Bagi kalian yang bekerja di pabrik Farmasi, penting untuk mengetahui requirements yang berlaku di industri farmasi. Salah satu requirements yang perlu diketahui adalah requirements ISO. Belakangan ini pabrik farmasi berlomba-lomba melakukan sertifikasi ISO. Guideline ISO juga sangat lengkap. Mulai dari cara produksi obat hingga cara-cara pengecekan kualitas udara ada disini.
Saya akan share soft file ISO yang saya punya. Semoga bermanfaat.
1. Buletin ISO: Cleanrooms Classification : download disini.
2. Cleanrooms and associated controlled environments : download disini.
3. Separative devices (clean air hoods, gloveboxes, isolators and minienvironments) : download disini.
4. Cleanrooms Test Methods : download disini.
5. Classification of air cleanliness : download disini.
6. Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 : download disini.
7. Annex 5 : Supplementary guidelines on good manufacturing practices for heating, ventilation and airconditioning systems for non-sterile pharmaceutical dosage forms : download disini.
8. WHO good manufacturing practices for sterile pharmaceutical products : download disini.
Semoga bermanfaat.
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