“A systematic and independent examination to
determine whether quality related activities and their results comply with documented systems, are effectively implemented and are suitable for achieving the quality objectives. ”

 “ Every audit is unique due to the auditor and auditee and its varies by personal judgment, past experiences, auditing style , basis perceptions, opinions , culture value systems, personalities and management style. ”

They must remain free from bias and conflicts of interest Evidence: Audit evidence must be verifiable and on sample basis.Principles of Audit : Independence: Auditor must be independent of the activity being audited. .

.  Third Party :An audit by a body which is commercially and contractually independent of the organization. its suppliers and customers. (Internal Audit / Self inspection)  Second Party /External :An audit conducted by its supplier/customer.Types of Audits :  First Party : An audit by the organization of its own systems and procedures.

Agreed corrective actions should be completed in a timely and effective manner.FDA’s REQUIREMENT  In order to verify compliance with the principles of GMP.  Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. regular internal audits should be performed in accordance with an approved schedule. .

To update and ensure implementation of SOPs/Policies across the organization as per approved quality system. analyze and evaluate the present technical documents in the light with regulatory guidelines and current industry practices and approved procedure. . It is a check to ensure that the quality management systems are operating effectively in accordance with the established standards.Internal Audit means . To Review.

0 Audit Planning 4.0 Staffing and Training 3.0 Evidence 8.0 Independence 2.0 Due Care 6.Keys for effective internal Audits : 1.0 Evaluation of the internal control system 7.0 Relationships 5.0 Reporting and follow-Up .

The internal auditor should be properly trained to fulfil all his responsibilities . having regard to its responsibilities and objectives.Keys for effective internal Audits : 1. qualifications and experience.0 Staffing and Training : The internal audit teams should be appropriately staffed in terms of numbers.0 Independence : The internal auditors should be a independence in term of organisational status . 2. department and personal objectives.

 Be punctual and to the point. check-lists etc.Keys for effective internal Audits : 3.  Follow the required entry/exit procedure Audit objective.0 Audit Planning :  Be ready with audit agenda. Audit Scope and Audit team should defined .

 May prevent the auditor from investigating significant incidents simply because they were not on checklist .Keys for effective internal Audits : Audit Checklist :checklist. time. Disadvantages:  May restrict for analysis of problem in depth.  To control the depth of the audit  To control the pace of the audit  It helps to ensure that audit area is covered completely – Nothing is missed.tif Advantages:  Guide to auditors for samples.

the internal auditor should be able to show that his work has been performed in a way which is consistent with regulatory requirements.Keys for effective internal Audits : 4.0 Due Care : To demonstrate the due care . 5. when auditors has confidence in auditee. 6. The internal auditor should possess a thorough knowledge of the aims of the organisation and the internal control system.0 Evaluation of the internal control system : To ensure compliance with statutory requirements. .0 Relationships: Internal audit can be performed properly .

8.0 Reporting and follow up :The internal auditor should ensure that findings. . conclusions and recommendations arising from each internal audit assignment are communicated promptly to the appropriate level of management and it is implemented .0 Evidence : The collection and assessment of internal audit should be recorded and reviewed to provide reasonable assurance that conclusions are soundly based and internal audit objectives achieved.Keys for effective internal Audits 7.

Experience .Qualities of an Effective Auditor An auditor need to be…. focused) Honest Professional Approach .  Educated . Open minded.and         Competent Diplomatic (Tactful in dealing with people) Observant (Aware of physical surroundings) Perceptive (Understand the situations) Decisive (Timely conclusion based on logic) Self-reliant (Interact but function independently) Firm (Persistent.

Do’s and Don'ts Be Punctual Do not interrupt to auditee Don’t shout Stop and Listen carefully Don’t run Don’t argue .

calm and professional at all             time. Collect evidence (for and against) Document non-compliances.Responsibilities of auditors  Auditor should remain polite. Verify the corrective actions/compliances Give compliments/Appreciate for good things Don’t assume on opinions versus fact that what you saw . Communicate the audit requirements. Introduce with the purpose/scope Keep to agenda Keep control (never talk down) Listen to others Speak clearly and carefully Stay within the audit scope.

Planned during wrong period Extended beyond defined scope Aggressive auditees Less talking auditees Missing people Missing documents Special cases Emotional blackmail .Auditor Should be Prepared  Unsystematic and unfocussed approach  Negative feelings and opinions about audits in        the minds of auditee.

Storage of Materials Receipt Procedures Man and Material flow Testing Production .?                   Personnel: Health and hygiene. Packing and process controls Systems and procedures Qualifications and Validations Facility Deviation Change control Risk assessment Rejects and refusals Complaints Investigations Calibrations Environmental conditions Training But not limited. .What Auditor should look for ….

