Posted on April 30, 2008. Filed under: pharmaceutical quality | Tags: , , , |

By: Supriya Sharma, Shamita Kohli, Manohar Potdar

Poona College of Pharmacy, Bharati Vidyapeeth University, Pune.




The most general definition of an audit is “an evaluation of a person, organization, system, process, project or product”. Audits are performed to ascertain the validity and reliability of the information, and also it provides an assessment of a system’s internal control. The goal of an audit is to express an opinion on the person/organization/system etc. under the evaluation based on work done on a test basis. Due to practical constraints, an audit is a system which seeks to provide only reasonable assurance that the statements are free from material errors & other errors. Hence, random sampling is often adopted in the audits.

 A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the written protocol, sponsor’s standard operating procedures (SOPs), and the applicable regulatory requirement(s).

 All pharmaceuticals plants are required to turn out quality pharmaceutical products, which can be promote and disseminated in the commerce. The main intention of all the cGMP is to pull together this requirement of producing and distributing quality pharmaceutical products. To scrutinize the process of cGMP a system is required & this is only possible from beginning to end a well designed and implemented quality audit organization.

Principle behind Quality Audit system:

The philosophy of Quality Audit is based on the fashion of quality standards used in quite a lot of recognized countrywide and global standards such as the ISO-900x (where x is 0,1,2, etc.) worldwide quality standards. These standards do not in themselves generate quality. The common sense in the wake of is as follows.

All organization should characterize wide-ranging procedures by which their products or services can be delivered consistently to the desired level of the quality. The opinion is that each organization should create thorough, forbidden actions for each of its processes. Those procedures should deliver the quality that is sought. The Quality Audit, as a result, only needs to guarantee that the procedures have been distinct, forbidden, communicated and used. Processes will be put in place to deal with corrective actions when deviations occur. This attitude can be applied to uninterrupted business development operations or recurring project work. It would not be common to launch a set of quality forbidden actions for a one-off state of affairs since the accent is consistency.

The specific purpose of quality audits is to provide independent assurance that:

Plans for attaining quality are such that, if followed, the intended quality will be attained.

Products are fit for use & safe for the user.

Standards & regulations defined by government agencies, industry associations, & professional societies are being followed.

There are conformances to specifications.

Procedures are adequate & are being followed.

The data system provides accurate & adequate information on quality to all concerned.

Deficiencies are identified, & corrective action is taken.

Opportunities for improvement are identified, & the appropriate personnel are alerted.

Five basic principles of Quality Audit Program

1. An uncompromising emphasis on conclusions based on facts. Any conclusions lacking a factual base must be so labeled.

2. An attitude on the part of auditors that the audits provide assurance to management & also a useful service to line managers in managing their departments. Thus audit reports must provide sufficient detail on deficiencies to facilitate analysis & action by the line manager.

3. An attitude on the part of auditors to identify opportunities for improvement. Such opportunities include highlighting good ideas used in practice that are not part of formal procedures. Sometimes an audit can help to overcome deficiencies by communicating through the hierarchy the reason for deficiencies that have a source in another department.

4. Addressing the human relations issues discussed.

5. Competence of auditors. The basic education & experience of the auditors should be sufficient to enable them to learn in short order the technological aspects of the operations they are to audit. Lacking this background, they will be unable to earn the respect of operations personnels. In addition, they should receive special training in the human relations aspects of auditing. The American society for Quality provides a program for the certification of quality auditors.

Steps used in structuring an audit program


Audit department

Line department

Upper management

Discussion of purpose to be achieved by audits & general approach for conducting audits




Draft of policies, procedures & other rule to be followed.




Final approval




Scheduling of audits




Conduct of audits




Verification of factual findings




Publication of report with facts and recommendation




Discussion of repots




Decision on action to be taken




Subsequent follow-up




Planning audits for activities:

Important policies issues for planning audits:


The basic right to conduct audits is derived that has been approved by upper management, following participation by all concerned. Beyond this basic right are other questions of legitimacy: What is the scope & objective? What shall be the subject matter for audit? Should the auditor be accompanied during the tour?

Scheduled versus unannounced:

Most auditing is done on a scheduled basis. “No surprise, no secrets.” This practice enables all concerned to organize workloads, assign personnel, etc., in an orderly manner. It also minimizes the irritations that are inevitable when audits are unannounced.


The customer of the audit is anyone who is affected by the audit. The key customer is the person responsible for the activity being audited. Each customer has needs that should be recognized during the planning of the audit.

