Internal Audit Of Pharmaceutical Plant

QA SOPS

1.   PURPOSE

This document describes the conduct of internal audits to assure cGMP system and is effectively implemented.

2.   Objective

To Provide a Documented Procedure for review of the quality system for GMP Conformance Certification, including the conduct of an internal audit to assure the system meets the requirements.

3.     SCOPE

To define the role/responsibility of various functions responsible for internal audit

4.    RESPONSIBILITY

QA Internal Auditor(s):

QA Manager.

5.   PROCEDURE

Critical, major, and minor defects found during an internal audit in Pharmaceuticals and self-inspection compliance checklist.

The following types of defects were identified during an internal audit and these are helpful in regulatory compliance:

5.1          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.

5.1.1       Possible source of critical defect:

  •  Cross-contamination of materials (Raw materials both API and excipients)  of the product
  •  Incorrect labeling
  •  Active ingredients (API) outside of specifications
  •  Product manufactured according to obsolete or unapproved procedures
  •  Open sterile products located in a non-aseptic area
  •  Untrained operators workers working in the sterile filling area
  •  Contaminated purified water or water for the injection system(wifi).

5.2           Major defect:

Major defects found during an internal audit can reduce the usability or stability of a product, but without causing harm to the consumer.

5.2.1       Possible source of major defect:

  •  Major equipment not properly 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/workers  not trained in or familiar with the standard operating procedures
  •  Preventive maintenance on a critical water system not conducted according to schedule.
  • Nonavailability of standard operating procedures for cleaning equipment.

5.3           Minor defect:

Minor defects have a low probability of affecting the quality or usability of the product which can help in regulatory compliance.

5.3.1       Possible source of minor defect:

  •  Failure to complete all batch record entries(BMR).
  •  Warehouse/Store not cleaned according to schedule
  •  Cracks in wall surfaces
  •  Failures to correct documentation errors properly
  •  Operator/workers  uniform not properly is worn
  •  Standard operating procedure review is overdue or missing.
  •   The adhesive tape used on manufacturing equipment
  •   QC Laboratory reagents, solution, buffer solutions are expired.

 

PROCEDURE:

  • An Internal Audit of the individual departments is carried out once in three months. The

audit team comprises of QA, Officer, Concerned department head and.

Basically the audit is to find out critical, Major, minor defects, nonconformances  and unsafe conditions in the department and to comply the same.

 

  • Apart from schedule internal audit, the QA officer takes daily round covering all

departments and the critical findings are highlighted to the concerned

department and for rectification through an internal memo.

 

  • Findings, nonconformities, trends, and other opportunities for improvement are identified; investigated to determine the causes, and corrective/preventive actions are developed. These actions are implemented as soon as possible and recorded

 

Frequency: The internal audit must be conducted at least every 3 months.

5.4   Safety Audit:

PROCEDURE:

The Safety Audit of the individual department is carried out once in three months. The

audit team comprises of QA, Officer, Concerned department head, and

maintenance Officer. Basically the audit is to find out unsafe acts and

unsafe conditions in the department and to comply the same.

 

Apart from schedule safety audit, the QA officer takes daily round covering all

departments and the critical findings are highlighted to the concerned

department and for rectification through an internal memo.