Overview QA
Quiz
•
Professional Development, Science
•
Professional Development
•
Medium
Quizz MBF
Used 8+ times
FREE Resource
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12 questions
Show all answers
1.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Merupakan aspek pemastian mutu?
Sistem mutu (SMIF)
Raw material
Proses produksi
Semua benar
2.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Tujuan & manfaat dari pemastian mutu, kecuali?
Menjamin produk yang dihasilkan berkualitas dan sesuai izin edar
Mencegah customer complaint
Mencegah recall product
Mencegah retur product karena penyimpanan di distributor
3.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Validasi yang biasa dilakukan oleh QA di industri farmasi, kecuali?
Process validation product
Cleaning validation
Validasi transportasi & sistem komputer
Analytical Method Validation
4.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Jenis kualifikasi yang dilakukan QA di industri farmasi, kecuali?
Kualifikasi mesin/ peralatan
Kualifikasi instalasi listrik pabrik
Kualifikasi sistem tata udara (AHU)
Kualifikasi sistem pengolahan air
5.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Perubahan berikut yang harus dilakukan sesuai prinsip change control management, kecuali?
Perubahan bahan baku obat
Perubahan ukuran kertas untuk mencetak Batch Record
Perubahan proses produksi
Perubahan prosedur pengoperasian mesin/ peralatan
6.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Badan regulasi untuk perizinan edar produk kategori PKRT adalah?
BPOM
BPJPH
KEMENKES
LPPOM
7.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Standar ISO 9001:2015 berlaku untuk?
Quality Risk Management
Quality Management System
Quality System Development
Quality, Safety, Efficacy
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