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Audits
Mr.Prasenjit Mondal
M.Pharm, (Ph.D), AIC.
Associate Professor.
Dept Of Pharmaceutical Analysis and QA
Vaageswari College of Pharmacy
Karimnagar. A.P
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Audits
A systematic, independent and documented process for obtaining
evidence and evaluating it objectively to determine the extent to which
criteria are fulfilled.
QUALITY AUDIT :
Quality audit is defined as a systematic and independent examination to
determine whether 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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Mr.Prasenjit Mondal, M.Pharm (Ph.D), AIC.
Associate Prof. VCP. Karimnagar

GMP Compliance Audit
• It is the audit related to Good Manufacturing Practice in
Pharmaceutical Industry
• Applying to national or international GMP Regulations.
• It can be define as an audit conducted by someone external to
your organization with the purpose of discovering GMP
deficiencies.
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Objective of the Quality Audits
 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 .
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Self Inspection
Principle
 To evaluate the manufacturer’s Compliance with GMP
in all aspects of production and Quality control.
 Designed to detect any shortcomings in the
implementation of GMP and to recommend the
necessary corrective actions.
 Performed routinely as well as on special occasions, e.g.
in the case of product recalls or repeated rejections
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Items of Self Inspection
 Personnel
 Premises including personnel facilities.
 Maintenance of buildings and equipment
 Storage of starting materials and finished products
 Equipment
 Production and in-process controls
 Quality control
 Documentation
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 Sanitation and hygiene
 Validation and revalidation programmes
 Calibration of instruments or measurement systems
 Recall procedures
 Complaints management
 Labels control
 Results of previous self-inspections and any corrective
steps Taken
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Types of Quality audits
The quality audit system mainly classified in three
different categories:-
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Carried out by…….
1. Internal Audit
* Staff of section or
department of
company
OR
* Local Quality
assurance Group.
2. External Audit
•A company on its
vendors. Or
Sub contractors.
3. Regulatory Audits
Regulatory Bodies
*MCA (UK).
* USFDA(USA)
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Internal Audit
Internal (First Party) Audits:
 A key purpose of an internal audit is hopefully to identify minor
problems and errors before they become a major issue or are
discovered by a third party.
 To Ensure that adequate Quality systems are maintained.
 To asses compliance with the C-GMP’s and firms standard
operating procedure.
 To achieve consistency between manufacturing and testing
facilities.
 To identify problems internally and Correct problems prior to a
FDA inspection.
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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.
• Documents maintained by these departments
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Implementing the Internal Audit system
Constitute a small Team Of Expert
Provide initial training
Fix Audit Schedule (carried out at least once in a six
month)
Report the audit finding and Report given to the top
management and shows corrective action
Repeat the audit as per preplanned Schedule.
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External Audit
External Audit ( 2nd Party):-
(A second party audit is one that is carried out by a non-regulatory
auditor).
For example, in some industries, especially pharmaceuticals and
chemicals, customers and potential customers will often ask to visit a
company :-
-- to ensure they are operating according to a quality
system and hence will provide good quality goods.
Purpose:
 Confidence in the partnership arrangement .
 Ensuring that requirements are understood .
 Enabling reduction of in-house QC testing of starting materials .
 Reducing the risk of failure.
 Carried Out by a company on its vendors or sub contractors .
 No legal requirement for to conduct audit.
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Purpose cont…..
 Regular audits will be carried out to assesses compliance with
agreed standards .
 Confidence in vendor auditing.
 Reduce level of external auditing.
 External auditors have experience of GMP and as well as
regularly audited by their certification body.
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External (Third party Audit) Or
Regulatory Audit
A third party audit is one that is carried out by a
Regulatory auditor or Inspector.
(These are a legal requirement in highly regulated
industries such as pharmaceuticals and food
production)
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Purpose of Regulatory Audits.
 Networking and confidence-building between national
inspection authorities .
 Development of quality systems
 Work towards global harmonization of GMP.
 Carried out by regulatory bodies such as MCA(U.K),
USFDA (USA) for manufacturing and supply of
pharmaceutical product .
 Audits may be unannounced .
 Failure of regulatory audit withdrawal of a manufacturing
or import/export license.
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Cont…
• After regulatory audit, a formal report will be delivered
For MCA :- verbal feedback report is given at
the exit meeting.
For USFDA :- Provides “Form 483”is given at
the exit meeting.
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This sort of audit is also a requirement for any
company accredited to a formal quality system
such as ISO 9000 or ISO 14000.

ROLE OF GMP AUDITS IN Q.A AND Q.C
PROGRAMMES
What is to be audited:-
 Auditors review.
SOPs
Employees Practices and behavior.
 Compare master specifications against compendia and
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 .
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Benefits which are derived from Audits are given as:-
.
.
.
1. Assuring GMP
compliance.
2. Detecting Potential
Problems.
3. Effecting Programmed
improvement.
4. Increasing management
awareness.

