As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
CHAPTER-1 Information Gathering and Administration.pdfDr. Dinesh Mehta
During the audit, information relevant to the objectives, scope and criteria, including information on interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified.
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
CHAPTER-1 Information Gathering and Administration.pdfDr. Dinesh Mehta
During the audit, information relevant to the objectives, scope and criteria, including information on interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
Auditing of critical parameter:- HVAC(heating, ventilation and air conditioning system) 2021; In these presentation includes the requirement of HVAC, Auditing of HVAC components, technical analysis of HVAC components, WHO-GMP audis of HVAC then
Rogert william statement on HVAC, working of HVAC systems and their components Core function of HVAC, Market trends and market analysis of HVAC, WHO guidelines on HVAC system.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
Auditing of critical parameter:- HVAC(heating, ventilation and air conditioning system) 2021; In these presentation includes the requirement of HVAC, Auditing of HVAC components, technical analysis of HVAC components, WHO-GMP audis of HVAC then
Rogert william statement on HVAC, working of HVAC systems and their components Core function of HVAC, Market trends and market analysis of HVAC, WHO guidelines on HVAC system.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
Introduction types, Objectives, Management of audit, Responsibilities, Planni...Kunal10679
Audit and regulatory Compliance M.pharmacy Quality Assurance department Sem. 2 Introduction types, Objectives, Management of audit, Responsibilities, Planning Process, Information Gathering, Classifications of Deficiencies of auditing
quality audit is essential for every organization . It discover the draw backs and then by improving this we can grow .It provide high degree of confidence.
This ppt consists of types of FDA inspection, and how to prepare for FDA inspection of pharmaceutical mfg site, and what to do before FDA inspection, During FDA inspection, and after FDA inspection.
CHAPTER-1 Management Audit and Planning procedure.pdfDr. Dinesh Mehta
Audits are conducted to ascertain the validity and reliability of the information; also to provide an assessment of the internal control of a system. It provides management with information on the efficiency with which the company controls the quality of its processes and products
Define, select, and apply various techniques including supplier qualification, certification, evaluation, ratings, performance
improvement, and so on.
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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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2. IMPORTANCE OF AUDITS IN PHARMA INDUSTRY
PRESENTED BY:
SWATHI.P
1ST M.PHARM
DEPT. OF PHARM QUALITY ASSURANCE
GUIDED BY:
Mr. J.S.K.NAGARAJAN
DEPT. OF PHARM. ANALYSIS
JSS COLLEGE OF PHARMACY , OOTY
2
3. 3
CONTENTS
WHAT IS AN AUDIT
OBJECTIVES OF AUDIT
PURPOSE OF AUDIT
TYPES OF AUDIT
COMPONENTS OF AUDIT
IMPORTANCE OF AUDITS
AUDIT TRAINING
SOP FOR AUDITING
AUDITING PRINCIPLES
COMPLIANCE CLASSIFICATION
REFERENCES
AUDITING PROCEDURE
CONCLUSION
4. WHAT IS AN AUDIT?
Auditing are conducted to ascertain the validity & reliability of the info.
To provide an assessment of the internal control of a system.
Audit defined - inspection of a process/system to ensure that it meets the requirements.
“Systematic, independent & documented process for obtaining audit evidence & evaluating
them objectively to determine the degree to which the verification criteria are met”.
Provides management with information on the efficiency.
In FDA & ISO, auditing of both compliance and performance is essential.
Pharmaceutical Audit experience includes
1.Drafting & revision of validation policies
2.Guidelines and SOP’s , from project qualification to performance evaluation phases.
4
5. OBJECTIVES OF AUDIT
Evaluating conformity of requirements to ISO 9001.
Evaluating conformity of documentation to ISO 9001.
Judging conformity of implementation to documentation.
Providing an opportunity to improve the quality management system.
Providing Registration and inclusion in a list of registered companies.
To determine the conformity & non-conformity of the quality system in meeting the
specified requirements
To determine the effectiveness of the implemented quality in meeting the specified
Quality objectives.
