Plasma Products Lot Release

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Plasma Product Lot Release

Guidelines

Document Name	Updated
Slides Pembentangan Pilot Study Interim Report for Plasma Product Lot Release in Malaysia	14-Jun-16
Guidance Document for Plasma Product Lot Release in Malaysia 2nd edition 1 Dec 2016	Dec-16
Slides Pembentangan Taklimat PPLR 31 Julai 2015	31-Jul-15
Slides Pembentangan Taklimat Cold Chain 31 Julai 2015	31-Jul-15

Application Forms

Document Name	PDF	MS Word	Updated
Application Form Plasma Products Lot Release version 2			Nov-2016

Directives

Document Name	Upated
Direktif untuk Pelaksanaan Plasma Products Lot Release ke atas Semua Produk Plasma yang Berdaftar di Malaysia	29-Jun-16

PLASMA PRODUCT LOT RELEASE CERTIFICATES

NOTIFICATION OF NON-COMPLIANCE

Recent Updates

Cold Chain Inspection
published on 2018-09-25

Guideline on Good Distribution Practice (Third Edition, 2018)
published on 2018-01-01

Direktif untuk Pelaksanaan Plasma Products Lot Release ke atas Semua Produk Plasma yang Berdaftar di Malaysia
published on 2016-06-29

Good Manufacturing Practice/Good Distribution Practice
published on 2013-05-14

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.

Email: npra@npra.gov.my
Phone: +603-7883 5400
Fax: +603-7956 2924, +603-7956 7075

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DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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Site Last Modified

Last Modified: Friday 14 June 2019, 09:11:46.