Audit team:

Audits are conducted by individuals or by a team. A team usually has a lead auditor who plans the audit, conducts the meeting, reviews the findings and comments of the auditors, prepares the audit report, evaluates corrective action, & presents the audit report.

Audit performance:

Several policy issues affect audit performance.

Verification of facts

Auditors are universally expected to review with the line supervision the facts of any deficiencies discovered during the audit. The facts should be agreed on before the items enters a report that will go to higher management.

Discovery of causes:

Many companies expect the auditor to investigate major deficiencies to determine their causes. This investigation then becomes the basis of the auditors recommendation.

Recommendations & remedies:

Auditors are invariably expected to make recommendations to reduce deficiencies & improve performance. In contrast, auditors are commonly told to avoid becoming involved in designing remedies & making them effective.

Status of the audit:

The key customer should be kept informed about progress of the audit- what has been covered & what remains to be done. The status of lengthy audits can be reported through debriefing meeting, informal discussions, & electronic mail.

The report should include minimum following items:


  • Executive summary
  • Purpose & scope of the audit
  • Details of the audit plan, including audit personnel, dates, the activity that was audited. Details should be placed in an appendix.
  • Standards, checklist, or other reference documents that were used during the audit.
  • Audit observations, including supporting evidence, conclusions, & recommendations-using the audit customer’s terminology.
  • Recommendations for improvement opportunities.
  • Recommendation for following-up on the corrective action that is to be proposed & implemented by line management, along with subsequent audits if necessary.
  • Distribution list for the audit report.


The quality audit system mainly classified in three different categories:

  1. Internal Audits
  2. External Audits
  3. Regulatory Audits

Quality audits are performed to verify the effectiveness of a quality management system.


1. Internal audit:

Internal auditing is a professional activity involved in advising organizations regarding how to achieve their objectives in a better way. Internal auditing involves the utilization of a systematic methodology for analyzing business processes or organizational problems and recommending solutions. Professionals called internal auditors are employed by organizations to perform the internal auditing activity. The scope of internal auditing within an organization is broad and may involve internal control topics such as the efficacy of operations, the reliability of financial reporting, deterring and investigating fraud, safeguarding assets, and compliance with laws and regulations. Internal auditing frequently involves measuring compliance with the entity’s policies and procedures. Internal auditing activity is primarily directed at improving internal control. Internal auditing professional standards require the function to monitor and evaluate the effectiveness of the organization’s Risk management processes. Risk management relates to how an organization sets objectives, then identifies, analyzes, and responds to those risks that could potentially impact its ability to realize its objectives. Some of the key risk assessment activities in organizations include: production planning, quality planning, incentive payout determination, credit authorization, and capital planning, each of which can be audited in one or more projects. It is an independent objective assurance and consulting activity designed to add value and improve an organization’s operations. It helps an organization to accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance process.


History of internal audit:

The Internal Auditing profession evolved steadily with the progress of management science after World War II. It is conceptually similar in many ways to financial auditing by public accounting firms, quality assurance and banking compliance activities. Much of the theory underlying internal auditing is derived from management consulting and public accounting professions. With the implementation in the United States of the Sarbanes-Oxley Act of 2002, the profession’s growth accelerated, as many internal auditors possess the skills required to help companies meet the requirements of the law.

The main objectives of the internal audits can be summarized as follows:

1. To assist the internal control system.

2. Review of organizational policies and their operations.

3. Verify the accuracy and authenticity of errors and frauds.

4. Detection and prevention of errors and faults.

5. Safeguarding the assets

6. Applicability of accounting policies.

7. Expense properly authorized.

8. Right disposal of assets and

9. Helps in smooth functioning of internal check system.


Internal audit system, if designed and implemented properly helps in different fields such as:

Regulatory management

Q.A. Managers and other employees

Government auditors.


Internal audit project involves the following steps:

1. Establish and communicate the scope and objectives for the audit to appropriate management.

2. Develop an understanding of the business area under review. This includes objectives, measurements, and key transaction types. This involves review of documents and interviews. Flowcharts and narratives may be created if necessary.

3. Identify control procedures used to ensure each key transaction type is properly controlled and monitored.

4. Develop and execute a risk-based sampling and testing approach to determine whether the most important controls are operating as intended.

5. Report problems identified and negotiate action plans with management to address the problems.

6. Follow-up on reported findings at appropriate intervals. Internal audit departments maintain a follow-up database for this purpose.

