Quality audits involve the systematic and independent examination of quality activities and processes to determine compliance with established standards. They can be internal or external. The presented document discusses the definition, purpose, types, procedures, and important aspects of quality audits for pharmaceutical companies. It provides an overview of audit planning, conducting audits, common difficulties found, and essential features of audit reports. The goal is to evaluate procedures, records, and operations to ensure they meet quality goals and identify any non-compliances or deficiencies.

1. Quality Audit
Presentation by
Miss Utkarsha Sukhdev Shivsharan
M.Pharm (Quality Assurance)
Assistant Professor
DSTSM’s College of Pharmacy, Solapur

2. Quality Audit
Definition: A systematic & independent
examination to determine whether quality
activities comply with instilled system
Audit
Internal
External

3. Quality Auditing
Periodic review & evaluation of all procedures and
operations both in manufacturing and QC to see-
• They are appropriate
• They are being followed as written
• Appropriate records are maintained
Definition: Periodic systemic examination & evaluation
of all activities related to quality of product or
services to determine the auditability &
effectiveness of the activities to meet quality goals.

4. Importance of Quality Audit
1. To obtain unbiased management information
2. To know factually if company is at risk
3. To assess individuals performance
4. To check follow-up of GMP
5. To identify deficiencies and faults
6. To investigate root cause of problem
7. To control external activities
8. To educate and train people
9. To make supplies aware of your problem

5. Internal audit
1. Quality System Audit
2. Management quality
audit
3. Process quality audit
4. Data processing unit
5. Product quality audit
6. Decision sampling
External Audit
1. Quality system
certification
2. Vendor audit
3. Regulatory Control
4. Quality system
improvement audit
5. Product
certification

6. Quality Audit Unit
1. Team Audit 2. single Auditors
Auditor’s Qualities:
 Realistic , practical & capable
 Communication skills
 Keen observer
 Well versed with documentation
 Fully aware of GMP

7. Auditor’s Training
Part A: Initial Program
• Basic working philosophy
• A review of product , regulations & QA
• Demo of Audit process
Part B: continuous Training
• Review & discussion of all QA Unit finding
• Technical
• Non-technical
• Learning from other auditors
• Review & discussion of appropriate journal articles
• Attendance of professional meetings

8. Audit Levels
1.
• Self Evaluation
• 1-Informal-Daily2.Formal-Quarterly
2.
• Internal
• Quarterly/Semi-annualy
3.
• Independent External
• Annually

9. Frequency of Audits:
Total Quality Audit: Once in year
Area Audits/Line Audits: more than once in year
Planning Quality Audits : Audit Team
 Decide the elements
 Determine dates & inform others
 Plan unannounced conduction of audit
 Should have enough information like
- Organizational structure, staff size and details, floor
plan, work load, violative samples & court cases per
year, problem areas, previous audit reports,
instruments & maintenance.

10. Audit Visit
 Purpose of visit
 Agenda for evaluation
 Criteria & Audit guidelines
 Any area/concerns feels needy for attention
Staff meeting For:
• Purpose of visit
• Mode of evaluation
• Duration of audit

11. Checklist for QA Unit
• Organizaion & responsibility
• Specifications
• SOPs
• Label devlopment/Approval/Reconcillation.
• Insect & rodent control
• Employee training
• Deviation Procedure.
• Laboratory equipment calibration.
• Stability studies.
• Consumer Complaints.
• Qualification suppliers contract mtgrs.
• Product tracebility.
• Process water treatment.

12. Checklist for QA Unit
• Mfg. equipment calibration/Maintenance.
• Equipment cleaning.
• Reprocess Control.
• Employees facility (toilet,uniform etc.)
• Segregated areas.
• Storage of materials.
• FIFO principle.
• Return Goods.
• In process control.
• Yield reconciliation.
• Process Validation.
• Cross contamination.
• Documentation (schedule ‘U’ of D&C Act)

13. Checklist for QA Unit
• Weighing & dispensing.
• Sanitation Procedure.
• Analytical test procedure.
• Reagents,std solution& reference std.
• Sampling plans.
• Micro control & background checks.
• Disrtibution/stock rotation.
• Recalls/withdrawals.
• Enviornmental Controls (Temp; humidity etc.)

14. Difficulties in Audits
1. Critical:
- Cross contamination
- Incorrect Labelling
- Active ingredients outside specifications
- Open sterile products in non-specific area
2. Major:
- Lack of SOPs for cleaning equipment
- Audit of a contract manufacturing not conducted
- Lack of calibration
- Inadequate segregation
3. Minor:
- Crack in wall surfaces
- Non-completion of batch record entries
- Inadequate cleaning of warehouse

15. Auditing Procedure
1. Preparation
2. First modification
3. Examination
4. Second modification
5. Evaluation
6. Referral
7. Conformance report
8. Final modification

16. Approaches to Quality Audit
1. Product Line Approach
2. System Approach
3. Performance Audit:
1. Onsite analyst work review
2. Independent sample examination
3. Intra & inter laboratory checks examination
Performance
Audit
Worksheet review
Oral Worksheet review

17. Audit Reports
Auditor must check the following:
Existence of raw data
Accuracy of graphical representations
with and Vs raw data
Presence of report elements
Conformance of the study to protocol
Computer generated data verification

18. Essential features of Audit Reports
 Timely prepared: one week-one month
 Covering every detail of quality audit
 Should reflect:
1. Overview of important results
2. Deficiencies noted
3. Reasons of changes
4. Corrective Action
 Non-threatening and constructive language
Audit Compliance Status report
 Corrective actions taken in time
 Steps taken to prevent recurrence