Non conformity

A non conformity is a failure of unit/ instrument to confirm to specific requirement. A non- conformity observed in pharmaceuticals is classified into three different categories.

Critical non-conformity: A critical non-conformity is one that can affect the quality and safety of the product, and may cause harm to the patients if administered. Such non-conformities would include mix-ups, mislabeling or release of products where the potency is grossly above or below the labeled amounts. A critical non-conformity will lead to the manufacturer being given an “Unacceptable” GMP compliance rating.

Major non-conformity: A major non-conformity is one that may affect the quality and safety of the product, and includes unauthorized process changes, invalidated manufacturing processes that have a major impact on quality, e.g. failure to record any system suitability or calibration failure on equipment (where sample or product has been run) etc.

Minor non-conformity: A minor non-conformity is not likely to affect the quality and safety of the product. These include deficiencies arising out of lapses in discipline e.g. failure to review an SOP at the due date, using correction fluids to amend records, failure to record any system suitability or calibration failure on equipment (where no sample or product has been run) etc.

Share This Post

Recent Articles

© 2024 Pharmaceuticals Index. All rights reserved.