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Audit
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.
• Executive summary
• Standards, checklist, or other reference documents that were used during the
audit.
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.
Internal audit system, if designed and implemented properly helps in different fields such as:
− Regulatory management
− Q.A. Managers and other employees
− Government auditors.
Preparing a Audit: