Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.

1. SELF INSPECTION

2. Quality Audit
 Definition:
Quality audit is a process of examination and
verification of procedures, records, and activities
of a quality system that is carried out by an audit
team or an internal or external quality auditor.
Quality audit is considered an integral part of the
quality management system and is considered as a
critical component in GMP

3. What to check?
 Objective: To identify the potential discrepancies in,
Documentation
Sanitation and hygiene practices
Validation and revalidation programs
Calibration of instruments or measurement systems
Recall procedures
Complaints management
Labels control
Results of previous self-inspections verifications

4. Who can audit?
 Lead auditor is usually a senior auditor who has extensive
knowledge of the firm’s operations and exhibit strong
leadership qualities.
 SMEs from CFT departments
 Minimum graduation/Diploma and minimum five-year
experience in Pharmaceutical industry
 Sound knowledge of cGMP, Quality system, SOP’s, material
and product standard

5. Defining Auditor Qualification
 Selected based
On their knowledge
Experience in manufacturing and QC principles as well as years
of firsthand experience dealing with GMP matters.
Any other technical expertise
Auditor certification (ASQ), IRCA, ISO etc.)

6. Pre-requisites for Auditor
Willing to consider alternate ideas for observations
(Logical)
Auditor must know the process & analytical
techniques
Faith, Truthful, Sincere, honest.
Tactful dealing with people

7. Selecting Audit teams
 Team is required for cover many different systems and large
amount of data.
 Composition of team will vary depending upon the nature and
scope of the audit.
 Team Size
2 to 3 members
Team shall be formed by QA Head/Designee

8. Limitations of Personnel in audit
 Experience and knowledge, which is individual.
 Emphasize on familiar issues as well as particular area

9. Self Inspection Program Flow chart

10. Audit Format and Approaches
 Manual GMP audit methods can be divided into categories;
Checklist format
GMP regulation approach
 Systems analysis method

11. Checklist Format
• Use checklist as GMP audit guides and reporting
finding.
• Series of questions or instructions are grouped into
logical order.
• Blocks may be used to record answer and space may
be provided to make comments

12. Advantages:
 Simple, convenient and easy to use for any desired subjected area
 Knowledgeable personnel may develop questions and guideline
 Questions are in logical order that help auditor to detect problems
 Report can be prepared in a minimum amount of time
Disadvantages:-
 Question may be interpreted in more than one way because of bias or
hidden meaning.
 Solve the devising questions is not easy task.
 Limited content.
Checklist Format

13. Detecting Potential Problems
 GMP audits find objectionable condition that is unknown
to responsible production, QC, QA or management
personnel.
 The auditor will see whether such actions are frequent or
not. From this he can identify other GMP problems
 Guidelines / Regulations shall be referred.

14. Detecting Potential Problems
 Procedures / Practices must be inline with the requirements of
Regulatory Agencies (FDA, EU, CA, etc.)
Industry Guidance (ICH, ASNI, ISO, WHO, USP-NF, etc.)
Quality Manual
Site procedures (Quality System)
Key Elements for Data Integrity

15. Interrogations during the audit
1) Benefits can be gained from having questions with
employees.
2) Findings are communicated with affected personnel.
3) Discussion may help the employees to learn why
problems happened.

16. Reporting Audit Finding
 Audit reports should contain complete details of the
program,
observation detected with objective evidences/references.
Corrective Actions taken
Acceptance and review by Auditor
Shall provide overall adequacy of program

17.  Must review and determine what steps need to be taken to
eliminate deficiencies.
 Should sincerely encourage detection of problems and
express appreciation for being able to improve quality
operations
 May be shared with Head of each department who may
discuss finding with employees.
 The workers and supervisory personnel should be given
the opportunity to explain their views and ideas about the
audit findings.
Final report

18. Effective Programme / Improvements
 Changing SOPs
 Modifying manufacturing equipment or procedure
 Upgrading equipment or procedure
 Improving employee training programme
 Developing new or revised documentary system

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