Pharma industry and NCs

In the pharmaceutical industry, non-conformance refers to any deviation or failure to meet regulatory requirements, quality standards, or established procedures.

The following are some common types of non-conformances that can occur in the pharmaceutical industry:

• Deviation: Any departure from standard operating procedures, including manufacturing, testing, packaging, or labeling processes, which may affect product quality such as equipment malfunction, change in approved vendor for API/excipients, change in BOM or equipment list used for an approved batch.
• Out of Specification (OOS): OOS refers to results that fall outside the predefined specifications or acceptance criteria for a product, process, or test method such as variability in the physical or chemical properties of the drug substance or drug product, Inconsistency in the potency, desired drug release profile, impurities etc.
• Out of Trend (OOT): OOT refers to a trend of results that are moving away from the expected range or historical data, indicating a potential problem in the process or product quality.
• Market Complaints: Any reported issue related to a product quality, efficacy, or safety by a customer, patient, or healthcare professional such as such as broken tablets, missing or incorrect labels, or incorrect dosing instructions or problems with the drug delivery device (Combination drugs).
• Product Recalls: A product recall is initiated when a potential quality issue is identified that could pose a risk to patient safety, health, or welfare.
• Adverse events: Any unwanted or unexpected medical occurrence associated with the use of a product, including side effects, reactions, and allergies.
• Audit Observations: Any observations or non-compliance identified during an internal or external audit, inspection, or regulatory assessment.

It is crucial for pharmaceutical companies to have a robust non-conformance management system in place to identify, investigate, and correct any deviations from quality standards, regulatory requirements, or established procedures to ensure patient safety and product quality.

For more details on NCs in medical industry, stay tuned/visit for our next blog.