Quality audits are systematic examinations to determine if activities comply with plans and regulations. Pharmaceutical manufacturers use audits to verify compliance with Good Manufacturing Practices (GMP). Audits have two goals - to verify manufacturing systems are controlled and to permit timely problem correction. Audits evaluate GMP compliance in production and quality control. They are performed routinely and in cases like recalls. Areas audited include personnel, facilities, equipment, production, quality control, documentation, and more. Audits are classified as internal, external, or regulatory. Internal audits ensure quality systems and identify pre-inspection problems. External audits reduce risk for partners. Regulatory audits build cooperation between authorities. Effective auditing requires qualified staff, documentation,

2.  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.

3.  Pharmaceutical manufacturers commonly use
audits as an effective mechanism to verify
compliance with GMP regulation (GMP).
 GMP audits with two important goals
1. Audis are intended to verify that
manufacturing and Control systems are
operating under a state of control.
2. Audits permit timely correction of potential
problems.
3. Audits can be used to establish a high
degree of confidence to remain under an
adequate level of control by managements

4.  To evaluate the manufacturer’s Compliance with
GMP in all aspects of production and Quality
control.
 Performed routinely as well as on special
occasions, e.g. in the case of product recalls or
repeated rejections

5.  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

6.  Documentation
 Sanitation and hygiene
 Validation and revalidation programmers
 Calibration of instruments or measurement
systems
 Recall procedures
 Complaints management
 Labels control
 Results of previous self-inspections and any
corrective steps Taken

7.  The quality audit system mainly classified in three
different categories:
 1. Internal Audits
 2. External Audits
 3. Regulatory Audits

8.  Purpose of Internal audit:-
 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

9.  In a pharmaceutical facility for internal auditing,
you require to check mainly two things namely
1. Activities carried out by different departments
2. Documents maintained by these departments

10.  Purpose of External Audit
 Confidence in the partnership arrangement
 Ensuring that requirements are understood
 Reducing the risk of failure
 Carried out by company on its vendors
 No legal requirement to conduct the audit
 External audit have experience of GMP as well as
regularly audited by their certification body

11.  Purpose of Regulatory audit:-
 Networking and confidence-building between
national inspection authorities
 Development of quality systems Work
towards global harmonization of GMP.

12. What is to be audited
 Auditors review
 SOPs
 Employees pracices and behaviour
 Compare master specifications against compendial
and regulatory requirements
 Verify the test data and validation testing
 Validation test reports are compared against raw
data

13.  Assuring GMP compliance
 Detecting Potential Problems
 Effecting Programme improvement
 Increasing management awareness

14.  Manual GMP audit methods can be divided in to
categories
 Checklist format
 GMP regulation approach
 Systems analysis method

15.  Use checklist as GMP audit guides and reporting
finding.
 Series of questions or instructions are grouped in
to logical order.
 Blocks may be used to record answer and space
may be provided to make comments.

16.  The basic elements are derived from the following
subpart of regulations
 Subpart B: Organization and personnel
 Subpart C: Building and facilities
 Subpart D: Equipment's
 Subpart E: Production and Processing Controls
 Subpart F: Production and Packaging control
 Subpart H: Holding and Distribution
 Subpart I: Lab controls
 Subpart J: Records and Reports
 Subpart K: Returned and Salvaged drug

17.  Formal written SOPs should fully describe the
details for carrying out the various audit
functions.
 Effective use of written criteria to ensure that
conditions and practices remain under a suitable
state of control
 SOPs should establish
 The responsibility for audit data review
 Personnel responsible for recommendations
 Decisions concerning corrective actions.

18.  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 visit Can be done depending on
the type of audit:-
1. Announced Visit
2. Unannounced Audit

19.  Announced Visits:
 Advanced notice is given before the audit.
 It is not persuasive for two reasons :
1) The employee covers up the problem.
2) The person makes major adjustment in their
behavior
 Benefits :-
 Audit efficiency is improved from advance
notification Necessary records may be organized
and retrieved in the preparation for the audit.
 Key personnel become available

20.  Unannounced Audits
 To view conditions and practices that is normal or
customary (representative) as possible.
 For observing employees behavior as well as
observation of equipment's and facilities. Benefits
:- Allows observation of normal condition and
practices

21.  The following personnel factors deserve systemic
attention :
1. Defining auditor Qualification Documentation
training skills and Experience.
2. Selecting audit teams
3. Maintaining auditor awareness levels

22.  Selected based
 On their knowledge
 Experience in manufacturing and QC principles as
well as years of first hand experience dealing with
GMP matters.
 Essential auditor skill is aware of
 Firm’s SOPs and Knowledge
 Integrated by various departments.

23.  Two formats
 Scientific Principles
 Training under chemistry, engineering,
statistical and pharmaceutics
 GMP
 GMP training may include the cumulative
knowledge from years of experience
 This knowledge comes from
 Daily activities
 Formal training sessions

24.  Limitations of Personnel audit :
 Experience and knowledge, which is individual.
 Emphasize on familiar issues as well as particular
area
 Team is required for cover many different
systems and large amount of data.
 Composition of team will vary depending upon
the nature and scope of the audit .

25.  Leader is usually a senior auditor who has
extensive knowledge of the firm’s operations and
exhibit strong leadership qualities.
 Team size depends upon
 Firm size
 Total no of products manufacturing and control
system
 Breath and depth of the audit.
 The Audit objective

26.  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 uses reports.
 There are two important reporting phases:-
 1) Preliminary reports during the audit
 2) Final report to the management

27. 1. Pharmaceutical Dosage forms: Parenteral
medication, Revised and Expanded. Edited
by Kenneth E.Avis,Herbert A.libermann and
Leon Lachmann,Volume –3, Second edition ,
Page no:-363-420
2. Quality Manual, D. H. Shah, First edition,
Page no:- 184-216