I m rasika walunj from modern college of pharmacy moshi doing my m.pahrm in QAT deliver a seminar on quality assurance audits

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