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OBJECTIVES, MANAGEMENT OF AUDIT,
RESPONSIBILITIES, PLANNING
PROCESS, INFORMATION GATHERING,
CLASSIFICATIONS OF DEFICIENCIES
1
Kunal Anil Suryawanshi.
M.Pharm Quality Assurance
Sub: Audit and regulatory Compliance
2
Vision :
• To be the center of professional excellence by contributing honestly to the pharmacist
molding process.
Mission :
• Impart high-quality education to graduates.
• Contribute to all spheres of professional activities.
• Uphold human values and ethics.
• Nature them into globally competent professional
Introduction and Objectives of Audit
• An audit is a systematic and independent examination, review, or evaluation of a process,
system, organization, or set of financial records to ensure accuracy, and compliance with
established standards or regulations, and to identify areas for improvement.
• The International Organization for Standardization (ISO) defines the audit as a
"Systematic, independent and documented process for obtaining audit evidence and
evaluating them objectively to determine the degree to which the verification criteria are
met”.
3
• An audit is a systematic and independent examination to determine whether activities and
related results comply with planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve objectives.
• Activities and their results are examined for compliance with plans and objectives.
The objectives of conducting an ISO audit are:
 To check the suitability of standards, regulations, procedures, and conditions of implementation
in your organization.
 To ensure consistency in the implementation of processes.
 To look for areas of improvement and to develop key processes and working conditions in your
organization.
4
 To comply with statutory and regulatory requirements
 To fulfill customer requirements or market demands.
5
TYPES OF AUDIT
1. Internal Audit
2. External Audit
3. Regulatory Audit
6
1. Internal Audit:
Internal (1st Party) Audits
A key purpose of an internal audit is hopefully to identify minor problems and errors before they become major issues or are discovered
by a third party.
• Purpose:
 To ensure that adequate Quality systems are maintained.
 To assess compliance with the C-GMP and the firm’s standard operating procedure.
 To achieve consistency between manufacturing and testing facilities.
 To identify problems internally and Correct problems before an FDA inspection.
 Enhances organizational performance and efficiency, and assesses risk management, internal controls, and operational
processes.
• Scope: Can cover various aspects of the organization, including financial, operational, and compliance audits.
• Conducted by: Internal auditors employed by the organization.
• Examples: Financial audits, operational audits, compliance audits.
7
2. External Audit :
External Audit-External Audit (2nd Party)
A second-party audit is carried out by a non-regulatory auditor.
For example, in some industries, especially pharmaceuticals and chemicals, customers and potential customers will often ask to visit a
company; to ensure they are operating according to a quality system and hence will provide good quality goods.
• Purpose:
 Confidence in the partnership arrangement.
 Ensuring that requirements are understood.
 Enabling reduction of in-house QC testing of starting materials.
 Reducing the risk of failure.
 Carried out by a company on its vendors or subcontractors.
 No legal requirement to conduct an audit.
• Scope: Primarily focuses on financial statements to express an opinion on their accuracy and fairness. Conducted by: External auditors,
usually from accounting firms.
• Examples: Financial statement audits, and statutory audits required by law.
8
3. Regulatory Audit :
Regulatory Audit (Third party Audit)
A third-party audit is carried out by a Regulatory auditor or Inspector.
(These are a legal requirement in highly regulated industries such as pharmaceuticals and food production)
• Purpose: Ensures compliance with external laws and regulations.
• Scope: Focuses on adherence to specific legal requirements and industry standards.
• Conducted by: External auditors mandated by regulatory bodies.
• Examples: Tax audits, and compliance audits required by industry regulators.
9
10
Management audit is the examination review of various policies and actions of the management on the basis of
certain specified objective.
 Objectives of Management Audit (MA)
1. Evaluate operational efficiency in pharmaceutical processes.
2. Ensure compliance with regulatory requirements.
3. Optimize resource utilization for cost-effectiveness.
4. Assess quality control measures in pharmaceutical production.
5. Review adherence to industry standards and best practices.
11
RESPONSIBILITIES
The auditor has the following responsibilities:
Assist in the selection of the team and inform the team.
