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Elemental Impurities ICH Q3D: Data and reality

The implementation of ICH Q3D has already become in a reality, and the requirements and implementation dates represent a challenge for the pharmaceutical industry. Based on the document ‘Implementation strategy of ICH Q3D guideline’(EMA/CHMP/QWP/115498/2017 – Committee for Medicinal Products for Human use (CHMP), there are two different approaches to risk management of elemental impurities in drug products: drug product approach and component approach.

The immediate question is: ‘What is the best option for my company?’ The answer is not that straight forward; there are several points to consider! First, it should be noted that, as stated in the previously mentioned document, the use of the component approach is encouraged due to its advantages from a scientific and transparency point of view. However, the drug product approach might be a better option in certain cases (when time is the most critical parameter). A combined strategy can be also considered: start with component approach and, when necessary, cover data gaps by testing elemental impurities in the finished drug product to demonstrate compliance in due time by the product approach.

Elemental Impurities ICH Q3D: Data and reality

Resources (analytical equipment, personnel, economic, time) are critical parameters to consider. Without a prior planning and a good optimization of the resources, the overall cost of ICH Q3D implementation can be increased to significant levels.

Therefore, the aim of this document is to describe our experience with representative real examples of our customers, through comparison of the estimated and the actual costs of the implementation of ICH Q3D.

 

Company

Portfolio

Estimated cost ()1

Approach2

Number of analysis required3

Actual Cost ()4

Project duration (months)

Savings (%)

Generic drugs manufacturer

110

275,000

C

18

90,000

12

67,3

Multinational innovative MAH

20

50,000

DP

20

45,000

2

10,0

Small size manufacturer

6

15,000

C

1

7,500

2

50,0

R&D Department (Licensor)

12

30,000

CS

7

18,000

3

40,0

Large size CDMO

60

150,000

CS

12

70,000

7

53,3

Generics & OTC manufacturer

80

200,000

C

6

70,000

9

65,0

Small size OTC manufacturer

15

37,500

CS

5

22,000

3

41,3

Large size CMO

100

250,000

C

9

90,000

11

64,0

Medium size CDMO

34

85,000

C

0

24,000

7

71,8

Medium size CMO

40

100,000

C

7

36,000

7

64,0

Manufacturer and MAH

25

62,500

C

2

25,000

6

60,0

Large size CDMO

77

192,500

C

3

53,000

12

72,5

Manufacturer (MAH) and CMO

40

100,000

C

7

42,000

8

58,0

Medium size CMO

35

87,500

CS

11

58,500

6

33,1

Parenteral drug manufacturer

40

100,000

C

9

55,000

8

45,0

Multinational MAH

12

30,000

DP

12

24,000

1

20,0

Small size manufacturer/MAH

11

27,500

C

2

16,000

3

41,8

Medium size CMO

22

55,000

C

2

28,000

5

49,1

MAH (outsourced manufacturing)

14

35,000

CS

9

25,000

3

28,6

1: Estimation based on the analytical cost and time required for the risk assessment.

2: C: Component; DP: Drug product; CS: Combined strategy.

3: Number of products and/or components that have required experimental testing by customer.

4: Approximate result based on the price of Azierta and the actual analytical costs.

The implementation by the component-approach is the most cost-effective option, with an average saving of 59.4% compared to the estimated cost.

The statistics show that bigger companies (in terms of number of products) can take more advantage from a good planning (average 64.4%).

 The component approach will generally require more time than the product approach. This fact is reflected in the following graph showing the average time (in months) required for finishing the risk assessment of 10 products.

As overall conclusion, the optimization of resources can lead to very important savings while keeping a high-quality standard: A good planning is the key for a successful implementation in a reasonable time with a reasonable cost!

Our experience demonstrates that the component approach is a cost-effective solution for the implementation of ICH Q3D. It provides high-quality risk assessments at a significantly reduced cost.

If you want more information please visit www.azierta.eu

Or contact us by email: palonso@azierta.eu

Authors: Ignacio Jorge & Paulino Alonso. Azierta

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