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a PR3145 > LEC 1 > Flashcards

LEC 1 Flashcards

1
Q

Falsified medicines

A

Medicinal products/APIs with false representation

  1. name of manufacturer
  2. name of market authorisation
  3. batch number
  4. packaging/labelling
  5. identity/composition
  6. manufacturing records/certificates of analysis
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2
Q

Consumers put their trust in manufacturer & supplier & regulators to :

A
  1. weed out adulterated, counterfeits & falsified products
  2. to ensure safe & efficacious & quality products
  3. to oversee drug/API manufacturing & supply chain
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3
Q

PIC/S goal

A 
To lead the international 
1) development
2) implementation 
3) and maintenance 
of harmonised GMP standards (for manufacturers) & quality system (for inspectorates) in the field of medical products
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4
Q

GMP

A

Good Manufacturing Practice

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5
Q

PIC/S GMP chapters (9)

A
  1. Pharmaceutical Quality System
  2. Personnel
  3. Premises and equipment
  4. Documentation
  5. Production
  6. Quality control
  7. Outsourced activities
  8. Complaints & products recall
  9. Self inspection (IQA)
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6
Q

Complaints

A
  • a designated person should be responsible for handling complaints & deciding on actions to be taken
  • SOP on handling complaints should be in place
  • all complaints shall be recorded, investigated and closed out with decisions taken documented
  • all complaints records should be reviewed regularly for any recurring trend
  • Competent Authority (Regulatory Authority) should be notified if manufacturer is considering a product recall
    eg HSA
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7
Q

Product recall

A
  • a designated person, independent of Sales and Marketing, should be responsible for coordinating and executing the recall
  • SOP on product recall
  • distribution records should be readily available
  • Competent Authority (Regulatory Authority) should be notified if manufacturer is considering a product recall
    eg HSA
  • recalled products should be stored securely while awaiting decisions on its fate
  • progress of recall process should be recorded and final report issued, including a reconciliation between delivered and recovered products
  • effectiveness of recall procedure should be evaluated regularly
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8
Q

Where does adulteration occurs?

A

Occur at uninspected backyard manufacturing premises

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9
Q

Why are counterfeit products important to be identified? (3)

A
  1. Pose serious health risks
  2. Pose serious quality issues
  3. Patent violation
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10
Q

Backyard manufacturers (3)

A
  • cross-contamination
  • non-sterile
  • non-validated methods
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11
Q

QbA

A

Not applicable today anymore due to the rise of falsified medicines, adulterated and counterfeit products
Hence, cannot judge the quality of a product by its appearance or its presentation

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12
Q

How to ensure GMP compliance by manufacturers? (2)

A
  1. Medicines Act & HPA require manufacturer of medicinal products to comply with PIC/S GMP standards in order to obtain their manufacturer’s license
  2. Periodic audits of manufacturer’s compliance by HSA
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13
Q

5 areas of inspection during audits

A

4M 1P

  1. Machines
  2. Manpower
  3. Methods
  4. Materials
  5. Premises
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14
Q

Inspection of QC department

A
  1. Ensure the Head of QC is independent of other departments of the company (eg Head of Manufacturing)
  2. Validation of QC methods
  3. SOP for QC
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15
Q

If the company engage in outsourced activities, should the outsourced companies be inspected?

A

Yes

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16
Q

PQR

A

Product Quality Review

  • analyse trends in results
  • investigate with CAPA
  • based on root cause analysis
17
Q

CAPA

A

Corrective Actions & Preventive Actions

18
Q

Self Inspection

A
  • should be carried out at periodic intervals
  • inspection should be carried out in an independent and detailed way by a designated competent person from the company
    OR
  • outsource QC companies (external experts)
  • record QC reports and propose CAPA
  • statements of eventual actions taken should also be recorded
19
Q

20 Annexes of PIC/S GMP Standards

A 
Stipulates additional requirements for various :
- medicinal product
eg sterile products, biological products
- GMP-related matters
eg sampling, CSV
20
Q

Applications of PIC/S GMP Standards

A
  • all 9 chapters applies to all products

- not all 20 annexes are necessary

a PR3145 (14 decks)

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