Responsible for planning and managing all phases of the audit.
Represent the audit team with the auditee.
Control conflicts and manage difficult situations.
Direct and control all meetings with the team and the auditee.
Make decisions about audit issues and the quality system.
Report the results of the audit without delay.
Report the main obstacles encountered.
Report critical non-conformances immediately.
Possesses effective communication skills.
12
Audit
Process
13
The audit planning and preparation steps include:
• Appointing and auditing co-ordinator
• Defining the scope of the audit
• Deciding frequency
• Preparing audit program
• Making audit schedule/plan
• Document review
• Preparation of audit checklists
14
7. formal report and
recommendations
8. Follow up the
Instruction given by
the auditor
2. Announce the
schedule of audit
6. Informal or oral
instruction
4. Conduct an meeting
3. Arrive or visit at the
site of audit
1. Plan and Arrange the
Audit
5. Perform actual
meeting
The
Planning
Process
15
.
Pre Audit Activities
• Select facility and schedule Audit
• Select team member and their availability
• Gather Background Information
• Prepare Audit Plan
.
Key Activities on site
• Step 1:- Opening Meeting
• Step 2:- Audit Evidence
• Step 3:- Audit Inspection
• Step 4:- Audit Conclusion
• Step 5:- Closing Meeting
.
Post Audit Activity
• Prepare Draft Report
• Draft Report Reviewed
• Issue Final Report
• Action Planning
• Follow up
Planning
Process
in
Different
Stage
16
Information Gathering:-
 In a pharmaceutical audit, information gathering is the process of collecting and evaluating data,
documents, and observations to assess a company's compliance with regulatory standards, including
Good Manufacturing Practices (GMP).
 During the audit, all necessary information should be collected by appropriate sampling and verified to
ensure it is relevant to the objectives, scope, and criteria.
 This includes information on interfaces between functions, activities, management operations, and
processes.
 Only verifiable information can be audit evidence which must be recorded
17
Audit
Evidenc
e
Audit
Findin
g
Source of Information
Collect sampling
And Verify
Evaluation against
Audit Criteria
Reviewing
Audit Conclusion
18
Methods of Gathering Audit Information
There are six basic methods of gathering information during an audit. Depending on the type of
information that needs to be obtained, the Internal Auditor will need to determine which method, or
combination of methods, should be used.
I. Interviewer
II. Inspection
III. Reviewing documents
IV. Performance
V. Analytical Procedures
VI. External Confirmation / Inquiry
19
Classification of Deficiencies
 Classification of deficiencies is as follows:-
Critical Deficiencies
• A deficiency is termed critical if it may cause a significant effect on the strength, identity purity,
and safety of the product and many have an adverse psychological response to the consumer.
• When a critical deficiency occurs there is a high probability of product recall.
• When critical deficiencies are observed in a manufacturing facility the inspector has to
recommend the pharmacy board.
• The withdrawal of manufacturing license or marketing authorization of a particular product
Level of
Deficiencies
Critical Major Minor
20
Critical deficiencies Occur due to
• Critical deficiency may be noted if one or all of the following is or observed.
• Cross-contamination
• There is no acceptable air supply system
• The material; flow is not logical
• There are no dedicated areas for weighting, storing, holding, processing, and packing of highly toxic
products (penicillin, cytotoxic materials, hormones, steroids)
• Key personnel not meeting qualifications
• Lack of proper controls in the handling of starting materials, in the processing of bulk materials, and
materials in quarantine of rejected areas.
• Wrong reconciliation of stating (raw) materials
• Improper documentation
21
Major Deficiencies Occur due to
• These are deficiencies that have no impact on the strength, identity, purity, or safety of the product. There is reduced
usability of the product without a probability of causing harm to the consumer.
