Importance Of Self- Inspection And Quality Audits In Pharmaceutical Industry

Introduction:

Self-inspection is basically an objective method of overall operations itself on aspects that might have a quality effect on quality assurance. In general, self-inspection aims to identify defects whether critical, large or small properties. Self-inspection must be done by competent people who are appointed by the company. The self-inspection program is carried out to monitor the implementation and compliance with the current GMP principles and to ensure that the corrective actions needed are taken.

Purpose:

Self-inspection is a way to assess the entire operating system of each aspect that can affect product quality. This is not only to find weaknesses or errors but more important is to find ways to prevent and overcome problems effectively.

Self-inspection team:

The self-inspection team, of which members are appointed by the company's management, must initially prepare a checklist for self-inspection for reference in the implementation of inspection. The self-inspection team must be made from production, R&D, engineering, quality control, quality assurance and general department. The team must consist of technically expert people with a high conscience in quality assurance in drug product processing activities.

Coverage of self-inspection:

The self-inspection team have to learn carefully every point in GMP guidelines and drive questionnaires installed on the company's needs. The following items must undergo self-examination to ensure GMP in premises according to who requirements.

• Personnel
• Premises and equipment
• Maintenance
• Storage of Products from Start and finish product
• Production and in-process control
• Quality control
• Documentation
• Sanitation and Hygiene
• Validation and revalidation Programs
• Documentation process
• Complain and product recall
• Instruments calibration
• Label control
• The results of self-inspection and corrective actions are taken

Frequency of self - inspection:

Self-examination must be done at a reasonable interval but must cover the area / operation / function at least once a year or if necessary in a short interval.

We Rhombus Pharma Pvt.Ltd. follows self-inspection on every six months.

Procedure:

• Prepare the time schedule and area to be examined by yourself
• Determine the self-inspection team
• Prepare a checklist for self-inspection
• Record all fields
• Prepare reports and findings recommendations
• Distribute to the head of the department concerned
• Prepare a corrective action plan

Self-inspection report:

In the implementation of self-inspection, the team must be remembered consistently that the purpose of self-inspection is to find improvements and not only errors finding. The team also provides recommendations for resolving problems encountered by considering the economic aspects of GMP implementation.

Distribution Reports:

• Director of the plant
• Production manager
• Quality control manager
• Head of Engineering Department

Corrective action:

• Must be suitable for improving deficiencies
• Must prevent reoccurrence
• Must be resolved on time
• It must be documented and the records be maintained
• Must be monitored

Impact of Self-Inspection on PCD Pharma Franchise Company

We Rhombus Pharma Pvt Ltd. having own manufacturing facilities, we are performing self-inspection audit on regular interval of time to maintain uniform quality of product at each stage.