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Audit Seminar

An audit is an independent examination of an entity's financial or quality systems to determine compliance. The objectives of auditing include determining conformity to requirements, effectiveness in meeting objectives, and opportunities for improvement. There are internal audits performed within an organization and external audits of suppliers. The audit process involves pre-audit information collection, preparation by assigning roles, performing the on-site audit including an opening meeting, reporting findings, following up on corrective actions, and addressing any issues. The lead auditor coordinates the audit team and ensures consistency in findings, reporting, and follow up. Audits of tablet manufacturing involve examining SOPs, personnel training and qualification records, facilities and maintenance, cross-contamination prevention, and air quality controls

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147 views5 pages

Audit Seminar

An audit is an independent examination of an entity's financial or quality systems to determine compliance. The objectives of auditing include determining conformity to requirements, effectiveness in meeting objectives, and opportunities for improvement. There are internal audits performed within an organization and external audits of suppliers. The audit process involves pre-audit information collection, preparation by assigning roles, performing the on-site audit including an opening meeting, reporting findings, following up on corrective actions, and addressing any issues. The lead auditor coordinates the audit team and ensures consistency in findings, reporting, and follow up. Audits of tablet manufacturing involve examining SOPs, personnel training and qualification records, facilities and maintenance, cross-contamination prevention, and air quality controls

Uploaded by

HARI HARA RAO GUJJAR
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Audit

Definition:
An audit is an independent examination of financial information
of entity, whether profit oriented or not; irrespective of its sizes or
legal form.
Objectives of auditing:
To determine the conformity or non conformity of the quality systems
in meeting the specified requirements.
To determine the effectiveness of implemented quality in meeting the
specified quality objectives.
To provide the audit team with an opportunity to improve the quality
system.
To meet the regulatory requirements.
To permit listing of audited organizations quality systems in a
register.
Types of Audit:
1.1 General Considerations:
A systematic or independent examination to determine whether
activities and related results comply with the planned arrangements
either implemented effectively and suitable to achieve desired
objecives.
1.2 Audit Classification:
From an API manufacturer’s point of view distinction between
audits is whether they are internal audit and external audits.

1.2.1 Internal Audit:

These may be subdivided into local audits individually


plants and departments or projects or corporate audits
performed by central auditing group in order to access
conformance with corporate politics or standards.
1.2.2 External audit:
External audits performed on suppliers or contractors are checks
against unknown environments of products or service. They
should evaluate if the GMP compliance status of a supplier is a
suitable for each internet purpose.
Audits also used to approve suppliers and contractors on-site.
Auditing is recommended for suppliers of key services, critical
raw materials, contractors used for out sourced manufacture of
API or intermediates
Steps in managing the Audit:
Pre- Audit information:
The collection, collation and analysis of relevant information is
an essential pre- requisite of successfully planned quality audit in
order to determine the type, scope and specific objectives of audit.
They should also be a clear business benefit to justify the cost, the
both auditor and auditee of undertaking the audit.
Preparation:
Dependent on the scope of the audit the audit team can be
composed of one or more auditors. If there is more than one auditor a
lead auditor should be assigned and responsibilities should be agreed.
It is advisable to inter change auditors from time to time for the given
area in internal audits. This will combine the benefits of a detailed
understanding of the areas /activities with the broader expertise and
experienced of different auditors.
Performing the Audit:
The audit should commence with an opening meeting to
introduce auditor to relevant auditee staff and senior management
representatives.
The opening meeting in the external audit also provides an ideal
opportunity for the auditee to explain company rules concerning e.g;
safety , taking photographs, confidentiality of information, taking
samples, talking with operators, making recordings etc.
Reporting the audit and auditee response:
It provides a record which identifies and may be useful for
prioritising (e.g; critical, major, other) areas for improvement it is
recommended that a draft of the report be supplied to the auditee for
comment and check on accuracy and to avoid misunderstanding
arising over observations and recommendations.
Follow up of progress with remedial actions:
While minor remedial actions may be followed up at the next
routine audit, progress with major issues should be reported with in a
agreed time frame. It may also be necessary to re-audit to ensure that
serious remedial action has been satisfactorily completed for critical,
major defeciencies.
Failure of auditee to actively progress major and/or serious actions
should be referred to senior management( in both companies in case
of an external audit).
Possible audit breakdown:
The breakdown of audit is exceptionally rare occurance. It may
be result of poor planning/ preparation, failure to be clearly define and
agree scope and objectives, an in-adequately trained auditor or one
lacking appropriate personal characteristics, poor communication
before and during audit, lack of commitment/ co-operation/
understanding on part of auditee.
Responsibilities of Lead Auditor:
The lead auditor takes a key role in the auditing process with the
number of tasks and responsibilities. He should:
Inform the auditees of the purpose of the audit and agree the audit
agenda.
Ensure that the agreed upon audit agenda is followed,
Co-ordinate the activities of other auditors, when auditing party
subdivides into distinct parties.
Ensure consistency throughout the audit.
Consolidate all findings.
Present the audit findings and classification to senior management at
the conclusion of the audit.
Auditing of tablet:
1. SOPs
1.1 Is a complete index and complete set of applicable SOPs
available in the department?
1.1.1 Are the index and the SOPs current?
1.1.2 Is the set of SOPs correctly organized according to the
index?
2. Personnel
2.1 Select three employees working in a department. Are their
training records up-to-date?
2.2 Have the employees undergone training in the following
areas during last year?
GMPs
SOPs
Tableting techniques
2.3 Question several employees about the operations they are
performing. Are they knowledgeable about their job
function?
2.4 Have the employees undergone qualification according to
the relevant SOP?
2.5 Are all employees attired according to the appropriate
garmenting SOP?
2.5.1 When necessary, do operators wear masks and gloves?
2.5.2 Are beard covers used?
3. Facilities:
3.1 Is the department maintained in a good state to repair?
3.2 Is the department neat and orderly with sufficient space for
equipment and operations?
3.3 Examine the area at the end of the day’s work. Is it left
neat and tidy?
3.4 Are all work areas clearly labelled with the name and the
batch number of the product being processed?
4. Prevention and cross contamination
4.1 Are doors closed all the time?
4.2 Is personnel clothing clean, unstained, and dust free,
including shoes?
4.3 Is there a shoe-cleaning device in the department?
4.4 Is negative pressure maintained in working areas at all
times during work?
4.4.1 Is there a record of the pressure?
4.5 what is quality of the air in the department (filter
designation)?
4.6 Are there approved SOPs for the maintenance of ceiling
filters?
4.7 Is dirty equipment covered prior to transfer to washing
room ?
These are the specific questions to be answered by the
manufacturers during audidting.

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