PDA Technical Glossary
Home / PDA Technical Glossary

PDA Technical Glossary

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the  PDA Technical Report Portal.

(Please select "All" to restart a filtered Search)

  • All
  • 0
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z
TR 43: Glass Defects N
Nonconformity (ANSI def.)
A departure of a quality characteristic from its intended level or state that occurs with severity sufficient to cause an associated product or service not to meet a specification requirement. [Synonym: Defect] (TR43)(TR76)
Source:
Nonconformity (ISO def.)
A condition of any product or component in which one or more characteristics do not conform to requirements. Includes failures, deficiencies, defects, and malfunctions. [Synonym: Defect](TR43)(TR76)
Source:
Nonconformity Classifications
Critical: A Nonconformity that is likely to result in personal injury or potential hazard to the patient. This classification includes any nonconformity that compromises the integrity of the container, and risks microbiological contamination of a sterile product. Major A: A Nonconformity leading to serious impairments, for example, a malfunction that makes the packaging unusable. Major B: A Nonconformity leading to impairments of a lesser degree, for example, reduced efficiency in production. Minor: A Nonconformity that does not impact product quality or process capability. N/A: An imperfection classification that is less than the size, magnitude and impact of a nonconformity is considered not applicable. Therefore an imperfection that is considered to be non-applicable is acceptable.(TR43) Critical: A nonconformity that risks personal injury or potential hazard to the patient. Any nonconformity that risks container closure in¬tegrity is assigned to this classification. Major A: A nonconformity leading to serious container impairments, e.g., a malfunction making packaging unusable. Major B: A nonconformity leading to contain¬er impairments of a lesser degree, e.g., reduced efficiency in production. Minor: A nonconformity that does not impact product quality or process capability. N/A: Imperfections that are considered to be nonapplicable or nondefects and are therefore acceptable.(TR 76)
Source: