compliance Halal Keluhan, Penarikan, dan Pengembalian Produk Peraturan dan Ketentuan
Ririn Afrianti  | 

Drug and food supplement control are performed in a comprehensive way through pre-market and post-market control. Pre-market control is an evaluation in regards to quality, safety and efficacy of the product prior to Marketing Authorization granted. For product which contains particular ingredients sourced from pork or involves pork within its process, it is compulsory to include this information on the product label.

Post-market control aims to overlook quality, safety and efficacy consistency of the product, by performing random sampling towards marketed products, manufacturing and distribution facility audit, pharmacovigilance monitoring, label and advertisement monitoring. Sampled product will be further tested to discover whether relevant drug and food supplement still comply with the approved specification during pre-market evaluation.

Recently there are cases related with Halal guarantee involving 2 famous brand of drug which are Viostin DR (Manufactured by PT. Pharos Indonesia) and Enzyplex (manufactured by PT.Medifarma Laboratories),

Based on the result of post-market vigilance conducted by BPOM through sampling and testing towards pork DNA parameter, both products have been proven to be positively contaminated by pork DNA fragment. The sample product was Viostin DS (MA Number SD.051523771) batch no C6K994H and Enzyplex (MA number DBL7214704016A1) batch number 16185101. Therefore, BPOM has instructed them to stop the production and distribution for related batch number. Per February 5th 2018, PT Pharos has destroyed more than 20 ton of Viostin DS.

The Head of BPOM, Penny K.Lukito said that in the case of finding Pork DNA in Viostin DS and Enzyplex, it is indicated there is inconsistency of pre-market information and post-market result. The result of post-market shown that the products positively contaminated by Pork DNA while the pre-market data that was submitted to BPOM for registration purpose stated that the raw material sourced from…

Profil Penulis

Ririn Afrianti

Assistant GMP Consultant. Memiliki Pengalaman dalam Proyek Pembangunan Pabrik Farmasi, Production Planning, Inventory Control, Warehouse Management dan Quality Assurance, terutama di Fasilitas Pembuatan Produk Steril Onkologi. Bergabung dengan CMPlus Consulting Indonesia pada tahun 2017 sebagai Assistant GMP Consultant dan berperan sebagai kontributor Website GMP Platform Indonesia, manajemen validasi pembuatan conceptual design dan manajemen audit.

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