  5. Labelling errors: failure of the Pharmaceutical Quality System to discern label problems before release
  6. Complaints handling: no recently updated complaints process, ill-trained employees, employee training for handling a mock recall was not implemented
  7. Management reviews: management QM reviews were 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
  8. Vendor management: not properly auditing your suppliers including transport and warehouse contractors
  9. 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
  10. Recordkeeping gaps (GDocP and/or failure to train employees/keep records of training course completion)

Visit the online GMP training packages and GMP assessment store.

GMP e-learning and online GMP assessments - training packages

Recommended reading:

FDA Audit Responses: Resources

Last updated on July 6th, 2023 at 10:26 am

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