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Appearance Evaluation of Parenteral Pharmaceutical Products

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Sterile Product Development

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 6))

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Abstract

This chapter will describe the current state of the art and expectations of performing inspections of drug product with a focus on those defects that are visible to the eye. Visible attributes cover cosmetic and functional defects using both manual and automated techniques that use appearance as the key characteristic. The section will cover inspection attributes, compare and contrast manual and machine-based inspection with regulatory expectations, limitations, technologies, and provide several examples through case studies.

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Author information

Authors and Affiliations

  1. Drug Product Engineering, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA

    Erwin Freund

Authors
  1. Erwin Freund
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Corresponding author

Correspondence to Erwin Freund .

Editor information

Editors and Affiliations

  1. Pharmaceutical R&D-BioTx Pharmaceutical, Chesterfield, Missouri, USA

    Parag Kolhe

  2. LifeCell Corporation, Bridgewater, New Jersey, USA

    Mrinal Shah

  3. Drug Product Engineering, Amgen, Thousand Oaks, California, USA

    Nitin Rathore

Appendix: Inspection Attributes

Appendix: Inspection Attributes

  1. 1.

    Cosmetic

    1. (a)

      Surface scratches

    2. (b)

      Minor defects of the closures or label appearance

    3. (c)

      Major to critical defects of same

  2. 2.

    Content

    1. (a)

      Liquid:

      • Fill volume or weight

      • Observable matter as insoluble particles

      • Color: e.g., slightly pink or yellow

      • Clarity or degree of turbidity

    2. (b)

      Solid or Lyo cake:

      • Cracks

      • Collapse, shrinkage, etc.

      • Powder deposits above the cake

  3. 3.

    Functional

    1. (a)

      Attributes related to handling, proper dosing, sterility, and stability

      • CCI: defects such as cracks, vial crimp, etc.

      • Container/closure and component shape dimensions

      • Bent needles, needle shields, needle tip/hook, etc.

      • Graduation marks

      • Medical devices—scope can include injection aids such as an injection pen

      • Opacity of container material or overwrap used as sometimes the contents are light or oxygen sensitive

  4. 4.

    Labeling, bar codes, etc. for accuracy, format, color, readability, etc.

    1. (a)

      Text, artwork, 1 and 2 dimensional bar or QR codes

    2. (b)

      Package inserts or leaflets

    3. (c)

      Brand security anti-tampering and anticounterfeiting

    4. (d)

      Braille format embossing for products sold in the EU member states

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© 2013 American Association of Pharmaceutical Scientists

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Freund, E. (2013). Appearance Evaluation of Parenteral Pharmaceutical Products. In: Kolhe, P., Shah, M., Rathore, N. (eds) Sterile Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 6. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7978-9_15

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