BAB I (SISTEM MUTU FARMASI) – MANAJEMEN RISIKO MUTU

BAB I (SISTEM MUTU FARMASI) – MANAJEMEN RISIKO MUTU NO VERSI ASLI VERSI TERJEMAHAN 1.12 Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied…

PIC/S BAB I (SISTEM MUTU FARMASI) – PENGKAJIAN MUTU PRODUK

BAB I (SISTEM MUTU FARMASI) – PENGKAJIAN MUTU PRODUK NO VERSI ASLI VERSI TERJEMAHAN 1.10 Regular periodic or rolling quality reviews of all authorised medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness…

PIC/S BAB I (SISTEM MUTU FARMASI) – PENGAWASAN MUTU

BAB I (SISTEM MUTU FARMASI) – PENGAWASAN MUTU NO VERSI ASLI VERSI TERJEMAHAN 1.9 Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant…

Revisi Aneks 1 EU-GMP : Pembuatan Produk Steril

Draft Aneks 1 EU GMP yang sudah lama dinantikan akhirnya telah dipublikasikan pada Desember 2017. Tentu saja banyak perubahan dan tambahan yang terkait dengan operasional proses pembuatan produk steril. Selain itu ada juga penekanan terhadap pemanfaatan teknologi baru dan lebih banyak penekanan terhadap penggunaan prinsip QRM (Quality Risk…

{SPECIAL ARTICLE} Indonesia New Drug Registration Overview

All drug products which will be marketed in Indonesia shall be registered to National Agency of Drug and Food Control (NADFC – or locally known as BPOM). Before BPOM issued Marketing Authorization for drug products, BPOM will perform Pre-Market Control to assess the efficacy, safety and quality of…

Manajemen Risiko Mutu: Apa yang dilihat Inspektor?

ICH Q9 merupakan pedoman utama yang menyediakan prinsip dan contoh tools dalam implementasi Quality Risk Management (QRM) atau Manajemen Risiko Mutu yang dapat digunakan terhadap beberapa aspek mutu. QRM sendiri memiliki peran yang sangat besar dalam Pedoman EU GMP. Misalnya di dalam Pedoman EU-GMP Aneks 16 tentang Sertifikasi…

{SPECIAL ARTICLE} Indonesian medical device regulation overview

In this report, below items related to registration of medical device in Indonesia are explained. Regulation to be applied for medical device in Indonesia. Classification of medical device and production certificates in Indonesia Common Submission Dossier Templates (CSTD) for each Medical Device Class The registration procedure, labelling and…

{SPECIAL ARTICLE} PRODUCT RECALLED DUE TO PORK CONTENT IN INDONESIA

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…