5
6. WHY AUDIT?
1. To initially evaluate the supplier where there is a desire to establish a contractual
relationship.
2. To verify that an organization own quality system continues to meet specified
requirements and is being implemented.
3. To evaluate an organization’s own quality system against quality system standard.
4. Within a framework a contractual relationship to verify that the suppliers quality
system continues to meet specified requirements and is being implemented.
6
7. TYPES OF AUDITS
7
•First party Audit or self-audit
•Auditor & those being Audited belongs to same organization.
• Eg.QA Department
•Second party Audit
•Customer conducting an Audit on a supplier or contractor.
•Ex. QSR, ISO 9001 or ISO 13485 standards
•Third-party Audit
•A Regulatory agency or an independent body performs this
Audit.
•For Compliance or Certification or Registration
•Eg. FDA Investigator
8. To assist the internal control
system.
Builds confidence in Quality system
Safeguarding the assets
Detection and prevention of errors
and faults.
Verify the accuracy and authenticity
of errors and frauds
Improves performance
Effective assessment of GMP
compliance
Helps in smooth functioning
of the internal check system
Reduce the Risk of failure
Allow the reduction of some
activities (e. g. in-house
quality control (QC) testing of
starting materials
Ensures that requirements
are understood and met
BENEFITS OF INTERNAL AUDIT BENEFITS OF EXTERNAL AUDIT
8
9. General
Name of the company
Names & designations of persons constituting self inspection team
Organization chart of the company
Date of commencement of self inspection
Date of completion of self inspection
Personnel
Premises
Storage of starting materials
Weighing area
Equipments
Sanitation & hygiene
Production & in process control
Printed labeling & packaging material control
Quality control
Storage of finished products
Documentation
Calibration of instrument & measurement systems
Validation & revalidation
Complaints
Product recalls
Returned & salvaged drug products
Results of previous self inspection & corrective measures taken
Results of the current self inspection
Recommendations
Signature of persons comprising self inspection team
Items for self inspection [Internal audit]
9
10. 1. Risk Assessment - relevant risk factors
2. Scope Statement - activities during the audit project justification, the project
description, the deliverables, & the success criteria.
COMPONENTS OF AUDIT
3. Audit Program - audit procedures & objectives.
4. Audit Procedures - tasks that the auditor follows to gather, analyze, and document
during the audit.
5. Work papers - detailed documentation
10
11. Regulatory agencies play a very important role assuring the good quality so that
safe & effective product should be delivered to the public.
Auditing has become one of the important key for the success of a pharma company.
Quality is determined the firm complies with GMP requirements & makes
scientifically justified decisions.
1. Medicinal products high quality as people lives depend on it, although end product
testing of samples from each batch is important, it is not enough to ensure quality which
must be built in to the manufacturing processes.
2. To ensure the quality, establish & implement as effective pharmaceutical QA
system.
Quality can only be achieved when everyone works together to meet the challenge.
IMPORTANCE OF AUDITS IN PHARMACEUTICAL INDUSTRY
11
12. 5. Audits are intended to verify that manufacturing control systems are operating under the
state of control.
6. Audit can detect potential problems to permit timely correction
7. Audits can be used to establish with a high range of confidence to remain adequate level
of control by management.
CONTI
4. Pharmaceutical manufacturers commonly use audits as effective mechanism to verify
compliance with GMPs.
3. To assess the effectiveness of these QA systems & to ensure it follow GMP, self inspection
and other regulatory audits must be performed.
12
13. AUDITOR TRAINING
For becoming an Auditor one must undergo proper training.
Both internal auditors and supplier auditors have in-depth, interactive training in
audit techniques understand how audit activities complement quality risk
management processes ensure business compliance & identify quality improvements.
Auditor should have knowledge about
• Planning & preparation
• Structuring the audit
• Managing the audit team
• Classifying observations
• Close out & reporting
• CAPAs and
• Follow-up
Auditor should have specific knowledge related to all steps of quality audit.
