Packaging Quality Systems: Preventing the Audit Leak

Whether for a fresh startup or a seasoned medical device manufacturer (MDM), it is an outright necessity to ensure that packaging quality systems provide for a stringent operating environment that effectively mitigates the three tiers of risks: patient, compliance, and business. And for challenging such stringency, audits exist. Some may view audits, internal and external, as strenuous events, while others may opine about them as robustness tests. 

Abhishek Gautam

Nevertheless, audits may lead to warnings/citations, which can transpire because of numerous reasons, namely upper-level-department strategy, lower-level execution, misalignment with ISO standards, misinterpretation of ISO standards, internal procedural compliance, documentation error, missing procedures, missing or incomplete validations, and many more to count.

The following list, while obviously not an all-inclusive one, comprises commonly reviewed and cited areas of scrutiny within the packaging engineering domain. All of such guidance can be related to ISO 13485, Part 820 of CFR Title 21, and ISO 11607: 1&2.

  • Packaging engineering training plans and training compliance
  • Packaging quality system procedures to govern (not all inclusive list)
    • Packaging drawing specifications
    • Packaging and equipment supplier selection
    • Supplier process validations
    • Packaging design and development (material requirements, design requirements, equipment requirements, etc.)
    • Test sample size calculation
    • Packaging test methods (visual inspection, seal strength testing, integrity testing, etc.)
    • Packaging test method validations (design and process)
    • Packaging seal process validations (IQ, DOE, OQ, PQ)
    • Packaging design verification (packaging distribution/shipment testing)
    • Packaging shelf life stability
  •  Packaging lab
    • Procedure to govern all lab activities
    • Packaging test equipment and related validations (IQ, OQ, TMV)
    • Packaging lab test request procedures and how lab test requests are processed
    • Lab record retention (test requests, test data sheets etc.)
    • Good documentation practices
    • Good lab practices
    • Safety areas (eyes, sounds, skin etc.)
    • MSDS sheets if needed
    • Calibration of instruments
    • Preventive maintenance
    • Training compliance
    • Procedural compliance
  • Supplier process validation documents for preformed sterile barrier packaging components (pouches, trays, etc.) (If not in existence, then these need to be completed.)
    • Installation qualification (IQ) of packaging equipment
    • Process validation of material on packaging equipment (e.g., OQ & PQ)
    • Mold qualification (if applicable, e.g., tray molds, can be combined with above)
  • Packaging specifications (drawings) – sterile and non-sterile components
    • Alignment with supplier requirements and capabilities
    • Alignment with supplier process tolerances
    • Alignment with receiving inspection measurement methods
  • Packaging test equipment validation documents– IQ, OQ, PQ
  • Packaging test method (visual, seal integrity, and seal strength) validations (e.g., Gage R&R, attribute Gage R&R, etc.)
  • Packaging sealing equipment validation documents – FAT (new equipment only), IQ, process development (DOE), OQ, and PQ
  • Packaging sealing process monitoring test methods and related validations
  • Packaging design verification (performance/shipment/transportation Testing)
  • Packaging sterilization validation and material compatibility (at times handled by Microbiology department or outsourced)
  • Packaging Shelf Life Stability Documents (Accelerated and Real Time Aging Testing)
  • Manufacturing packaging assembly procedure development, implementation and training
  • DFMEA and PFMEA (separate or as part of product FMEA)

My intent was to provide with a simplified list of requirements in guidance from some of major standards use by medical device industry. Obviously, the setting up and operations of business-specific packaging quality system is subjective to industry sector and classification of medical devices.

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By Abhishek Gautam, Packaging R&D Manager, ConMed

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