In a pharmaceutical manufacturing facility, Quality Assurance (QA) and In-Process Quality Assurance (IPQA) play a critical role in maintaining GMP compliance and ensuring that manufacturing processes consistently operate in a controlled state.
QA/IPQA personnel are often present at the interface between written procedures and actual shop-floor practices. Their routine responsibilities may include batch record review, line clearance, in-process verification, deviation management, change control, documentation review, training compliance, environmental/facility monitoring, and continuous shop-floor oversight.
Because of this, even a seemingly minor lapse in routine QA/IPQA activities can become an audit observation when it indicates a weakness in the pharmaceutical quality system.
The purpose of this article is to highlight some of the common QA/IPQA mistakes that auditors frequently look for during GMP inspections and internal audits.
1. Incomplete or Inadequate BMR/BPR Review
Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) provide the documented history of how a batch was manufactured and packaged.
One of the common weaknesses is treating batch record review as a tick-and-sign activity rather than a critical GMP review.
Common mistakes include:
- Missing signatures or dates
- Unreviewed fields
- Failure to verify critical process parameters
- Missing entries
- Incomplete reconciliation
- Not reviewing attached records
- Failure to assess documented changes or corrections
- Overlooking discrepancies between different sections of the batch record
Why can auditors notice this?
An auditor may select a batch record and compare it with:
- Equipment logbooks
- Dispensing records
- IPC results
- QC results
- Cleaning records
- Calibration records
- Electronic data
- Deviation records
If these records do not tell the same story, questions about batch traceability and data integrity can arise.
Good practice
QA should conduct a systematic, risk-based review rather than merely checking whether all boxes are ticked.
2. Line Clearance: “Paper Clearance” Instead of Physical Verification
Line clearance is one of the areas where relatively small mistakes can create significant GMP risks.
A common weakness is completing the line-clearance checklist without adequately verifying the physical area.
Typical issues:
- Previous product remnants
- Previous batch documents
- Old labels or packaging components
- Unremoved materials
- Inadequate equipment cleaning
- Incorrect status labels
- Incomplete line-clearance documentation
An auditor may ask a very simple question:
“Show me how you verified this area was actually clear.”
If the answer is only a completed checklist, without adequate evidence of physical verification, it can become an observation.
Good practice
QA/IPQA should physically verify the area and equipment, confirm the required clearance points, and ensure that the documented record accurately reflects what was actually checked.
3. Missed or Incorrect In-Process Checks
IPQA is expected to provide effective oversight of manufacturing processes.
Common issues include:
- IPC not performed at the specified frequency
- Incorrect sampling
- Incomplete recording
- Recording results retrospectively
- Failure to review abnormal trends
- Failure to escalate deviations
- Continuing operations despite unresolved issues
The purpose of IPC is not simply to generate numbers.
It is to provide real-time assurance that the process remains within established controls.
A missed IPC can therefore represent more than a documentation error—it may indicate that the process was not adequately monitored.
4. Deviation Management Weaknesses
Another area frequently examined during audits is the organization's deviation management system.
Common QA/IPQA mistakes:
- Failure to identify a deviation
- Delayed reporting
- Inadequate initial assessment
- Weak root-cause analysis
- Copy-paste investigation conclusions
- CAPA that does not address the actual root cause
- Failure to assess recurrence
- CAPA effectiveness not properly evaluated
A recurring problem should not simply generate another deviation with the same explanation.
The key question is:
“Why did the existing controls fail to prevent or detect this problem?”
A strong investigation should consider system, process, equipment, personnel, procedure and environmental factors, as applicable.
5. Change Control: Work Started Before Approval
Change control is another area where routine operational pressure can create compliance problems.
Examples include:
- Implementing a change before formal approval
- Inadequate impact assessment
- Failure to involve relevant departments
- Poor documentation
- Not assessing validation implications
- Not assessing regulatory impact
- Not evaluating the effect on the established/validated state
One of the most serious principles is:
Approval should precede implementation where the applicable change-control procedure requires it.
“Temporary” or “urgent” changes should still be managed through the applicable approved process rather than becoming undocumented permanent practices.
6. Investigation and Trend Review Gaps
QA should not only investigate individual events—it should also look for patterns and recurring signals.
For example:
- Repeated deviations
- Recurring equipment failures
- Repeated IPC failures
- Similar market complaints
- Repeated environmental excursions
- Recurring OOS/OOT events
- Repeated documentation errors
Individually, each event might appear minor.
Collectively, however, they may indicate a systemic problem.
Good QA practice
Regular trend analysis should ask:
Are we seeing the same problem repeatedly?
If yes, the organization may need a more comprehensive investigation rather than isolated CAPAs.
7. Obsolete or Uncontrolled Documents on the Shop Floor
Document control problems are classic audit findings.
