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.
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
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
19. If you would like to donate us?
Scan below and donate us 0.013$ (US dollar) (5Rs Indian rupee)
Contact: If you want PPT/PDF files, please contact below.
Email: gnccmysore@gmail.com
Telegram:+919738137533(only for Chat)