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Question 1

What is GXP? (Good practices)

Answer 1

quality standards and regulations for a specific field or activity. GXP addresses 2 important regulatory requirements which are accountability and traceability.

Question 2

Define accountability

Answer 2

the ability to demonstrate what each person has contributed to a product and when they contributed.

Question 3

Define traceability

Answer 3

refers to the need to be able to reconstruct the entire history of a product’s creation.

eg. Drug Master File (DMF), Device History File (DHF)

Question 4

Objective of GMP

Answer 4

sets the minimum requirements that manufacturers of pharmaceutical products must meet to assure that products are of:

1) High quality
2) Do not pose any risk to patient safety
3) Appropriate for intended use
4) Meet requirements of the marketing authorisation or clinical trial authorisation

Question 5

Under GMP, What makes a quality drug?

Answer 5

ISPE. Identity, Safety, Potency/purity, Efficacy

Question 6

Identity

Answer 6

The drug is what you say it is
Intended use is consistent with product label

Question 7

Safety

Answer 7

SOPs, change control, inspection and verification of raw materials, contamination-proof enclosures

Question 8

Purity

Answer 8

Gowning, cleanroom facilities, elimination of cross-contamination

Question 9

Efficacy

Answer 9

right dosage strength, consistent potency across lots

Question 10

Who regulates GMP?

Answer 10

1) NRAs (National Regulatory Agencies) regulate the manufacturing of pharmaceuticals and healthcare products.
Responsible for ensuring that products released for public distribution are evaluated properly and meet international standards of quality and safety.

2) Continuously update GMP regulations and guidelines and ensure timely adoption of updates regulations and guidelines by manufacturers.

Eg. FDA (USA), HSA (SG)

Question 11

What is cGMP? (Current Good Manufacturing Practices)

Answer 11

The part of a quality management system (QMS) which ensures that products are produced CONSISTENTLY of a HIGH QUALITY, appropriate for intended use, safe for consumption and meets marketing regulatory requirements.

Question 12

5 pillars of cGMP

Answer 12

People, Procedure, Products, Premises, Processes

Question 13

People

Answer 13

• Should follow procedures
• Should be trained
• Roles and responsibilities should be clear

Question 14

Procedures

Answer 14

• Should be documented and retained
• Critical process should be covered
• Deviations should be investigated and retained

Question 15

Products

Answer 15

• Methods should be followed for every step of manufacturing, packing,sampling, testing and retaining
• Specifications and standards should be available for the raw materials, excipients or any other material used in the process.

Question 16

Premises

Answer 16

• Should be designed in a way for ease of movement and prevent cross contamination
• Equipment within premises should be calibrated and validated with proper schedules and procedures for doing the same.

Question 17

Processes

Answer 17

• Critical steps should be identified
• Should be defined clearly
• Proper documentation should be carried out
• Robust change control procedures should be followed

Question 18

One example of QMS

Answer 18

Quality by design (QbD)

Question 19

4 aims of QbD

Answer 19

1) To achieve product quality specifications that are based on scientific data and performance.
2) To improve process capabilities and reduce product variability by enhancing product and process design, understanding and control.
3) To increase product development and manufacturing efficiencies.
4) To enhance root cause analysis and change control management

Question 20

QbD in 5 steps

Answer 20

1) Quality target product profile (QTPP) that identifies the critical quality attributes (CQA) of the drug product
2) Product design and understanding through identification of critical material attributes (CMA).
3) Design process snd understanding of critical process parameters (CPP) and linking CMAs and CPPs to CQAs during the scale up process.
4) Control strategy that includes specifications for the

Question 21

Define QMS

Answer 21

A formalised system governed by a set of rules that documents processes, procedures, records and responsibilities for achieving quality policies and objectives.

Question 22

Consequences of not producing GMP compliant product?

Answer 22

1) Loss of life
2) Product recall
3) Drug with no effect
4) Global healthcare burden