Presented by: K. Anupama M. Pharm [Q.A],1st sem

• • • • • • • • • • • • • Definition Objectives Principles of Auditing Types of Audits Audit life cycle Audit methods and techniques Role of GMP Audit in Q.A and Q.C Programmes Requirements of ISO Elements of a systematic Audit programme Audit team Reporting Audit Finding Benefits of Audit References

Definition of Quality Audit
• Quality audit is defined as “ A systematic and Independent examination to determine whether quality activities and related results comply with the planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.”

• Quality audit means a systematic of a quality system. • Quality audits are typically performed at defined intervals. • Any failure in their proper implementation may be published publicly and may lead to a revocation of quality certification.


• A first party audit is an audit performed by an organisation on itself i.e. an internal audit. • A second party audit is an audit performed by one organisation on its own behalf on another usually on a supplier by a customer. • A third party audit is an audit by an independent organisation other than the customer on a supplier.

Objectives of Quality Audit
Pharmaceutical manufacturers commonly audits as an effective mechanism to verify compliance with GMP regulation . • The general objectives of quality audit are as follows:  To determine conformity or non conformity of the quality system elements with specified requirements.  To determine the effectiveness of the implemented system in meeting specified quality objectives.  To afford an opportunity to improve the quality system.  To provide Managers with information.

Principles of Auditing
• The various principles of auditing are:  Ethical Conduct: The foundation of Professionalism, Trust, Integrity, Confidentiality and discretion are essential to auditing.  Fair Presentation: The obligation to report truthfully and accurately.  Due professional care: The application of diligence and judgment in auditing.  Independence: The basis for the impartiality of the audit and objectivity of the audit conclusions.  Evidence based approach: The rational method for reaching reliable and reproducible audit conclusions in a systematic audit process.

Types of Quality Audit
There are several types of audits: • Adequacy audit/ document review • Compliance audit/ on-site audit • External audit • Internal audit • Product or process audit

a) Adequacy audit/ Document review
• This is also known as system or management audit and is normally documented system represented by the quality manual and the associated procedures adequately meets the need of the applicable standard.

b) Compliance audit/ On-site audit
• This is the audit which seeks to establish the extent to which the documented system is implemented and observed by the workforce, i.e. are the people complying with the system?

c) External Audit:
• This is an audit that a company performs on its own suppliers or subcontractors. • Purpose of external audit: Confidence in the partnership arrangement. Ensuring that requirements are understood. Enabling reduction of in-house Q.C testing of starting materials. Reducing the risk of failure.

d) Internal Audit
• This is the most Important types of audits, which requires the company to look into its own systems, procedures and activities in order to ascertain whether they are adequate and being compiled with. • It provides the management with the information on whether or not their policies are being met, if the system is as efficient and as effective as it should be and whether any changes are needed. • It can provide a line of communication throughout the company and be a great motivator.

e) Product/ Process Audit:
• Product audit refers to an in- depth examination of a particular product/service to evaluate whether it conforms to product specifications, performance standards and customer requirements. • Process audit refers to an analysis of elements of a process and appraisal of completeness, correctness of conditions and probable effectiveness.

The Audit Life Cycle
• A Quality system audit can be broken down into four basic phases: 1. Planning 2. Conducting the audit 3. Analysis of results 4. Reports and corrective actions[including follow-up audits]

Audit Methods & Techniques
• Following are the types of audit method/techniques which are categorized based on the purpose of audit: 1. Horizontal auditing 2. Vertical auditing 3. Random auditing

1. Horizontal Auditing
• It involves examination of each functional area of an organization to verify adequacy and implementation of Quality.  System requirements: • Used for internal system auditing and second & third party assessment when it is necessary to establish if a basic QMS has been installed and is being implemented and maintained. • Each functional area is checked for conformance with quality system requirements, applicable to that area.

2. Vertical Auditing
• It involves examining functional areas of an organization that are actively contributing to a specific work package or contractual requirement.

3. Random auditing
• It examines the various aspects of an organization’s operation as determined by the auditor and due to the need to closely examine a particular actively or generally probe the system in arandom manner.