• Observation of major deficiencies puts a question mark on the reliability of the firm’s quality assurance system.
• When a major deficiency is recorded, the inspector should recommend to the board that the manufacturer be required to
take corrective action within a given time frame.
• The pharmacy board may temporarily withdraw the manufacturing license and/or marketing authorization of the products
and ask the company to take immediate corrective action.
• Lack of self-inspection
• Poor training of the workers
• The equipment labeling system is not correct
• The documentation system is confusing
• Calibration is missing
• Storing of referenced standards and reagents is not correct
22
Minor Deficiencies
These are deficiencies with a low probability of affecting the quality or usability of the product. The inspector
has to pinpoint these deficiencies and ask for immediate corrective action by the manufacturer
Minor deficiencies Occur due to
• Small deficiencies in the documents (using correction pen, overwriting without signatures, some
missing in the batch record, etc.
• Signatures delay in the change of SOPs
• Unauthorized personnel entering the production area
• Label counting system not calibrated
• No evidence that thermometers were calibrated
• There was no requirement for persons with moustaches or beards to wear beard snoods in the
manufacturing area
23
References
I. Kaur J. Quality audit: Introduction, types, and procedure [Internet]. Pharma Pathway; 2017.
http://pharmapathway.com/quality-audit-introduction-types-and-procedure/.
II. Vedanabhlata S, Gupta VN. A review on audits and compliance management. Asian J Pharm Clin Res
2013;6:43- 5.
III. Sharma S, Kohli S, Potdar M. Current good manufacturing practices: Audit.
IV. Active Pharmaceutical Ingredients Committee (APIC). Auditing guide; 2016. Available from:
http://apic.cefic.org/pub/Auditing/APIC_CEFIC_Auditingguide August2016.pdf.
I. Review on "Pharmaceutical quality audits" by Princy Agarwal & Amul Mishra, November;2018.
II. Chartered Institute of Internal Auditors. How to gather and evaluate information;2017.
https://www.iia.org.uk/resources/delivering-internal-audit/how-/.
24
25

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Introduction types, Objectives, Management of audit, Responsibilities, Planning Process, Information Gathering, Classifications of Deficiencies of auditing

  • 1. OBJECTIVES, MANAGEMENT OF AUDIT, RESPONSIBILITIES, PLANNING PROCESS, INFORMATION GATHERING, CLASSIFICATIONS OF DEFICIENCIES 1 Kunal Anil Suryawanshi. M.Pharm Quality Assurance Sub: Audit and regulatory Compliance
  • 2. 2 Vision : • To be the center of professional excellence by contributing honestly to the pharmacist molding process. Mission : • Impart high-quality education to graduates. • Contribute to all spheres of professional activities. • Uphold human values and ethics. • Nature them into globally competent professional
  • 3. Introduction and Objectives of Audit • An audit is a systematic and independent examination, review, or evaluation of a process, system, organization, or set of financial records to ensure accuracy, and compliance with established standards or regulations, and to identify areas for improvement. • The International Organization for Standardization (ISO) defines the audit as a "Systematic, independent and documented process for obtaining audit evidence and evaluating them objectively to determine the degree to which the verification criteria are met”. 3
  • 4. • An audit is a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. • Activities and their results are examined for compliance with plans and objectives. The objectives of conducting an ISO audit are:  To check the suitability of standards, regulations, procedures, and conditions of implementation in your organization.  To ensure consistency in the implementation of processes.  To look for areas of improvement and to develop key processes and working conditions in your organization. 4
  • 5.  To comply with statutory and regulatory requirements  To fulfill customer requirements or market demands. 5
  • 6. TYPES OF AUDIT 1. Internal Audit 2. External Audit 3. Regulatory Audit 6
