Zamann Pharma Support logo

Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Request an appointment now

How We Fixed Critical GMP Equipment Requalification Gaps for a Pharmaceutical Manufacturer

A German pharmaceutical manufacturer asked Zamann Pharma Support to strengthen its Equipment Qualification program.

The main issue was not IQ, OQ, PQ, URS, or traceability. Instead, the company treated qualification as a one-time activity:

There was no periodic review, requalification plan, or defined trigger for unscheduled requalification.

Some equipment had operated for 5–12 years without performance re-evaluation, despite software patches, component replacements, parameter changes, and new product types.

Therefore, the company could not consistently demonstrate that equipment remained qualified throughout its lifecycle.

Our team assessed the qualification lifecycle, identified hidden performance gaps, and defined a risk-based requalification approach.

Challenges Faced

A detailed GAP analysis in Quality Management Systems is essential for identifying process deficiencies effectively.
  • One-Time Qualification Approach: Equipment was treated as permanently qualified after IQ/OQ/PQ.
  • No Requalification Schedule: No defined timing or risk-based plan for reassessment.
  • Long Gaps Between Reviews: Some equipment went 5–12 years without performance checks.
  • Undetected Equipment Drift: Requalification revealed significant measurement and performance deviations.
  • Lifecycle Changes: Updates, repairs, maintenance, and new products could affect qualification status.
  • Regulatory Expectations: EMA and FDA expect continued lifecycle oversight of qualified equipment.
  • Weak Maintenance Linkage: Maintenance and calibration issues were not tied to qualification decisions.
  • QA and Product Risk: Poor qualification control could affect quality, sterilization, cleaning, and compliance.

Zamann Pharma Support’s Approach

  • Lifecycle Qualification Review:
    Our team assessed qualification as an ongoing lifecycle activity rather than a one-time project.
  • Targeted Requalification: Focused testing identified equipment performance issues that routine checks had missed.
  • Regulatory Review:
    The assessment considered EMA Annex 15, Annex 11, EU GMP expectations, FDA lifecycle control, and GAMP 5 principles cited in the source.
  • Requalification Self-Assessment: The program was evaluated against seven areas, including scheduling, risk-based intervals, PQ repetition, annual review, maintenance linkage, and software impact assessment.
  • Risk-Based Frequency: Frequency was based on equipment criticality, product impact, deviation history, maintenance trends, process variability, and regulatory expectations. High-risk systems may require annual PQ, while lower-risk equipment may be reviewed every 2–3 years with justification.
  • Unscheduled Requalification Triggers: Triggers included breakdowns, major repairs, critical component replacement, software upgrades, recurring deviations, and new products.
  • Maintenance and Calibration Integration: Calibration failures required impact assessment, evaluation of affected batches, and consideration of unscheduled requalification.
  • Annual Quality Review: The source recommends reviewing deviations, maintenance, calibration history, performance data, alarms, and operational changes.
  • Controlled Documentation: Requalification should include protocols, execution records, raw data, deviations, reports, and QA approval.

Results Achieved

  • Hidden Failures Identified: Targeted requalification revealed probe drift, flow deviations, mixing problems, autoclave changes, and altered software alarm behaviour.
  • Lifecycle Gap Identified: The assessment confirmed that initial qualification alone did not demonstrate continued control.
  • Regulatory Risk Clarified: Inspectors made clear that historical qualification data could not replace evidence of continued equipment control.
  • Equipment Risks Better Understood: The case linked performance drift to mixing, sterilization, environmental control, cleaning, and cross-contamination risks.
  • QA Requirements Clarified: Reliable qualification status supports batch approval, change control, deviation assessment, and inspection defence.
  • Requalification Strategy Defined: The source established a framework based on risk, periodic review, unscheduled triggers, maintenance signals, and controlled documentation.
  • Operational Benefits Identified: Strong lifecycle requalification supports fewer deviations, faster investigations, more predictable batch release, lower audit risk, reduced downtime, and improved equipment reliability.
Laboratory
GMP qualification and lifecycle validation activities including IQ, OQ, and PQ supporting inspection readiness in pharmaceutical manufacturing.
Services

Qualification and Validation for GMP Systems

Our team supports the planning, execution, and maintenance of qualification and validation activities, including IQ, OQ, and PQ, to keep GMP-regulated systems compliant and under control.

Read More

Contact Us

Need help? Don't hesitate to get in touch
Zamann pharma support is committed to protecting and respecting your privacy, and we’ll use your personal information to administer your account and to provide the products and services you requested from us.

FAQ

1. How often should GMP equipment undergo periodic requalification?

The source recommends a risk-based interval rather than a fixed schedule for all equipment.

Equipment criticality, product quality impact, deviation history, maintenance trends, calibration trends, and process variability should guide the decision.

High-risk equipment such as sterilizers, HVAC systems, and water systems may require annual PQ. Lower-risk equipment may be reviewed every 2–3 years, but the interval requires justification.

2. Should a software upgrade trigger unscheduled equipment requalification?

Software upgrades should be included in qualification impact assessments. The source also lists software upgrades as potential triggers for unscheduled requalification.

This is important because the case identified software updates that changed alarm behaviour. Therefore, software changes should not be separated from equipment lifecycle qualification decisions.

3. What should QA review before deciding whether GMP equipment remains qualified?

The source recommends reviewing deviations, maintenance records, calibration history, performance data, system alarms, and operational changes.

Calibration failures should also trigger an impact assessment. In addition, QA should consider whether unscheduled requalification is necessary.

This review helps determine whether the equipment remains in its qualified state or requires earlier requalification.