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PR3145 > Lecture 1 > Flashcards

Lecture 1 Flashcards

1
Q

What is the Goal of PIC/S?

A

To lead the international development, implementation and maintenance of Harmonised GMP standard (for Manufacturers) and Quality System (for Inspectorates) in the field of medicinal products

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2
Q

What does GMP stand for ?

A

Good Manufacturing Practices (cgmp is current GMP)

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3
Q

What is the purpose of GMP?

A

GMP is a quality system standard implemented by pharmaceutical manufacturters to help ensure that

  • a medicinal product is CONSISTENTLY manufactured and controlled
  • to the quality appropriate for its intended uses
  • As required by its market authorization (aka product license)
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4
Q

What are the 9 chapters of PICS GMP Standard

A
  1. Pharmaceutical Quality System (including product quality review and quality risk management)
  2. Personnel
  3. Premises and Equipment
  4. Documentation
  5. Production (incl packaging)
  6. Quality control (including Starting, intermediate and finished products)
  7. Outsourced activities (Contract manufacture and analysis) –> usually for specialised things like microbial testing
  8. Complaints and product recall
  9. Self inspection (internal quality assurance) –> PICS req manufacturer to self check
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5
Q

What is the conventional manufacturing flow?

A

input –> production and packaging –> Processes –> QC testing –> Output

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6
Q

What is checked during the input phase?”

A
  1. Warehouse
  2. Assess starting materials (APIs, packaging materials and finished products):
    - Approved specifications
    - Approved suppliers
  3. SOP in place for:
    - Receipt
    - Quarantine
    - sampling (incl availability of sampling room)
    - release of materials
    - handling rejected materials and products
  4. Environment (Temp, RH, pest control)
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7
Q

Which Chapters of the PICS to GMP is warehouse under?

A 
Chapter 3(premises: storage areas)
Chapter 5 (production: Starting materials)
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8
Q

What is the second place to be checked and why do we need to inspect it?

A

Weighing room.

  • -> Assess that calibrated, accurate and reliable balances are used
  • -> Weighed materials are of correct identity, qty and quality
  • -> Personnel wear appropriate PPE + env controlled to prevent cross-contamination
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9
Q

What are the 5 items covered during audit of weighing room?

A
  1. Calibration of weighing balances
  2. Labelling of starting materials
  3. personnel wear proper gowns and ppe
  4. SOP for weighing method
  5. Dust extraction system and housekeeping of weighing room
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10
Q

Which chapter is the weighing room under PICS guide to GMP?

A

Chapter 5 (production: dispensing)

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11
Q

What is checked after the weighing room

A

Production areas

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12
Q

Why is the production areas inspected? (5)

A

To asses that :

  1. Premises designed to prevent cross contamination
  2. Equipment effectively cleaned and regularly maintained
  3. personell control programmes that only allow restricted access to authorized personal to wear appropriate gowns and PPE
  4. Materials of correct IDENTITY , QTY and QUALITY are used for production
  5. Process controls are in place (e.g. Critical processes such as drying, granulation etc are validated. In-process QC in place, Bathc processing records kept)
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13
Q

Which Chapter does production department fall under in the PICS guide to GMP ?

A

Chapter 5 (specifically under production: paragraph 5.1 to 5.71)

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14
Q

What are the areas that are covered during the inspection of production department

A 
PMMMM: 
Premises (production room)
Machine (production equipment)
Method and Materials (production process and starting materials)
Manpower (personnel)
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15
Q

Outline the fishbone diagram

A

FIshbone diagram

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16
Q

what is inspected after the production department fall under in the PICS guide to GMP

A

QC department

17
Q

Why is QC department inspected?

A

1 . Trained analyst that have independent authority for head of QC (so no conflict of interest)

  1. QC method approved by HSA (Robust, sensitive, accurate, reliable). Must be seen from the records of analytical method validation and Routine QC test results
    - procedure in place for maintenance, calibration, status labeling and assuring integrity of equipment
    - Procedure in place for receipt, storage, security, record-keeping of test sample, reagent and reference standards
18
Q

Which chapter does QC department fal lunder in PICS guide to GMP?

A

Chapter 6: Quality control: paragraph 6.1 to 6.41

19
Q

What other areas and activities (3) are inspected?

A

Engineering workshop
Toilet/ Restroom
Corridoors

20
Q

What is the standard that external premises and outsourced activities have to adhere to and how does HSA want companies to enforce it?

A

ISO 17025 Certification by SPRING Singapore that is acceptable by HSA but need the company to have an express contract with the external vendor .

21
Q

What is the last step of the audit (after the QC)?

A

Documentation audit

22
Q

What is covered under the documentation Audit (4)

A
  1. Cover legal requirements
  2. Regulatory commitments
  3. Manufacturing SOPs
  4. Manufacturing records are AUTHENTIC

MAIN POINT –> MANUFACTURER CONFORMS TO LEGAL AND REGULATORY REQUIREMENTS AND PICS GMP STANDARD

23
Q

What are the standards for complaints (4) and products recall (1) for under chapter 8

A

Complaints:

  1. Designated person for handling complaints
  2. Written SOP
  3. Recorded, investigated and clsoed out
  4. Copmplaints reviewed regularly for trend

Recalls:
1. REgualtory authority should be notified if the manufactureer is considering product recall

24
Q

What are the criteria for self- inspection - chapter 9 ( 4)

A
  1. Carried out at periodic intervals and pre arranged programme
  2. Areas cover all the 9 chapter
  3. Independant person
  4. Can be external expert also
  5. Must be recorded
  6. Statement of eventual action taken should also be recorded
25
Q

What does the annexes cover?

A

Additional standards that may apply to some manufacturers

PR3145 (1 decks)

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