Role of GMP Audits in Q.A and Q.C programmes
• What is to be audited: Auditor’s review on SOPs employees’ practices and behavior  Compare master specifications against compendia & regulatory requirements.  Verify the test data and validation testing  Validation test reports are compared against raw data.  Verify corrective actions taken in reaction to audit finding.

Requirement of ISO:
• Audit procedure • An audit schedule that takes into consideration the audit area’s status and import results of previous audits. • Trained objective and impartial auditors. • An audit report including audit criteria, scope and methods. • Timely corrective action of deficiencies found. • Records that provide evidence that corrective action was implemented and its effectiveness was verified. • Results are reviewed by top management.

Elements of a systematic audit program
• Key elements: 1. Expectations and philosophies 2. Audit Formats and approaches 3. Checklists written criteria and SOP 4. Planned periodic frequency for audit 5. Specially trained personnel 6. Finding written audit reports

1. Expectations and Philosophies
• Senior management establishes the fundamental expectations of audit • Upper level management must establish the realistic goals and objectives. • Use of “ Formal Written Master Plan” approved by management.

2. Audit format and Approaches
• Manual GMP audit methods can be divided into following categories: i. Checklist format ii. GMP regulation approach iii. System analysis method

Checklist Format
• Use checklist as GMP audit guides and report finding. • Series of questions or instructions are grouped into logical order • Blocks may be used to record answer and space may be provided to make comments.

GMP Regulation Format
• The basic elements are derived from the following subparts of regulations:  Organization and personnel  Building and facilities  Equipments  Production and Processing controls  Production and packaging control  Holding and distribution  Lab controls  Records and reports  Returned and salvaged drug

System Analysis Method
• This method applies to potential problems likely to affect the quality of the product. • These FDA investigators describe the organized method for determining the potential problems.

3. Written Criteria & SOP
• This has to be established defining which audit data or elements are to be considered in the assessment of program performance. • Formal written SOPs should fully describe the details for carrying out the various audit functions like: • The responsibility for audit data review • Personnel responsible for recommendation • Decisions concerning corrective actions • Effective use of written criteria to ensure that conditions and practices remain under suitable state of control. • SOPs should be established.

4. Planned periodic frequency
• Each firm must establish the optimum time interval between audits based on several important factors like: -intended purpose -objectives, scope and depth -prior history of audit finding • Two types of Visits can be done depending on the type of audit: a) Announced Visit b) Un-announced Visit

5. Specially trained Personnel
• The following personnel factors deserve systemic attention: Defining audit or Qualification Documentation training skills & Experience Selecting audit teams Maintaining audit or awareness levels

Defining Auditor Qualification
• Auditors are selected based on: Their knowledge Their work experience in manufacture and Q.C as well as years of first hand dealing with GMP matters. • Essential Auditor skill includes awareness of: Firm’s SOPs and knowledge about its various departments

6. Documentation training skills & Experience
• There are usually 2 formats : Scientific principles Training under chemistry, engineering, statistics and pharmaceutics. • GMP: • GMP training may include the cumulative knowledge from reasonable years of experience. • This knowledge comes from; daily activities and formal training sessions.

Audit Team
• The personnel in the audit team are selected based on their experience and knowledge. • The team is required to cover many different systems and large amount of data. • Composition of team will vary depending upon the nature and scope of the audit. • Leader is usually a senior auditor who has extensive knowledge of the firm’s operations & has strong leadership qualities. • Tem size depends upon:  Firm size  Total number of products manufactured & control systems.  The audit objective

Reporting Audit Finding
• Audit reports should contain complete details of the program detected. • Corrective action is taken to eliminate problems and to measure the overall adequacy of the audit program. • There are two important reporting phases: 1. Preliminary reports during the audit 2. Final report to the management

Benefits derived from Audits
• The major benefits that are derived from Audits are as follows: Assuring GMP compliance Detecting potential problems Effecting programmed improvement Increasing management awareness

• Y. Anjaneyulu, R. Marayya; Quality Assurance & Quality management in Pharmaceutical Industry; Pharma Book Syndicate; Page no. 209-218. • http://wisqa.org/Archive2002/nov2002/i nternal%20auditing%20presentation/ppf rame.htm • http://www.authorstream.com/Presenta tion/13vinay-1177733-quality-audit/


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