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A systematic and independent examination to

determine whether quality activities and related
results comply with planned arrangements, and
whether these arrangements are implemented
effectively and are suitable to achieve objectives

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 To collect objective evidence to permit an informed
judgment about the status of the systems or product
being audited

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 Pharmaceutical manufacturers commonly use
audits as an effective mechanism to verify
compliance with GMP regulation (GMP).GMP
audits with two important goals
Audis are intended to verify that manufacturing
and Control systems are operating under a state of
control
. Audits permit timely correction of potential
problems.
Audits can be used to establish a high degree of
confidence to remain under an adequate level of
control by managements
Aide Mmoire Document supporting the
auditor(s) to conduct a structured audit.
Audit A systematic, independent and
documented process for obtaining evidence and
evaluating it objectively to determine the extent to
which criteria are fulfilled.
Auditee Persons from an organisation or
organisational unit being audited. Auditor A
person with the competence to conduct an audit.
Audit Team One or more auditors conducting
an audit.
Audit Unit An organisation or organisational
unit (e.g. departments, plants, sites) to be audited.
Communication Is a process of exchanging information
between two or more persons. Communication can be
verbal and/or non-verbal.
Competence The demonstrated ability to apply
knowledge and skills. Compliance, GMP Applying to
national/international GMP regulations. Compliance,
regulatory Applying to statements made in the
organisations own documents submitted to the authorities.
Critical Quality Attribute (CQA): A physical, chemical,
biological or microbiological property or characteristic that
should be within an appropriate limit, range, or
distribution to ensure the desired product quality.
Critical Process Parameter: A process parameter whose
variability has an impact on a critical quality attribute and
therefore should be monitored or controlled to ensure the
process produces the desired quality
 A pharmaceutical auditor job involves researching and
ensuring necessary corrective measures.
A pharmaceutical auditor will establish the best
internal control system for costing, suggest and
implement necessary/ corrective measures to ensure
best practices, and ascertain accuracy of product
costing.
A pharmaceutical auditor will work in close co-
ordination with plant accountants to have plant wise
cost analysis & related control reports of preparation
and various reports with respect to costing and
controls.
A pharmaceutical auditor will assess
capability of material supplier to produce,
manufacture, test package, and distribute
APIs and other materials in compliance to the
current GMP/GDP, industry standards,
regulatory expectations and requirements.

A pharmaceutical auditor will also audit for

completing cost audit in time and ensure
correct cost updating in the system for proper
valuation of inventory.
 Introduction
Pre-audit Information
Preparation
Performing the Audit
Reporting the Audit and Auditee Response
Follow Up Of Progress with Remedial Actions
Possible Audit Breakdown
Documentation
 Recommendations for compiling and handling
the audit report
Classification of observations
Archiving
 Determine the basis for the audit
Determine the feasibility of the audit
Review documents
Prepare the audit plan
Prepare work documents
 What is the purpose of the audit?
What is your role?
What are the standards?
What is the scope?
 Verify the extent of conformity of the
implementation of GMP, or
part of it
Assess the competence of the management system
to ensure
conformity with GMP requirements
Evaluate the effectiveness of the management
system in meeting
its specific objectives
Investigate an unusual event or incident to
determine facts,
recreate events, and/or determine causes or
Recognize areas for potential improvement
 Given the purpose or purposes of the audit,
you must decide what type of perspective to
adopt: data gatherer, judge, consultant, or
salesman.
Example: If your purpose is to examine an
incident, act strictly as a data gatherer and hold
back your decision and any comments you
might have until you are confident that you
have obtained all the significant facts.
 Having defined the audit objective, scope and
criteria, determine the feasibility of the audit.
Factors to be considered include:
Availability of adequate and suitable information
for planning the audit
Adequate assistance from the auditee and
Sufficient time and resources
Where the audit is not practicable, suggest an
alternative to the audit in consultation with the
auditee and in full respect of the governance
principles.
 Prior to the on-site audit activities, evaluate the
auditees records to determine the compliance of
the system, as documented, with audit criteria.
The documentation may include:
Relevant management system documents and
records
Applicable standards
Site master file
Registration files
Guidelines
 SOPs
Protocol or Project specific requirements
Previous audit reports
Adverse drug reactions and
Records of the company in relation to complaints
and recalls
When reviewing the auditees documentation,
create a checklist or aide mmoire of the points, to
be confirmed during inspection. If the
documentation is found to be insufficient, notify
the auditee and decide whether the audit should
be continued or suspended until documentation
concerns are resolved.
 When reviewing the auditees documentation,
create a checklist of the points, to be confirmed
during inspection. If the documentation is
found to be insufficient, notify the auditee and
decide whether the audit should be continued
or suspended until documentation concerns are
resolved.
 Now, prepare an audit plan to provide the basis
for the concurrence among the auditees and audit
team regarding the conduct of the audit.
The audit plan should include:
The audit objectives, criteria and any reference
documents
The audit scope, including identification of the
organizational and
functional unit and processes to be audited
The dates and places where the on-site audit
activities are to be
conducted
 The expected time and duration of on-site audit
activities
The role and responsibilities of the audit team
members and
accompanying persons
The allocation of appropriate resources to critical
areas of the
audit
Any audit follow-up actions
Review and discuss the plan with the audit client
and present to the auditee before the on-site audit
activities begin.
Resolve any objections by the auditee.
 Make sure that the plan is communicated to all
site personnel,
especially those whose areas will be audited
Clearly list the areas / systems / products to be
audited and list
specific dates for each of the audits
Logically establish and agree each audits
duration
Stick to the schedule dont loose credibility by
postponing audits
 Review the information relevant to the audit
assignments and prepare work documents as
necessary. Such work documents may include:
Audit checklists and audit sampling plans
Forms for recording information, such as supporting
evidence,
audit finding and records of meetings; and
Forms for documenting supporting evidence for
conclusions
reached by the auditors
Please note that the use of checklists and forms should
not limit the scope of audit activities which may
become necessary as a result of information collected
during the audit.
 Internal (First Party, Self)

