SELF INSPECTION

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
 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
 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
 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.)

 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

 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
 Limitations of Personnel in audit

 Experience and knowledge, which is individual.

 Emphasize on familiar issues as well as particular area

Self Inspection Program Flow chart
 Audit Format and Approaches

 Manual GMP audit methods can be divided into categories;

Checklist format

GMP regulation approach

 Systems analysis method

 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
 Checklist Format
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.
 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.

 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
 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.
 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

 Final report

 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.
 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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