Techniques of Audits: 1. Collect and verify the information 2. Tracking . process and Product review ) 5. Record review ( Document . Observations 3. Interview 4.

Case Study .

           Picnic Rainy season Car Village Prince Black Horse Jungle Palace Coffee Temple Journey .

log books and drawing. Collect and Verify documents .0 Observation :  Observed the activity. procedure . 2. . Don’t obstruct and don’t stare.Techniques of Audits: 1.records . specification .0 Collect and verify the information.

How .  Question techniques : When.  Ask-Closed ended question . Concentrating .0 Interview :  Ask-open-ended question .Techniques of Audits: 3.Understanding.Who . where .  Leading questions should be avoided. Attending .  Every attempt should be made to give ease to the person .  Do not conclude by yourself on assumption  KEEP EYES AND EARS OPEN (Learning . .Remembering and Continually grasping and processing information )  Results from the interview should be summarized and any findings should be verified. show me  Interview the person while performing the activity at workplace.

Techniques of Audits: 4. notify the audit leader . procedure and standards . review records and procedures. assess the impact on the product and recommend to management to stop the production or process. Eg : .0 Tracking  If a problem is found.0 Record review ( Document .  Give auditee a chance to explain and defer situations to the audit team leader. process and Product review )  Ask questions. 5. check requirements .

Complaints Packing Batch records Dispatch Manufacturing  Dispensing RAW /Packing material  RECEIPT Approved Vendor Deviation Investigation OOS/ OOT Testing CAPA .

Stress confidentiality. Review on-line compliances if any.Audit report         State decision and conclusion Summarize positive and good points Explain major . Explain the findings and evidences carefully and precisely. minor and critical non-compliances. Give recommendations for improvements THANK THE AUDITEES .

 Self-inspection team members should be independent from those having direct responsibility for the areas being inspect. .  Team consists of qualified. including one from Quality Assurance. experienced senior personnel who can evaluate the situation objectively. There should not be any conflict of interest before carrying out the self-inspection.Self inspection Composition of self inspection :  There should be minimum two inspectors .

Self inspection report $$ . 15 days of  A Self inspection number is issued by Quality Assurance department on individual self inspection report as follows SIRI$$/@@ Where.  Self inspection log is maintained as per CQA-54/A1 . The self inspection should be completed within the scheduled date. SIR .  The self-inspection schedule is made by Quality Assurance CQA- 54/A2.last two digits of the Current Year Serial number starting from 01  Annexure CQA-54/A4 should be filled separately for each non compliance recorded as per specimen Annexure CQA-54/A3. . Procedure for Self inspection :  All the areas should be covered under self-inspection at least twice a year or whenever required.

which have direct impact on the quality of the product. “Major” and “Minor” .  Minor : Non-conformances which may not have impact on quality of the product.  Major : Non-conformances which may have indirect impact on quality of the product.  All observations noticed during the self inspection should be submitted within 48 hrs in Annexure CQA-54/A3 .  Critical : Non-conformances.Report Finding : Non compliances are classified into “Critical”. .

 Close out of self-inspection report : Within 30 days.  Trending of the self inspection findings :Six monthly .  Non. Inspector should discussed the non conformances points with Head of department . Quality Assurance and Unit Head .  Investigation of each non-conformance points should be justified in annexure CQA-54/A4 by an auditee.conformance submitted criteria :  Critical non-conformance : Within 24 hours  Major and Minor non-conformance :Within 15 days.

an individual shall participate in three self inspections along with experienced and certified self inspector.  Phase l : Observer  Phase ll : Assist the experience self inspector  Phase lll : The individual under evaluation shall work as self inspector and the activities shall be monitored by the experienced Self Inspector.Certification of self inspector  For evaluation as a Self Inspector. .

tif .  Evaluation shall be done for each section in the department separately. Evaluation is carried out out during each phase by certified self inspector as per Annexure QA-10 A26.  Based on evaluation Quality Assurance shall issue certificate for designated section as per Annexure QA-101A25. .

inspection and inspection approach.  In current changing scenario of regulatory requirements. improvement .root cause analysis and provides tools to capture effectiveness. there is need to strengthen Policies by internal audit to Upgrade and Harmonize Quality Policy and ensure effective implementation. .Internal audit  Internal audit program help in solving problem .

 WHO TRS -908.  Pharmaceutical Inspection Co-Operation Scheme 1 .Reference     EU GMP Guidelines Indian GMPs : Schedule M Canada Guideline Internal Audit Committee of the Malaysian Institute of Accountants from the publication "Guidance for Internal Auditors" issued in June 1990 under the aegis of the Consultative Committee of Accountancy Bodies (CCAB) in the United Kingdom. September 2003  SOP CQA-54 and QA-10 .

Case Study .


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