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Lecture 5 (Audit) PDF

This document discusses quality auditing in the pharmaceutical industry. It defines quality auditing and outlines its purpose to systematically examine quality assurance systems and ensure compliance with good manufacturing practices. The key points covered include: - Components of quality auditing include personnel, contamination control, sanitation, premises, documentation, and audits. - Audits can be internal or external, and are conducted to build confidence and monitor suppliers and distributors. - Effective auditors require training, knowledge of quality assurance and manufacturing practices, communication and investigation skills. - The audit process involves planning, documentation review, reporting findings and corrective actions to improve compliance.

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64 views

Lecture 5 (Audit) PDF

This document discusses quality auditing in the pharmaceutical industry. It defines quality auditing and outlines its purpose to systematically examine quality assurance systems and ensure compliance with good manufacturing practices. The key points covered include: - Components of quality auditing include personnel, contamination control, sanitation, premises, documentation, and audits. - Audits can be internal or external, and are conducted to build confidence and monitor suppliers and distributors. - Effective auditors require training, knowledge of quality assurance and manufacturing practices, communication and investigation skills. - The audit process involves planning, documentation review, reporting findings and corrective actions to improve compliance.

Uploaded by

rana mokbel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Lecture 5 (Auditing)

QA1
Dr. Reham Samir Elezaby
Lecturer of pharmaceutics & industrial
pharmacy

1
Components of GMP
1 • Personnel
2 • Contamination control
3 • Sanitation & cleaning
4 • Premises
5 • Plant services & utilities
6 • Documentation
7 • Quality Audit
2
3
Quality audit
 Is a systematic examination of the QA System & its
parts → it determines whether activities comply
with planned quality arrangements → whether
these arrangements are implemented effectively to
achieve objectives

 Quality audit is extended to suppliers &


distributors

 Who conducts quality audit?


1. independent specialists (from outside the
company)
2. a team designated by the management
4
Types of quality audit
Internal External
(Self inspection) Regulatory
↓
↓ ↓
Done on external
Done on internal parties: Done by
departments of regulatory
1. Suppliers
the company organizations
(raw & packaging
(based on (FDA – WHO –
materials)
different Ministry of health)
strategies) 2. Distributors

5
 Self inspection
 Is conducted repeatedly by the manufacturer
(as part of the QA system) in order to:
 1.monitor implementation of GMP
guidelines (production + QC aspects)
 2. propose any necessary corrective
measures

 Records of self-inspections & any


subsequent corrective actions are
maintained

6
Reasons for quality auditing
A) INTERNAL
1. determine the level of compliance with GMP guidelines
2. build confidence in QA system
3. build inter-departmental trust & communication
4. determine measures to improve GMP components
e.g. premises, equipment, personnel
5. recommend corrective actions → monitor improvement

B) EXTERNAL
1. build mutual confidence, understanding & communication
between company & external parties
2. monitor capability of supplier to deliver materials &
services
3.7 monitor capability of distributor to deliver products
Auditing strategies
1. Forward trace: follow production flow from
receipt of materials → despatch
2. Backward trace: despatch → receipt
3. Product based
4. Documentation based
5. Problem based e.g. complains or recalls and any
corrective action taken
6. Department based

8
The Auditor
 What are the essential qualifications of a good
auditor?
1. Extensive training on auditing
2. Appropriate knowledge & understanding of
QA & GMP
3. Adequate personal skills: good observation &
listening abilities
4. An enquiring, yet, open-mind
5. Good communication skills
6. persistence, patience & diplomacy

9
 Auditor tools:
1. Documents:
- Quality/GMP regulations, standards & guidelines
(local, national & international)
- Previous audit & follow-up reports
- Auditee’s own documents & reports
- Audit checklists

2. The auditor’s own qualifications (eyes, ears,


thoughts, experience, training, … etc)

3. The auditing plan & program


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12
 Steps of a quality audit:
1. Plan date & time of audit
2. Prepare auditing documents: objectives of audit,
regulations & guidelines (to which company documents
will be compared) and checklist
3. Determine type of audit & auditing strategy
4. Obtain details of site to be audited:
- Site/area drawings - Personnel organisation charts
- Products - Quality manual
- Records of complains & recalls
- Reports of previous audits & follow up records
5. Announce to auditee
6. Arrive at site of audit → opening meeting
7. Perform audit → concluding summary session
8. Construct formal audit report (with recommendations)
13
9. Follow up
Opening meeting
 Is more formal at an external than an internal
audit
 An agenda for this meeting is:
1. Introductions (audit team & auditees)
2. Auditors explain purpose & objectives
3. Meet auditor escorts
4. Agree on program/timing

Concluding summary session


Is an opportunity for:
1. Auditors to outline their findings and
recommendations
2. Auditees to comment and offer
explanations

14
Self-inspection program

15
Audit report
 A suggested structure for an audit report is:
1. Site/area audited
2. Date/time of audit
3. Auditors
4. Objectives/purpose of audit
5. Personnel encountered (names & positions)
6.Changes since previous audit (e.g. premises,
equipment, procedures, products, etc)
7. Observations (in a logical order)
8. Corrective measures requested
9. Oral responses of auditees
10.
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Final conclusions
 Follow-up
Starts at the concluding summary session, with
the oral requests made by auditor → must be
confirmed by written auditor requests to the
company management → this is followed by
written assurances from auditee that
requested corrective actions have been taken

 Corrective action report:


Is a way for:
1. Requesting action (auditor)
2. Receiving information on action taken (auditee)
3. Keeping track of any follow-up required
17 (auditor)
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