Designing of the Internal Audit System:

In a pharmaceutical facility for internal auditing, you require to check mainly two things namely,

Activities carried out by different departments and

Documents maintained by these departments.

For this purpose a department wise questionnaire and document list is required to be prepared in detail.


Implementing the Internal Audit System:

Ideally following steps should be taken to implement the audit system,

Constitute a small team of experts from various disciplines e.g. Q.A. / Q.C., Production, Validation, Engineering, Personnel etc.

Provide initial training to all team members on carrying out the audit activity.

Generally the head of Q.A. should be the chairman of this team.

Fix an audit schedule (time table) and communicate to all concerned people.

Carry out the audit of each area of activity at least once in six months.

Report the audit findings to the concern department and seek their time bound compliance.

Report to top management on observed deficiencies and corrective actions planned.

Follow up and take further corrective actions if required.

Repeat the audit as per pre-planned schedule.


How the Department should prepare for Audit?

A practical approach which is taken in Pharmaceuticals industry is as follows:

First divide all activities in sections and also defined the rooms (or physical or geographical areas) and assigned the responsibilities of the complete compliance in each area to a person, starting from production supervisor to production manager.

Then a detailed room wise checks list is prepared by each department head and discussed and handed over to their assigned people and asked them, that they will be totally responsible for all compliance in their areas.

Then the departmental manager are called and asked to look after all general or departmental requirements to meet the compliances and see that all the minor details in the area will be looked after by the junior staffs who were assigned each specific area.

This helps us tremendously since all the minor details in each area were looked into by the relatively junior staff and since they were large in number, the work load gets evenly distributed. Senior staff get sufficient time to look into more general and policy related work.

Generally we see that such divided work – type of system really helps in making the organizations more cGMP compliant.

2. External Audits:

These audits are audits carried by a company on its vendors or subcontractors. Even though there is no strict legal requirement for this audit. It is always advisable to evaluate the competence of the contractors where we produce our products or carry out analysis of our products or any such other activities.


External audits are audits carried out by a company on its vendors or subcontractors. There is no strict legal requirement to conduct such audits, but the need is implicit, since manufacturers are required to have a thorough knowledge of their suppliers. Furthermore, if work is contracted out, they must ensure that contractors are competent to complete it, in accordance with GMP.

There are also strong business benefits to be derived from performing these audits:

building knowledge and confidence in the partnership arrangement

ensuring that requirements are understood and met

enabling reduction of certain activities (e.g. in-house QC testing of starting materials)

reducing the risk of failure (and, by implication, its costs)

The scope of these audits will vary, depending on the relationship between the two parties, which may range from a simple vendor-purchaser transaction to a strategic joint venture partnership. Confidentiality and technical agreements are likely to influence this.

Typically, there will be an initial evaluation audit of the capabilities and general suitability of the vendor/contractor. Subsequently, regular audits will be carried out to assess compliance with agreed contractual standards, the frequency of which will depend on the initial findings and the criticality of the vendor and materials supplied. As confidence in the vendor increases – through auditing, confidence in the vendor’s own internal auditing systems, third-party audits and vendor history – it should be possible to reduce the level of external auditing.






External auditors typically have a broad practical experience of GMP and receive quality systems auditing training equivalent to that of ISO 9001 lead auditors. Audit teams may also include specific technical experts. Depending on the size of the facility and the scope of the audit, an audit team of one or two other people will usually accompany the audit leader.






Many pharmaceutical industry suppliers are ISO 9001 or ISO 9002-certified and are regularly audited by their certification body. Pharmaceutical contract manufacturing or packaging companies will need to be licensed and will be subject to regulatory audits.

External audit programs typically focus on financial reporting and associated processes and matters that might result in material weaknesses, financial internal control weaknesses, or misstatements that compromise a bank’s financial statements.


External Audit Function:







An external audit program encompasses engaging an independent auditor to perform a full-scope finance audit, documentation audit, an attestation of internal controls over operations reporting, or other agreed-upon external audit procedures. Outsourced or co-sourced internal audit activities are not considered part of an external audit program.

An effective external audit function often provides the board of directors and management with:

• Reasonable assurance about the effectiveness of internal controls over operating systems, the accuracy and timeliness in recording various activities, and the accuracy and completeness of required regulatory reports.

• Information useful to directors and management in maintaining a quality, operations and risk management processes.


