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
Guidance Document for Biological Lot Release (effective 1st January 2020)	13-Nov 2019
Slide-1 Pembentangan Taklimat Extension of Lot Release Activities 12 Nov 2019	13-Nov 2019
Slide-2 Pembentangan Taklimat Extension of Lot Release Activities 12 Nov 2019	13-Nov 2019

Application Forms

Document Name	PDF	MS Word	Updated
Application Form Plasma Products Lot Release version 2			Nov-2016
Lot Release Application form (New)			Nov-2019
Sampel Submission Application Form (New)			Nov-2019

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

More Links

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 24 January 2020, 10:51:12.