This type includes audits by company employees,

consultants and contractors

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 External
i. Supplier Audit
Second Party
Customer employee(s) audit your company
or
Your employee(s) audit a company which
supplies your company with a product or
service

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ii. Independent Organization

Third Party Audit

A customer wants an audit of your company

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1. Compliance (do we comply with the standard)
Example: Desk audit of high level systems
2. System (the theory)
Example: Audit of Document Control
3. Process (the practice)
Example: Audit of any process (manufacturing)
4. Product (the result)
Example: Audit of finished products to fulfil
technical specifications

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1. Auditor: A person who has appropriate qualifications
and performs audits.
2. Client: A person or organization requesting the audit.
For internal audits, this is the Management
Representative.

3. Auditee: An organization, facility or person being

audited.

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4. Quality System: The organizational structure,
responsibilities, procedures, processes and
resources for implementing quality management.

5. Observation: A statement of fact made during an

audit and substantiated by objective evidence.

6. Nonconformity: The non-fulfillment of specified

requirements.

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7. Objective Evidence: Qualitative or quantitative
information, records or statements of fact pertaining
to the quality of an item or service or to the
existence and implementation of a quality system
element, which is based on observation,
measurement or test and which can be verified.

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 (A) Imposed upon
manufacturer or
supplier

Customer, or Third party (on

Regulatory potential customer behalf of
customer)

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(i) Internal (self-
(ii) External
inspection)

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 Internal (self- External
inspection)
Overall supplier
Departmental contract manufacturer
Product-orientated contract packager
System-orientated Of contract
warehouse/distributor

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 Determine the level of compliance
Build confidence (hopefully) in GMP and the QA system
Build interdepartmental trust, understanding, and communication
(if the audit is done properly and tactfully)
Determine measures necessary to improve, e.g.,:
Premises, equipment, environment
Operations, actions, procedures
Personnel/training
Provide a stimulus for improvement
Recommend corrective action
Monitor improvement
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 Establish and monitor capability of supplier or
contractor to deliver
goods and services that are fit for purpose (and on
time, and in the quantity required)
Build mutual confidence
Promote understanding and communication
between the parties involved (both sides can learn!)
And in general, as listed for internal

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 Arrange and
Follow-up announce

Formal report, with Arrive at site of

recommendations audit, meet, explain
purpose

Informal oral Perform

report of audit
finding
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examination of

1. established methods

2. instructions

3. work flow for processes

4. maintenance programs for production equipment

5. material handling

6. housekeeping around the work area

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 Here companys procedures are validated
Processes are sub-parts of a system.
Process audits are generally a part of larger system(s)
audit.
However , they can be performed independently
An internal audit may indicate need to perform a specific
process audit
Almost always, one or more other process(es) will interact
with any given process.
One very important issue to consider is the effectiveness of
communications between systems and/or processes.
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1. Documents
a. Quality and GMP regulations, standards, and guidelines
(local, national, and international)
b. Previous audit and follow-up reports
c. Auditees own documents and records
d. Audit checklists
requires that auditor evaluates a certain number of
procedures, plans and documents
2. The auditors own eyes, ears, brain, words, character, etc.
3. The auditing plan
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1. Is there a documented sanitation program?
2. Are the specifics of the program followed?
3. Are there standard operating procedures (SSOPs)?
4. Is a pre-operational audit conducted prior to production?
5. Are corrective actions taken in response to pre-op
findings?
6. What are the general conditions in the plant?
7. Are the floors, walls and ceilings in good condition?
8. Are the exterior structure and grounds maintained in a
condition to prevent contamination?

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