Appointment of external auditors:
The auditions for appointment of external auditors should have sufficient technical and managerial exposure by way of formal qualifications and practical experience related to pharmaceutical industry operations.


Assessment of the external audit:
The management, at least on an annual basis, shall obtain and review a report by the external auditors describing (or meet and discuss the following with them):

The audit firms internal quality procedures

Any material issues raised by the most recent internal quality control review of the audit firm, or by any inquiry or investigation by the governmental or professional authorities, within the proceeding five years, respecting one or more independent audits carried out by the firm, and any steps taken to deal with such issues.

All relationships between the external auditor and the company.
In addition, the committee shall set clear hiring policies for employees or former employees of the external auditor in order to prevent the impairment or perceived impairment of the external auditor’s judgment or independence in respect of the company.


Scope of the external audit:

The management shall discuss with the external auditors the overall scope of the external audit, including identified risk areas and any additional agreed-upon procedures. The management shall also review the external auditor’s compensation to ensure that an effective, comprehensive and complete audit can be conducted for the agreed compensation level.


3. Regulatory Audits:

These audits are carried out by regulatory bodies against relevant regulations for the manufacturer and supply of pharmaceutical products. International regulatory bodies such as M.H.R.A. (UK), U.S.F.D.A., T.G.A. (Australia), M.C.C. (South Africa) etc. are responsible for carrying out such audits.

Out of all these the organizations must strongly implement the system of internal audit after taking sufficient care for including all aspects of the organizational activities which are relevant to plant operations.

There is a team to carry out audit, should be comprised of audit inspectors & a multi-disciplinary company team. The company should have representatives from each of the following departments: Production, Quality Control, Warehouse, Maintenance, Administration /Personnel & Marketing/Sales.

These audits are carried out by regulatory bodies against relevant regulations for the manufacture and supply of pharmaceutical products. National regulatory bodies, such as the (MHRA) in the UK and Food and Drug Administration (FDA) in the USA, are statutorily responsible for carrying out such audits. All licensed pharmaceutical manufacturers periodically receive them (as may their contractors). These audits may be unannounced (MHRA currently performs about ten per cent of its UK inspections like this) as manufacturers are expected to be complying with GMP at all times. Regulatory bodies from other countries in which products are sold may also audit companies (i.e. FDA audits European manufacturers).

Regulatory inspectors are extensively trained and are knowledgeable and professional. All MHRA inspectors are relevantly qualified and have a minimum of five years’ appropriate experience in a manufacturing operation; they will be on the registers of persons eligible to act as qualified persons (QP) and lead auditors.

Failure to pass a regulatory audit can lead to restrictions on (or the withdrawal of) a manufacturing or import/export licence. (FDA has recently imposed punitive financial ‘consent decrees’ on companies which failed to respond adequately to audit findings and comply with GMP). Therefore, it is vital that companies have defined processes for handling audits and that staff are well trained as auditees. Internal audits can provide valuable practice opportunities.


Currently, different regulatory bodies have distinct audit styles and requirements, but to reduce costs and the audit burden on manufacturers, there have been moves towards sharing and mutually recognising audit findings between these bodies, a practice likely to increase in the future.


There has been a Pharmaceutical Inspection Convention (PIC) since 1971. Based in Geneva, PIC is open to any member of the UN that satisfies PIC officials of its adequate legislation and inspections relating to medicinal products. Under PIC, the health authorities of member countries agree that, if the manufacturer consents, information obtained during inspections may be exchanged. PlC holds regular meetings for the representatives of member countries to discuss common standards.

Launched in November 1995, the pharmaceutical inspection co-operation scheme is an informal, flexible arrangement between the inspectorates of PIC contracting states, which is run in parallel with PlC and is open to inspectorates from other countries. The scheme retains and improves on the convention’s main features:


  • networking and confidence-building between national inspection authorities
  • development of quality systems
  • training of inspectors and related experts
  • work towards global harmonisation of GMP


The European Agency for the Evaluation of Medicinal Products (EMEA) has an inspection and enforcement division, with a role in sharing inspection information between EU member states; it also helps to co-ordinate inspections outside the EU and is working on mutual recognition agreements (MRAs) between the EU and nonEU countries.

Regulatory audits vary considerably in scope, frequency and duration. Audits by the national regulatory body are likely to be regular and to cover systematically all areas of a facility, over a period of time. There may be additional audits (or visits) as a result of specific events, which may be company-specific (for example, the recall of a product) or industry-wide (a recent example being checks on compliance with transmissible spongiform encephalopathy regulations by the MHRA).

