genrally for the M.phar students.

1. Audit And
Regulatory
Compliance.
Presented by-
Bhalekar Soham Rajendra
F.Y.M.Pharm (2nd Semester)
(PQA Department).
Roll No-03.
Guided By-
Prof. N.S.Mhaske
Dr. Vitthalrao Vikhe Patil Collage Of Pharmacy Vilad Ghat
Ahmednagar
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2. Content:
 Introduction.
 cGMP Regulations.
 Auditing of Packaging.
 Audit checklist for Drug Industry.
 Audit in Microbiological Laboratory.
 Auditing of Quality Assurance and Engineering Department.
 Auditing Report.
 Reference.
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3. Introduction :
• Definition:
Auditing is the on-site verification activity, such as inspection or
examination of a process or quality system, to ensure compliance to
requirements.
OR
Auditing is an systemic examination of Book, Accounts, documents and
voucher of an organization to ascertain how far financial statement present
true or fair view of an concern.
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4. Objective:
To determine CONFORMITY or NON CONFORMITY of
the Quality System.
 To determine the EFFECTIVENESS OF IMPLEMENTED SYSTEM in
meeting specified quality objectives.
 To afford an APPORTUNITY TO IMPROVE Quality system.
 To provide Manages with INFORMATIONS.
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5. Types of An Audit:
• Main 2 Types of Audit
1. External Audit
2. Internal Audit.
3. Regulatory Audit.
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6. • Pharmaceutical manufacturers commonly use audits as an effective
mechanism to verify compliance with GMP
regulation (GMP).
 GMP audits with two important goals:
1. Audis are intended to verify that manufacturing and Control
systems are operating under a state of control.
2. Audits permit timely correction of potential problems.
3. Audits can be used to establish a high degree of confidence to
remain under an adequate level of control by managements
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7. Management of Audits :
Responsibilities--
• Management is responsible for preparing the financial statements and the
contents of the statements are the assertions of management.
• The independent auditor is responsible for examining management's
financial statements and expressing an opinion on their fairness.
It Involves:
1. First Party Audit.
2. Second Party Audit.
3. Third Party Audit.
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8. Responsibilities of an Auditor:
1. Provide An Audit Report
• A qualified opinion – this states that the financial statements give a true
and fair view of the company's state of affairs except for certain stated
circumstances.
• A disclaimer of opinion– this states that the auditor is unable to form an
opinion as they were unable to gather a sufficient amount of competent
evidence.
• An adverse opinion – this states that the financial statements do not give a
true and fair view.
2. Report Failure To Maintain Proper Books Of Account.
3. Duty To Report Indictable Offences.
4. Duty To Exercise Professional Integrity.
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9. 9

10. cGMP Regulations:
The basic elements are derived from the following subpart of
regulations.
• Subpart B: Organization and personnel.
• Subpart C: Building and facilities.
• Subpart D: Equipment’s.
• Subpart E: Production and Processing Controls.
• Subpart F: Production and Packaging control.
• Subpart H: Holding and Distribution.
• Subpart I: Lab controls.
• Subpart J: Records and Reports.
• Subpart K: Returned and Salvaged drug.
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11. Checklist For Packaging:
Storage area and packaging
materials.
1.2.1 Are all chemicals (pestricides,sanitizers,detergents,lubricants
etc.)stored secularly safely and are they labeled correctly?
Storage area and packaging
materials.
1.2.2 Are food grade and non food grade chemicals used appropriately
according to labeled and stored in control manner?
Storage area and packaging
materials.
1.2.3 Is packaging stored to prevent cross contamination?
Storage area and packaging
materials.
1.2.4 Is the storage area completely enclosed?
Storage area and packaging
materials.
1.2.5 Is the facility used restricted to the storage of packaging material?
Storage area and packaging
materials.
1.2.6 Are rejected on hold materials clearly identified and separated
from other materials?
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12. Packaging: 12