1. Assuring GMP Compliance
 FDA conducts routine inspections of all pharmaceutical
manufacturers to determine if manufacturing and
control procedures conform to GMP.
 FDA investigators make unannounced visits to the
manufacturing facilities to examine facilities ,
equipments, personnel and records.
 Use systemic analysis approach .
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2. DETECTING POTENTIAL PROBLEMS
GMP audits find objectionable condition that is
unknown to responsible production , QC ,QA or
management personnel.
The auditor will see whether such actions are
frequent or not .From this he can signal other GMP
problems.
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3. EFFECTING PROGRAMME IMPROVEMENTS
• Changing SOPs.
• Modifying manufacturing equipment or
procedure.
• Upgrading equipment or procedure.
• Improving employee training programmed
• Developing new or revised documentary system
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4. INCREASING MANAGEMENT AWARENESS
For any given audits there are two outcomes,
either problems are found or not .
If the problems are found , management takes an
appropriate step to eliminate the problem .
An audit is not finding any objectionable
conditions
Either there were no problems to be
found.
Auditor failed to detect objectionable
condition that were actually present.
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Preparation of Audit
 Dependant 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 interchange auditors from time to time for a
given area in internal audits.
 Contact with the auditee should be made well in advance of the
audit to allow adequate time for the necessary arrangements to
be made, and initial information gathering to take place.
 A Primary Contact within the Quality Assurance department of
the Auditee should be defined at the outset for a Customer or
Third Party Audit and regulatory inspection.
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Cont…
 The lead auditor or Inspector will then be in direct
communication to make the necessary arrangements and
agree the agenda in advance of the audit.
 When a pre-audit questionnaire should be studied
carefully by all relevant stakeholders, and clarification
requested as appropriate.
 Previous audit reports are another valuable source of
information. Similarly, discussing experiences, good and
bad, with recipients (e.g. internal customers in the case of
an internal audit; your raw materials testing laboratory in
the case of an external raw materials supplier audit) can
provide useful information such as batch/lot numbers for
challenging traceability.
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 The agenda for the audit should be communicated to,
and agreed with, the auditee. This could also identify
key reference documents (e.g. GMP; Quality Manual,
etc.) and relevant working documents such as
checklist(s), etc. to be used during the audit.
 The auditor should be aware of:-
a) Any sensitive issues (Highly Confidential
information )
b) Any conflict arise during the audit.
c) To handle the issues in a way that will
not jeopardise the relationship with the
auditee.
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Conductance of audit
 The audit should commence with an opening meeting to
introduce auditor(s) to relevant auditee staff and Senior
Management Representative.(especially relevant for an
external audit or inspection).
 The opening meeting also provides an opportunity to
to explain the audit rationale
clarify the audit plan.
agree communication channels .
clarify ambiguous replies in the pre-audit questionnaire.
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In the case of an external audit the opening meeting also
provides an ideal opportunity for
a) the auditee to explain Company rules
concerning, e.g. safety, taking photographs, confidentiality
of information, taking samples, talking with operators,
making recordings, etc.
 The auditor should decide in advance whether to use a
detailed checklist or 'Aide Mémoire' i.e simply rely on
memory and experience.
 The auditors should feel free to spend more time on
specific topics where compliance issues are becoming
apparent and so should used the Aide Memoire as a guide
from which the auditors can deviate if a concern arises
over an issue not covered by the checklist.

 During the audit it is usual to walk through relevant
parts of the facility to observe the operation at first
hand, to gather information, to assess the cleanliness
and condition of facilities and the risk of potential
contamination.
 All relevant observations should be recorded clearly
and concisely together with supporting evidence.
Concerns should be discussed with the auditee as they
arise to avoid surprises in the Closing Meeting.
 The selection starts with the determination of the major
areas the audit should focus on: production,
laboratories (both Quality Control and In-Process
Control), storage (raw materials, intermediates, APIs
and packaging), transport and distribution, engineering
and maintenance, development and Quality Assurance.
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In closing meeting:
The closing meeting is particularly important since it
allows the auditor (or audit team) to communicate the
audit findings and conclusions in a logical and co-
ordinated manner to the auditee‟s management.
 A simple agenda and a short written summary of
observations should be provide.
 It is important to emphasise the good news as well as
highlight the areas for improvement together with
supporting evidence.
 Audit deficiencies should also be classified to highlight the
priority for actions to the auditee and their Senior
Management.
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Audit Analysis
 Analysis should be done with the deficiencies…….
Deficiencies are classified as follows:-
1. Product Quality / Patient Safety Related deficiency (Critical)
2. Significant cGMP Deficiency but with no direct impact on Product
Quality /Patient Safety (Major)
3. GMP deficiencies that are either considered to be minor isolated
examples or there is insufficient information to classify them as
Major (Other)
 The auditee should be given the opportunity to clarify and fully
understand the evidence for the deficiencies.
 It is the auditors role to identify what needs to be achieved when a
problem is identified, in the case of Second or Third Party Audits
he/she should not be prescriptive in „how‟ to achieve it, although
advice may be offered, if specifically requested.
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Audit Report
It provides a record which identifies and may be useful for
prioritizing (e.g. Critical, Major, Other) areas for
improvement.
The audit report should be drafted, and the final version
issued, as soon as possible after completion of the audit.
There are two important reporting phases:-
i) Preliminary reports during the audit
ii) Final report to the management.
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Preliminary reports during the audit
1. Benefits can be gained from having dialogues with
employees.
2. Finding is communicated with affected personnel.
3. Discussion may help the employees to learn why
problems happened.

ii) Final report to the management.
 Management must review the final reports and
determine what steps need to be taken to eliminate
deficiencies .
 Management should sincerely encourage detection of
problems and express appreciation for being able to
improve quality operations.
 The audit reports may be shared with manger supervisor
who may discuss finding with employees.
 The workers and supervisory personnel should be given
the opportunity to explain their views and ideas about
the audit findings.
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Audit Follow Up
 Timely implementation of corrective actions, and
verification of their effectiveness,
 It is a good reflection to the auditees management is that
1st to start the major remedial action as soon as possible.
Followed by minor remedies.
 Major issues should be should be reported within a agreed
timeframe.
 It may also be necessary to re-audit to ensure that serious
remedial action has been satisfactorily completed for
Critical or Major deficiencies.
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