Audits by the regulatory body of another country may be general, or linked to a specific regulatory event: the pre-approval inspections of the FDA are linked to submission of a new drug application. Depending on the scope, up to three inspectors may visit, for a period of between half a day to two weeks.


After a regulatory audit, a formal report will be delivered, the format of which will depend on the regulatory body concerned: MHRA provides verbal feedback at the exit meeting, then a brief, action-orientated, written report shortly afterwards; FDA provides a ‘form 483’ at the exit meeting, if there are points of concern, followed by a more detailed establishment inspection report. The regulatory body will expect a timely, formal response to the audit report and typically, will check that corrective action has taken place, as part of the next audit. It is wise business practice to take regulatory audit findings seriously and ensure that timely and effective corrective action is taken.


Preparing a Quality Audit:


Procedures should cover all aspects of work where conformity and standards are required to achieved desired quality levels. For example, one might decide to control formal program testing, but leave the preliminary testing of a prototype to the programmer’s discretion.


Any recurring aspect of work could merit regulation. The style and depth of the description will vary according to needs and preferences, provided it is sufficiently clear to be followed.


A major tenet is that the defined procedures are good and will lead to the desired levels of quality. Considerable thought, consultation and trialing should be applied in order to define appropriate procedures. Procedures will often also require defined forms or software tools.


As with any good quality management, the procedures should be properly controlled in terms of accessibility, version control, update authorities etc.


All participants need to know about the defined procedures – that they exist, where to find them, what they cover. Quality reviewers are likely to check that team members understand about the procedures.


The defined procedures should be followed. Checks will be made to ensure this is the case. A corrective action procedure will be applied to deal with shortcomings. Typically the corrective action would either be to learn the lesson for next time, or to re-work the item if it is sufficiently important.

Operating a Quality Audit:

A Quality Audit approach affects the entire work lifecycle of a pharmaceutical industry:

§ Pre-defined standards will impact the way the project is planned

§ Quality requirements for specific work packages and deliverables will be identified in advance

§ Specific procedures will be followed at all stages

§ Quality Methods must be defined and followed

§ Completed work and deliverables should be reviewed for compliance


How to conduct the audit?

1. To conduct an audit the audit team has the authorization to review any record that they deem necessary.

2. The entire team should as much as possible try to work together during the audit.

3. The audit team walks through every section of the plant & carefully reviews every paper, record or area that is specified in the formal audit questionnaire no matter how familiar one member of the team is with the questionnaire item or the area.

4. Each record, procedure & report is challenged. A good tip is to retrieve all forms, records & samples of a given batch selected randomly from one of the batches made within the last six months.

The following things that should be challenged for the selected batch in the audit:

Manufacturing record & procedures

Dosing/filling record & procedures

Raw materials analytical forms

Packaging material analytical forms

Bulk product report

In-process control record

Final product record

QC recording books

Warehouse recording books

Purchase orders for raw materials, packaging components & miscellaneous

Materials stock control bin cards

Production & QC equipment log books

Final product bin card

5. The questionnaire is used to help the team to monitor adhernce to the GMP. Each qestion is answered Yes or No according to the current actual status observed by the audit inspector during the audit & not according to the intent or future plan.

6. Under the obeservation/comments section, notes should be recorded of status of conditions as a guide for improvements to be recommended.

For devepoling the plan of audit engagement (projects) based on a risk assessment, Internal Audit standards requires. The input of senior management and the Board is typically included in this process. Many departments update their plan of engagements throughout the year as risks or organizational priorities change.

This effort helps to ensure the audit activity is aligned with the organization’s objectives, by answering two key questions: First, what goals is the organization trying to accomplish in the upcoming period? Second, how can the Internal Audit Department assist the organization in achieving these goals?

Internal auditors often conduct a series of interviews of senior management to identify potential engagements. Changes in people, processes, or systems often generate audit project ideas. Various documents are reviewed, such as strategic plans, financial reports, consulting studies, etc. Further, the results of prior audits and resolution of open issues are considered. For example, even if a business area is important, prior audit work and the nature and status of open issues may render further audit effort unnecessary. If the organization has a formal enterprise risk management (ERM) program, the risks identified therein help limit the amount of separate risk assessment performed by Internal Audit.