Examples include:
- Obsolete SOP copies
- Uncontrolled photocopies
- Missing current SOPs
- Personnel following an outdated instruction
- Incorrect revision displayed at the workplace
- Failure to remove superseded documents
An auditor may compare the document being used by an operator with the current approved version in the document-management system.
If they do not match, the organization may have a significant GMP concern.
QA/IPQA responsibility
Routine shop-floor checks should verify that personnel have access to and are using current, approved documents.
8. Training and Qualification Gaps
A procedure is only effective if the person performing the activity is appropriately trained and qualified.
Common gaps include:
- Training not completed before performing the activity
- Expired or incomplete training
- Missing training records
- Personnel performing tasks without documented qualification
- Inadequate assessment of training effectiveness
- Training completed but competency not demonstrated
A common mistake is assuming:
“The person attended training, therefore the person is competent.”
Training attendance and demonstrated competency are not always the same thing.
For critical activities, the organization should have appropriate mechanisms to establish that personnel are trained and qualified for the task they perform, according to applicable procedures.
9. Facility, Environmental and Utility Monitoring Gaps
QA/IPQA oversight can extend to facility and environmental conditions relevant to product quality.
Potential weaknesses include:
- Failure to review temperature/RH records
- Ignoring HVAC alarms
- Inadequate response to excursions
- Environmental monitoring results not appropriately reviewed
- Failure to investigate abnormal trends
- Poor documentation of corrective action
- Not assessing product impact after an excursion
The important point is that an alarm or excursion should not simply be acknowledged and forgotten.
The event should be assessed according to the applicable procedure and risk to product/process quality.
10. QA/IPQA Presence on the Shop Floor
Perhaps one of the most important areas is the actual effectiveness of QA/IPQA presence.
QA/IPQA should not become merely a “document review department.”
Effective shop-floor oversight means:
Observe → Verify → Question → Assess → Document → Follow up
A QA/IPQA professional should be able to recognize when actual practice differs from the approved procedure.
For example:
- Operator following an outdated practice
- Unapproved temporary arrangement
- Improper material identification
- Missing status labels
- Unusual equipment condition
- Improper documentation practice
- Process being performed differently from the SOP
An auditor may observe the operation directly and then ask QA:
“Is this practice permitted by your procedure?”
If the actual practice and the documented procedure do not match, the organization needs to understand why.
Why Do These Errors Keep Appearing?
Many organizations respond to every mistake with:
“Retrain the person.”
Training is important, but it is not always the complete solution.
A better investigation should ask whether the underlying cause involves:
- Poor SOP design
- Complex documentation
- Inadequate supervision
- Weak procedural controls
- Poor communication
- Equipment design
- Inadequate automation
- Workload or staffing
- Inadequate qualification
- Weak quality culture
- Ineffective previous CAPA
If the system allows the same mistake to happen repeatedly, retraining alone may not prevent recurrence.
What Does an Auditor Really Look For?
During a GMP audit, an auditor may not only look at whether a document exists.
They may ask whether the document, actual practice and generated data all tell the same story.
For example:
That difference between “what is written” and “what actually happens” can be much more significant than a simple documentation mistake.
Therefore, QA/IPQA should continuously verify the alignment between:
Procedure → Practice → Record → Data → Outcome
When all five are consistent, the quality system becomes much more robust.
From “Audit Readiness” to “Inspection Readiness”
A strong pharmaceutical organization should not prepare for an audit only when an auditor announces a visit.
The plant should ideally remain inspection-ready every day.
That means:
- Current SOPs are available
- Personnel are appropriately trained
- Records are complete and contemporaneous
- Deviations are properly investigated
- CAPAs address root causes
- Change controls are implemented appropriately
- Data remains attributable and traceable
- Shop-floor practices match approved procedures
- Trends are actively reviewed
- Recurring problems are proactively addressed
The ultimate goal is not to “pass the audit.”
The goal is to have a robust pharmaceutical quality system that can withstand an audit at any time.
Final Thought
QA/IPQA is often described as the guardian of GMP compliance.
But being a good QA/IPQA professional is not about finding the maximum number of mistakes in Production.
It is about identifying risks before they become failures, detecting weaknesses before an auditor detects them, and improving the system so that errors do not recur.
A strong QA/IPQA team should be able to answer three questions at any time:
What can go wrong?How will we detect it?How are we preventing it from happening again?
Small Lapses. Big Audit Findings.
Do not wait for an auditor to identify the gap. Identify it yourself first.
About Pharmatext
Pharmatext is focused on sharing practical knowledge and awareness related to Pharmaceutical Manufacturing, QA, QC, GMP, Regulatory Affairs, Data Integrity, Compliance and Pharmaceutical Quality Systems.
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Note: The examples discussed above are general GMP-awareness examples. The exact regulatory expectation should always be assessed against the current applicable regulations, guidance, approved site procedures and specific product/process requirements.
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