13. Packaging Material and Vendor Audit :
Line clearance.
Contamination control.
Validation and Qualification.
Sampling.
Documentation.
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14. Audit Checklist for the Drug industry:
 Sanitation and Hygiene.
 Validation and Revalidation Program.
 Calibration of Instruments or measurement systems.
 Recall Procedures.
 Complaints management.
 Labels Control.
 Result of Previous Self-Inspection and corrective step taken.
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15. What is the Areas of Audit in Micro Lab...?
 Media preparation and quality control.
 Maintenance of microbiological cultures.
 Maintenance of laboratory equipment.
 Laboratory layout and operation.
 Training of personnel.
 Documentation.
 Maintenance of laboratory records.
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16. Auditing of Quality Assurance and Engineering
Department:
 Critical System :
1. Water
2. Water for Injection.
3. Effluent Treatment Plant(ETP).
4. HVAC.
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17. 1. Water :
 What is water Audit?
Water Audit is a qualitative and quantitative analysis
of water consumption to identify means of Reducing, Reusing
and Recycling of water.
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18. 1. Water :
Source
of
water
River
Municipal
supply
Dug
Well
Bore
well
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19. 2. Water For Injection System :
• Water for injection is water of extra high quality without significant
contamination. A sterile version is used for making solutions that will be
given by injection.
• If it is given by injection into a vein without making it more or less
isotonic, breakdown of red blood cells may occur.
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20. 2. Water For Injection System :
Audit Process For WFI :
I. Microbiological levels.
II. Pyrogen Test.
III. Pharmaceutical Grade Water.
IV. Storage Condition.
V. Specification For Water for Injection.
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21. 3. Effluent Treatment Plant(ETP) :
• ETP is essential to purify the waste water which is coming from different
types of manufacturing industry like textile, ternary, dyes, and chemical
manufacturing industry, pharmaceuticals etc.
• “ETP” is very important that all the sewage, waste water and chemicals
that used in the manufacturing processes are collection, storage, processes
and disposal are managed in effluent treatment plant.
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22. Process Flow Chart Of ETP :
Effluent from different manufacturing industry
Primary Filtration
Cooling and Mixing
Neutralization (by acid or alkali)
Chemical Coagulation
Setting and Separation of Sludge
Pressure
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23. 4. HVAC : 23

24. 4. HVAC :
Questions about equipment health and energy expenditures during Audit
including:
How much energy does the HVAC system consume?
 Where and when is energy use heaviest and lightest?
What areas and equipment cause the most energy loss?
What are the ages, types, and conditions of system components?
Does the system pose a health risk?
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25. 4. HVAC :
Checklist for HVAC Audit :
 Air filters.
 Boilers.
 Cooling coils and condensation drip pans.
 Cooling towers and chillers.
 Ducted returns.
 Exhaust fans.
 Heating and reheating coils.
 Outside air intake and air quality.
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26. Auditing Report :
• It Provides a record which Identifies and may be useful for prioritizing (
Critical, major, Other ) areas of improvement.
• Report should be drafted and final version issued as soon as possible after
completing the Audit.
 There are two important Reporting Phases of Audit :
1. Preliminary Report During the Audit.
2. Final Report to the Management.
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27. References :
K. T. Patel1, N. P. Chotai, Vendor qualification for pharmaceutical
excipients – GMP requirements and approach. Vallabh Vidhyanagar,
Gujarat, India .
James Agalloco and Frederick J. Carleton, Page No : 443 to 453 . Third
Edition, Validation of Pharmaceutical Processes .
Saghee MR, Sandle T, Tidswell EC, p. 237–58.editors. jMartin A. Auditing
a QC microbiology laboratory. In: Microbiology and sterility assurance in
pharmaceuticals and medical devices. New Delhi: Business Horizons;
2011.
James Agalloco and Frederick J. Carleton,Page no:73 Validation of
pharmaceutical processes, third edition.
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