The preliminary plan of engagements is documented and prioritized. Audit resources and expertise are then considered and a final plan is presented to senior management and the Audit Committee. The presentations vary based on the needs of the stakeholders but typically include the following:

Summary of key goals, risks and corresponding major audits, to illustrate alignment;

Analyses of audit effort along a variety of dimensions along with commentary regarding changes;

Brief description of critical projects identified;

Projects requested but not planned for execution due to prioritization and resources;

Required co-sourcing effort, typically where outside expertise is required or during peak periods; and

Appendix materials, such as planning approach, assumptions (e.g., days per auditor and staffing level) and brief descriptions of all planned audits and related prioritization.

Practice in the measurement of the internal audit function involves a balanced scorecard approach. Internal audit functions are primarily evaluated based on the quality of counsel and information provided to the Audit Committee and top management. However, this is primarily qualitative and therefore difficult to measure. “Customer surveys” sent to key managers after each audit project or report can be used to measure performance, with an annual survey to the Audit Committee. Scoring on dimensions such as professionalism, quality of counsel, timeliness of work product, utility of meetings, and quality of status updates are typical with such surveys.

Quantitative measures can also be used to measure the function’s level of execution and qualifications of its personnel. Key measures include:

Plan completion: This is a measure of the degree to which the annual plan of engagements is completed, measured at a point in time. This may be measured using the number of projects completed, weighted by the planned size of each project, with estimates for projects in-progress. Measured throughout the year, it is compared against the percentage of the year elapsed.

Report issuance: This is a measure of the time elapsed from completion of testing to issuance of the final audit report, including management’s action plans. This can be measured in average days or percentage of reports issued within a certain standard, such as 30 days. Establishing expectations for the timing of management’s response to report recommendations is critical. In addition, the scope and degree of change involved in the report’s action plans are key variables.

Issue closure: Reported audit findings are often called “issues” or “deficiencies.” Professional standards require audit functions to track reported findings to resolution, which effectively requires the maintenance of an issues follow-up database. The number of days that reported issues remain open, or open after their agreed-upon closure date, are key measures. In addition, reporting database statistics such as the number of issues open (unresolved), closed (resolved), and issues opened/closed during a given period are useful statistics.

Staff qualifications: This can be measured through the percentage of staff with professional certifications, graduate degrees, and overall years of experience.

Staff utilization rate: This is measured as the percentage of time spent on projects, as opposed to administrative time such as training or vacation. Many internal audit departments track time by audit project.

Staffing level: The number of positions filled relative to the authorized staffing level. Due to the challenge of finding qualified staff, departments may have rotational programs to bring in management to complete tours in the function or be “guest” auditors. Audit departments also “co-source,” meaning they obtain contract auditors from service providers.

For the reporting of critical findings the Chief Audit Executive (CAE) typically reports the most critical issues to the Audit Committee quarterly, along with management’s progress towards resolving them. Critical issues typically have a reasonable likelihood of causing substantial financial or reputational damage to the company. For particularly complex issues, the responsible manager may participate in the discussion. Such reporting is critical to ensure the function is respected, that the proper “tone at the top” exists in the organization, and to expedite resolution of such issues. It is a matter of considerable judgment to select appropriate issues for the Audit Committee’s attention and to describe them in the proper context.



  1. Internal audit From Wikipedia, the free encyclopedia.
  2. Audit From Wikipedia, the free encyclopedia.
  3. Pharmaceutical Industry Research Credit Audit Guidelines, Revised – 4/30/04.
  4.  Comptroller’s Handbook on Internal and External Audits, April 2003
  5. Juran’s Quality Planning Analysis for Enterprise Quality








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7 Responses to “Audit”

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Can u plz let me know the difference betweeen Audit and Inspection?


Exposure to how to conduct internal audit and
tools that are been used may be explined

good work…
this site is very helpful to us.

detailed information for anyone in the quality assurance arena

Kind attn: Mr.Manohar Potdar
Dear all,

I have gone through article on types of audit & their details component.Very informative & Very great usefull for pharma proffesionals.

Manohar sir, we intracted in Esvee pharma there i was Manager QA.Now i am DGMQA in sterling group of companies inpune

Rajendra Patil

Thanks for Knowledge sharing,
Can i have quetionare on audit of WHO Geneva

Dear Tejas,

I dont have a soft copy of Questionnire of W.H.O. but abooklet which we have designed , which covers this . if you want one Ican send it toyou at nominal price ofRs.200only.

Send M.O. and your address


PoonaCollege Of Pharmacy Erandwane, Paud Road PUNE 411038 Maharashtra

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