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CHAPTER-1 DEFICIENCIES.pdf

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Dr. Dinesh Mehta
Dr. Dinesh Mehta

As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.

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CHAPTER-1 DEFICIENCIES OR RECORDING NONCONFORMITIES PREPARED BY DR DINESH KUMAR MEHTA MM COLLEGE OF PHARMACY, MM(DU), MULLANA
Nonconformities or deficiencies: As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity”. What is nonconformity?  A condition adverse to Quality.  The non-fulfillment of a requirement. The number of nonconformities that can arise during an audit can be numerous. Following types of defects are identified during an internal audit and these are helpful in regulatory compliance: There may be nonconformity for one of three reasons 1. The procedure or defined process does not conform to the regulatory requirements 2. The procedure or process has not been put into practice in the described way 3. The practice, what is actually done, is not effective (planned results not achieved) CLASSIFICATION OF DEFICIENCIES Critical defect:  Critical defects have a high probability of resulting in a product recall or in an adverse physiological response by the consumer.
 Critical deficiencies found in internal audits that usually produce significant effects on the strength, identity, safety, and purity of the product that will be considered during regulatory compliance. The possible source of a critical defect are:  Cross-contamination of materials of the product.  Incorrect labelling.  Active ingredients outside of specifications.  Product manufactured according to obsolete or unapproved procedures.  Open sterile products located in a non-aseptic area.  Untrained operators working in the sterile filling area.  Contaminated purified water or water for injection system. Major defect Major defects found during the internal audit can reduce the usability or stability of a product, but without causing harm to the consumer. The possible source of a major defect are:  Major equipment not calibrated or out of calibration.  Inadequate segregation of quarantine components.  Inadequate evaluation of production process outside of action levels.  Process deviations not properly documented or investigated.  Operator not trained in or familiar with the standard operating procedures.
 Preventive maintenance on a critical water system not conducted according to schedule.  Lack of standard operating procedures for cleaning equipment.  Audits of a contract manufacturer not conducted. Minor defect Minor defects have a low probability of affecting the quality or usability of the product which can help in regulatory compliance. Possible source of the minor defect are:  Failure to complete all batch record entries.  Warehouse not cleaned according to schedule  Cracks in wall surfaces.  Failures to correct documentation errors properly.  Operator uniform not properly worn.  Standard operating procedure review is overdue.  Adhesive tape used on manufacturing equipment.  Laboratory buffer solutions are obsolete.

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CHAPTER-1 DEFICIENCIES.pdf

  • 1. CHAPTER-1 DEFICIENCIES OR RECORDING NONCONFORMITIES PREPARED BY DR DINESH KUMAR MEHTA MM COLLEGE OF PHARMACY, MM(DU), MULLANA
  • 2. Nonconformities or deficiencies: As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity”. What is nonconformity?  A condition adverse to Quality.  The non-fulfillment of a requirement. The number of nonconformities that can arise during an audit can be numerous. Following types of defects are identified during an internal audit and these are helpful in regulatory compliance: There may be nonconformity for one of three reasons 1. The procedure or defined process does not conform to the regulatory requirements 2. The procedure or process has not been put into practice in the described way 3. The practice, what is actually done, is not effective (planned results not achieved) CLASSIFICATION OF DEFICIENCIES Critical defect:  Critical defects have a high probability of resulting in a product recall or in an adverse physiological response by the consumer.
  • 3.  Critical deficiencies found in internal audits that usually produce significant effects on the strength, identity, safety, and purity of the product that will be considered during regulatory compliance. The possible source of a critical defect are:  Cross-contamination of materials of the product.  Incorrect labelling.  Active ingredients outside of specifications.  Product manufactured according to obsolete or unapproved procedures.  Open sterile products located in a non-aseptic area.  Untrained operators working in the sterile filling area.  Contaminated purified water or water for injection system. Major defect Major defects found during the internal audit can reduce the usability or stability of a product, but without causing harm to the consumer. The possible source of a major defect are:  Major equipment not calibrated or out of calibration.  Inadequate segregation of quarantine components.  Inadequate evaluation of production process outside of action levels.  Process deviations not properly documented or investigated.  Operator not trained in or familiar with the standard operating procedures.
  • 4.  Preventive maintenance on a critical water system not conducted according to schedule.  Lack of standard operating procedures for cleaning equipment.  Audits of a contract manufacturer not conducted. Minor defect Minor defects have a low probability of affecting the quality or usability of the product which can help in regulatory compliance. Possible source of the minor defect are:  Failure to complete all batch record entries.  Warehouse not cleaned according to schedule  Cracks in wall surfaces.  Failures to correct documentation errors properly.  Operator uniform not properly worn.  Standard operating procedure review is overdue.  Adhesive tape used on manufacturing equipment.  Laboratory buffer solutions are obsolete.