Tunga metaller / Heavy metals ICH Q3d & Farmakope. Rolf Arndt Cambrex Karlskoga

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1 Tunga metaller / Heavy metals ICH Q3d & Farmakope Rolf Arndt Cambrex Karlskoga

2 Tunga metaller / Heavy metals Rolf Arndt -Quality Assurance Cambrex Karlskoga - Svenska Farmakopekommitten / Working Party HM 2011 Cambrex Corporation. All rights reserved.

3 A member of a global Group Cambrex Karlskoga is a member of Cambrex Corporation: Formed in 1981 Headquarters in New Jersey, USA Locations: Charles City, USA HQ, East Rutherford, USA Karlskoga, Sweden Tallinn, Estonia Wiesbaden, Germany Milan, Italy Hyderabad, India

4 Cambrex has a strong position Total focus on small molecule intermediates and active pharmaceutical ingredients (APIs) proprietary intermediates and APIs custom development and manufacturing services Niche business controlled substances generic APIs high energy high potency Diversified technologies

5 Cambrex Karlskoga API Manufacture Located in Karlskoga, Sweden, 250 km west of Stockholm 350 employees Extensive lab facilities, including kilo lab 10 production units, including 4 pilot plants Full-function company 2011 Cambrex Corporation. All rights reserved.

6 Tunga metaller / Heavy metals Rolf Arndt -Quality Assurance Cambrex Karlskoga - Svenska Farmakopekommitten / Working Party HM 2011 Cambrex Corporation. All rights reserved.

7 Hur samarbetar Ph Eur och Myndigheter

8 Tunga metaller / Heavy metals - En snabb historisk tillbakablick -ICH Q3 d - Ph Eur 5.20 och Vad händer sedan för Ph Eur - Exempel på utvärdering enligt ICH Q3d

9 Tunga metaller / Heavy metals - En snabb historisk tillbakablick - ICH Q3 d - Ph Eur 5.20 och Vad händer sedan för Ph Eur - Exempel på utvärdering enligt ICH Q3d

10 Historisk tillbakablick / Heavy metal - Infördes USP VIII (ungefär 100 år sedan) - Infördes i Tyska och Schweiz Pharmacopea - USP XII (1942) infördes Pb som standard och även Cu var av intresse To reduce the risk of intake of toxic metals by the patient and to ensure a high chemical quality of the pharmaceutical substance

11 Historisk tillbakablick / Tunga metaller

12 Historisk tillbakablick/ EMA Guideline

13 Historisk tillbakablick / EDQM

14 EDQM PharmEuropa 23:2 / 2011

15 Ph Eur, USP & JP Ph Eur Method A G USP Method I - III

16 Tunga metaller / Heavy metals - En historisk tillbakablick -ICH Q3 d - Ph Eur 5.20 och Vad händer sedan för Ph Eur - Exempel på utvärdering enligt ICH Q3d

17 ICH Q3d / Heavy metals The proposed new Guideline Q3D will provide clarification of the requirements for metals, which are included in the ICH inorganic impurities classification.

18 ICH Q3d/ Heavy metals

19 ICH Q3d/ Heavy metals Arsenik Bly Kvicksilver Kadmium

20 ICH Q3d/ Heavy metals

21 ICH Q3d/ Heavy metals

22 ICH Q3d/ Heavy metals Only Control what you have to control and nothing else!

23 Tunga metaller / Heavy metals - En historisk tillbakablick - ICH Q3 d - Ph Eur 5.20 och Vad händer sedan för Ph Eur - Exempel på utvärdering enligt ICH Q3d

24 EDQM DETERMINATION OF METAL CATALYSTS OR METAL REAGENTS RESIDUES General approach for the evaluation of metal catalysts or metal reagents residues in the substances for pharmaceutical use It is not possible to describe all suitable sample preparation and measurement methods. Therefore, all methods that fulfil the described requirements may be used. If no sample preparation and/or measurement method is described in the specific monograph, a suitable sample preparation and/or measurement method must be developed and validated

25 EDQM DETERMINATION OF METAL CATALYSTS OR METAL REAGENTS RESIDUES A system suitability test must be performed on the day of the analysis. Before the initial use of a method, the analyst must ensure that the method is appropriate for the samples and instruments used. This is accomplished by following a validation procedure for methods not described in the specific monograph or by a system suitability test for methods described in the monograph.

26 EDQM DETERMINATION OF METAL CATALYSTS OR METAL REAGENTS RESIDUES PROCEDURES SAMPLE PREPARATION & MEASUREMENT Preparation of sample solution. Acceptance criterion & Measurement system Acceptance criterion: VALIDATION REQUIREMENTS SPECIFICITY, LINEARITY, RANGE, ACCURACY, REPEATABILITY, INTERMEDIATE PRECISION, LIMIT OF QUANTIFICATION, LIMIT OF DETECTION (ONLY APPLICABLE TO LIMIT TESTS) Including acceptance criteria

27 Tunga metaller / Heavy metals - En historisk tillbakablick - ICH Q3 d - Ph Eur 5.20 och Vad händer sedan för Ph Eur - Exempel på utvärdering enligt ICH Q3d

28 Vad händer sedan?

29 Vad händer sedan? Heavy metals Arsenic Lead in sugar Nickel in Polyols Determination of metal catalyst or metal reagent residues

30 Vad händer sedan?

31 Tunga metaller / Heavy metals - En historisk tillbakablick - ICH Q3 d - Ph Eur 5.20 och Vad händer sedan för Ph Eur - Exempel på utvärdering enligt ICH Q3d

32 Exempel / Tunga metaller

33 Exempel / Tunga metaller

34 Exempel / Tunga metaller

35 Tack för mig Och????