Tunga metaller / Heavy metals - SARQA · Tunga metaller / Heavy metals - En snabb historisk...

Tunga metaller / Heavy metalsICH Q3d & Farmakope

Rolf Arndt Cambrex Karlskoga

Tunga metaller / Heavy metals

Rolf Arndt

© 2011 Cambrex Corporation. All rights reserved.

-Quality Assurance Cambrex Karlskoga

- Svenska Farmakopekommitten / Working Party HM

Locations:Charles City, USA HQ, East Rutherford, USAKarlskoga, SwedenTallinn, EstoniaWiesbaden, GermanyMilan, ItalyHyderabad, India

A member of a global GroupCambrex Karlskoga is a member of Cambrex Corporation:• Formed in 1981• Headquarters in New Jersey, USA

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


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


Rolf Arndt


-Quality Assurance Cambrex Karlskoga

- Svenska Farmakopekommitten / Working Party HM

Hur samarbetar Ph Eur och Myndigheter


- En snabb historisk tillbakablick

- ICH Q3 d

- Ph Eur 5.20 och 2.4.20

- Vad händer sedan för Ph Eur

- Exempel på utvärdering enligt ICH Q3d

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

Historisk tillbakablick / Tunga metaller

Historisk tillbakablick/ EMA Guideline

Historisk tillbakablick / EDQM

EDQMPharmEuropa 23:2 / 2011

Ph Eur, USP & JP

Ph Eur Method A – G

USP Method I - III


- En historisk tillbakablick

- ICH Q3 d

- Ph Eur 5.20 och 2.4.20



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

ICH Q3d / Heavy metals

ICH Q3d/ Heavy metals

Arsenik

Kvicksilver

Bly

Kadmium


Only Control what you have to control

and nothing else!




- ICH Q3 d

- Ph Eur 5.20 och 2.4.20



EDQM2.4.20. 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



• 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.



•PROCEDURESSAMPLE PREPARATION & MEASUREMENT

Preparation of sample solution. Acceptance criterion & Measurement system Acceptance criterion:

•VALIDATION REQUIREMENTSSPECIFICITY, LINEARITY, RANGE, ACCURACY, REPEATABILITY, INTERMEDIATE PRECISION, LIMIT OF QUANTIFICATION, LIMIT OF DETECTION (ONLY APPLICABLE TO LIMIT TESTS)

Including acceptance criteria



- ICH Q3 d

- Ph Eur 5.20 och 2.4.20



Vad händer sedan?

Vad händer sedan?

• 2.4.8 Heavy metals

• 2.4.2 Arsenic

• 2.4.10 Lead in sugar

• 2.4.15 Nickel in Polyols

•2.4.20 Determination of metal catalyst or metal reagent residues

Vad händer sedan?



- ICH Q3 d

- Ph Eur 5.20 och 2.4.20



Exempel / Tunga metaller

Tack för mig

Och

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Tunga metaller / Heavy metals - SARQA · Tunga metaller / Heavy metals - En snabb historisk...

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