Lecture 5 (Auditing)

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

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 Components of GMP
1 • Personnel
2 • Contamination control
3 • Sanitation & cleaning
4 • Premises
5 • Plant services & utilities
6 • Documentation
7 • Quality Audit
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 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
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 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

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  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

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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

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 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

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  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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 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)
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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

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 Self-inspection program

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 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
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