Module 3 - Strategic case studies in practice

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WRAFT(.?N L A B· 0 R A T 0 R i E S

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PL 12063/0006

CONFIDENTIAL

A ;a}.PERRJGO® Company

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3.2.P.4

Control of Excipients - Paracetamol Capsules 500 mg

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Gelatin Ph.Eur is a Pharmacopoeial excipient and the specification, analytical procedures and validation procedures for this excipient are as specified in the European Pharmacopoeial monograph.

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3.2.P.4.5

Excipients of Human or Animal Origin

Gelatin is derived from animal sources which have been satisfactorily certified.

A TSE Ph.Eur Certificate of Suitability RO-CEP 2001-028-Rev 00 is now provided for an additional supplier of Gelatin.

The supplier is SU-HEUNG CAPSULE CO LTD EMBOCAPS 5TH, 7TH FLOOR

JUNGAN BLDG, 435-5 CHANGAN-3 DONG TONGDAEMUN-GU

SEOUL KOREA

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and the site of production is GELTECH CO LTD 1520-SONGJUNG-DONG

KANGSUKU SCO-PUSAN

The certificate is provided in Attachment 2.

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