  • 7. 1. Internal Audit: Internal (1st Party) Audits A key purpose of an internal audit is hopefully to identify minor problems and errors before they become major issues or are discovered by a third party. • Purpose:  To ensure that adequate Quality systems are maintained.  To assess compliance with the C-GMP and the firm’s standard operating procedure.  To achieve consistency between manufacturing and testing facilities.  To identify problems internally and Correct problems before an FDA inspection.  Enhances organizational performance and efficiency, and assesses risk management, internal controls, and operational processes. • Scope: Can cover various aspects of the organization, including financial, operational, and compliance audits. • Conducted by: Internal auditors employed by the organization. • Examples: Financial audits, operational audits, compliance audits. 7
  • 8. 2. External Audit : External Audit-External Audit (2nd Party) A second-party audit is carried out by a non-regulatory auditor. For example, in some industries, especially pharmaceuticals and chemicals, customers and potential customers will often ask to visit a company; to ensure they are operating according to a quality system and hence will provide good quality goods. • Purpose:  Confidence in the partnership arrangement.  Ensuring that requirements are understood.  Enabling reduction of in-house QC testing of starting materials.  Reducing the risk of failure.  Carried out by a company on its vendors or subcontractors.  No legal requirement to conduct an audit. • Scope: Primarily focuses on financial statements to express an opinion on their accuracy and fairness. Conducted by: External auditors, usually from accounting firms. • Examples: Financial statement audits, and statutory audits required by law. 8
  • 9. 3. Regulatory Audit : Regulatory Audit (Third party Audit) A third-party audit is carried out by a Regulatory auditor or Inspector. (These are a legal requirement in highly regulated industries such as pharmaceuticals and food production) • Purpose: Ensures compliance with external laws and regulations. • Scope: Focuses on adherence to specific legal requirements and industry standards. • Conducted by: External auditors mandated by regulatory bodies. • Examples: Tax audits, and compliance audits required by industry regulators. 9
  • 10. 10
  • 11. Management audit is the examination review of various policies and actions of the management on the basis of certain specified objective.  Objectives of Management Audit (MA) 1. Evaluate operational efficiency in pharmaceutical processes. 2. Ensure compliance with regulatory requirements. 3. Optimize resource utilization for cost-effectiveness. 4. Assess quality control measures in pharmaceutical production. 5. Review adherence to industry standards and best practices. 11
  • 12. RESPONSIBILITIES The auditor has the following responsibilities: Assist in the selection of the team and inform the team. Responsible for planning and managing all phases of the audit. Represent the audit team with the auditee. Control conflicts and manage difficult situations. Direct and control all meetings with the team and the auditee. Make decisions about audit issues and the quality system. Report the results of the audit without delay. Report the main obstacles encountered. Report critical non-conformances immediately. Possesses effective communication skills. 12
  • 14. The audit planning and preparation steps include: • Appointing and auditing co-ordinator • Defining the scope of the audit • Deciding frequency • Preparing audit program • Making audit schedule/plan • Document review • Preparation of audit checklists 14
  • 15. 7. formal report and recommendations 8. Follow up the Instruction given by the auditor 2. Announce the schedule of audit 6. Informal or oral instruction 4. Conduct an meeting 3. Arrive or visit at the site of audit 1. Plan and Arrange the Audit 5. Perform actual meeting The Planning Process 15
  • 16. . Pre Audit Activities • Select facility and schedule Audit • Select team member and their availability • Gather Background Information • Prepare Audit Plan . Key Activities on site • Step 1:- Opening Meeting • Step 2:- Audit Evidence • Step 3:- Audit Inspection • Step 4:- Audit Conclusion • Step 5:- Closing Meeting . Post Audit Activity • Prepare Draft Report • Draft Report Reviewed • Issue Final Report • Action Planning • Follow up Planning Process in Different Stage 16
  • 17. Information Gathering:-  In a pharmaceutical audit, information gathering is the process of collecting and evaluating data, documents, and observations to assess a company's compliance with regulatory standards, including Good Manufacturing Practices (GMP).  During the audit, all necessary information should be collected by appropriate sampling and verified to ensure it is relevant to the objectives, scope, and criteria.  This includes information on interfaces between functions, activities, management operations, and processes.  Only verifiable information can be audit evidence which must be recorded 17