They must be familiar with department in which he or she wants to carry out audit
13
14. AUDIT TRAINING PROGRAM
Auditing Basics
Auditing Types & Models
Audit methods, Tools & Techniques
The Audit process
Developing an Audit Plan & Aide Memoire
Internal Auditing & Improving the Audit System
How to Audit CAPA, OOS, OOT & QRM
Auditing Products Manufacturers
Classification of Observations
Auditing for Approval of Suppliers/Contractors
Auditing API Suppliers
Data integrity
14
15. Candidate who completed degree & have eight years on-the-job experience one or more of
the areas in the field.
WHO CAN BECOME AN AUDITOR
The certified Quality Auditor is a professional who understands the standards and principles
of auditing & the auditing techniques of examining, questioning, evaluating & reporting to
determine a quality system’s adequacy & deficiencies
A minimum of three years of experience in a decision-making position.
Knowledge and ability to effectively conduct different types of quality audits.
Able to effectively plan, communicate, & execute an audit within its defined scope,
including scheduling resources, conducting meetings & using appropriate techniques to
identify, gather, and classify objective evidence
Able to verify, document, & communicate audit results, develop an audit report, and
evaluate the adequacy of the corrective and preventive action plan and follow-up
Able to select appropriate quality tools & auditing techniques for effective use in a variety
of practical applications
15
16. 1.NAI – (No Action Indication): No objectionable conditions or practices (e.g., violations of 21
CFR Parts 50, 54, 56, 312,511, and 812) were found during the inspection, or the significance of
the documented objectionable conditions found does not justify further FDA action. No
objectionable conditions or practices were found by the FDA.
COMPLIANCE CLASSIFICATIONS
2. VAI – (Voluntary Actions Indicated) :Objectionable conditions were found & documented,
but the Center is not prepared to take or recommend any further regulatory (advisory,
administrative, or judicial) action because the objectionable conditions do not meet the threshold
for regulatory action (i.e., regulatory violations uncovered during the inspection are few and do
not seriously impact subject safety or data integrity). A VAI classification should be made only if a
FDA-483 has been issued.
3. OAI – (Official FDA Action Indicated):If objectionable conditions were found, one of the
actions listed below should be recommended. Specifically, regulatory violation(s) uncovered during
the inspection is repeated or deliberate & involve submission of false information to FDA or to the
sponsor in any required report. The regulatory violation uncovered serious support a finding that:
a) Subjects under the care of the investigator would be or have been exposed to an unreasonable
and significant risk of illness or injury.
b) Subjects' rights would be or have been seriously compromised.
c) Data integrity or reliability is or has been compromised.
16
17. 7. Corrective action to be taken as a result of deficiencies uncovered during
the auditing including time-tables & provision for re-audits when appropriate.
6. Written reports on audits including their distribution
5. Frequency of auditing
4. Chosen areas subjected to auditing
3. Statement of purpose scope of audits
2. Composition of the auditing team with clarity on their authority &
responsibility
1. Information regarding the company policy pertaining to auditing.
STANDARD OPERATING PROCEDURES FOR AUDITING
17
21. Overview of audit activities
Initiating the audit
Appointing the audit team leader
Defining the audit objectives ,scope, criteria
Determining the feasibility of the audit
Selecting audit team
Establishing initial contact with the auditee
Conducting document review
Reviewing relevant management system documents, including records
records & determining their adequacy with respect to audit criteria
Preparing for the onsite audit activities
Preparing the audit plan 21
22. Assigning work to the audit team
Conducting on site audit activities
Conducting opening meeting
Communication during the audit
Roles and responsibilities of guides and observers
Collecting and verifying information
Generating audit findings
Preparing audit conclusions
Preparing, approving and distributing the audit report
Preparing the audit report
Approving and distributing the audit report
Completing the audit
Conducting the audit follow up 22
24. 24
CONCLUSION
A Quality system approaches calls for audits to be conducted at
planned intervals to evaluate effective implementation &
maintenance of the Quality system.
Integral part of an industry & cannot be neglected as it helps in
product realization, process perfection, quality monitoring.
Serves as Regulatory compliance and business needs.
Tool for continuous improvement of quality system of an industry.