  • 18. Audit Evidenc e Audit Findin g Source of Information Collect sampling And Verify Evaluation against Audit Criteria Reviewing Audit Conclusion 18
  • 19. Methods of Gathering Audit Information There are six basic methods of gathering information during an audit. Depending on the type of information that needs to be obtained, the Internal Auditor will need to determine which method, or combination of methods, should be used. I. Interviewer II. Inspection III. Reviewing documents IV. Performance V. Analytical Procedures VI. External Confirmation / Inquiry 19
  • 20. Classification of Deficiencies  Classification of deficiencies is as follows:- Critical Deficiencies • A deficiency is termed critical if it may cause a significant effect on the strength, identity purity, and safety of the product and many have an adverse psychological response to the consumer. • When a critical deficiency occurs there is a high probability of product recall. • When critical deficiencies are observed in a manufacturing facility the inspector has to recommend the pharmacy board. • The withdrawal of manufacturing license or marketing authorization of a particular product Level of Deficiencies Critical Major Minor 20
  • 21. Critical deficiencies Occur due to • Critical deficiency may be noted if one or all of the following is or observed. • Cross-contamination • There is no acceptable air supply system • The material; flow is not logical • There are no dedicated areas for weighting, storing, holding, processing, and packing of highly toxic products (penicillin, cytotoxic materials, hormones, steroids) • Key personnel not meeting qualifications • Lack of proper controls in the handling of starting materials, in the processing of bulk materials, and materials in quarantine of rejected areas. • Wrong reconciliation of stating (raw) materials • Improper documentation 21
  • 22. Major Deficiencies Occur due to • These are deficiencies that have no impact on the strength, identity, purity, or safety of the product. There is reduced usability of the product without a probability of causing harm to the consumer. • Observation of major deficiencies puts a question mark on the reliability of the firm’s quality assurance system. • When a major deficiency is recorded, the inspector should recommend to the board that the manufacturer be required to take corrective action within a given time frame. • The pharmacy board may temporarily withdraw the manufacturing license and/or marketing authorization of the products and ask the company to take immediate corrective action. • Lack of self-inspection • Poor training of the workers • The equipment labeling system is not correct • The documentation system is confusing • Calibration is missing • Storing of referenced standards and reagents is not correct 22
  • 23. Minor Deficiencies These are deficiencies with a low probability of affecting the quality or usability of the product. The inspector has to pinpoint these deficiencies and ask for immediate corrective action by the manufacturer Minor deficiencies Occur due to • Small deficiencies in the documents (using correction pen, overwriting without signatures, some missing in the batch record, etc. • Signatures delay in the change of SOPs • Unauthorized personnel entering the production area • Label counting system not calibrated • No evidence that thermometers were calibrated • There was no requirement for persons with moustaches or beards to wear beard snoods in the manufacturing area 23
  • 24. References I. Kaur J. Quality audit: Introduction, types, and procedure [Internet]. Pharma Pathway; 2017. http://pharmapathway.com/quality-audit-introduction-types-and-procedure/. II. Vedanabhlata S, Gupta VN. A review on audits and compliance management. Asian J Pharm Clin Res 2013;6:43- 5. III. Sharma S, Kohli S, Potdar M. Current good manufacturing practices: Audit. IV. Active Pharmaceutical Ingredients Committee (APIC). Auditing guide; 2016. Available from: http://apic.cefic.org/pub/Auditing/APIC_CEFIC_Auditingguide August2016.pdf. I. Review on "Pharmaceutical quality audits" by Princy Agarwal & Amul Mishra, November;2018. II. Chartered Institute of Internal Auditors. How to gather and evaluate information;2017. https://www.iia.org.uk/resources/delivering-internal-audit/how-/. 24
  • 25. 25