Dear kawan…kali ini andy akan membuka harta karun yang andy dapat dari soft copy..

yang pertama adalah soal-soal farmasi industri..aku minta temen-temen, untuk ikut menjawabnya yaw…

Jelaskan alasan perlu dilakukannya validasi di industri farmasi (PSC 1 baru)

Jawab:

a. memenuhi peraturan pemerintah (dalam penerapan CPOB)

b. menjamin mutu obat

penerapan suatu proses yang sudah dipahami disertai pengawasan yang memadai danmeyakinkan kita akan mutu yang dihasilkan:

– peningkatan mutu

– – peningkatankonsistensi mutu

– – peingkatan percaya diri dan kepercayaan pelanggan/konsumen

c. penghematan biaya produksi

suatu proses yang telah divalidasi akan meningkatkan efektivitas produksi sehingga akan mengurangi atau menghindari biaya yang tidak perlukarena kegagalan yang terjadi didalam dan di luar pabrik.

 

Jelaskan alasan perlu dilakukannya validasi di industri farmasi (PSC 1 baru)

Jawab:

a. memenuhi peraturan pemerintah (dalam penerapan CPOB)

b. menjamin mutu obat

penerapan suatu proses yang sudah dipahami disertai pengawasan yang memadai danmeyakinkan kita akan mutu yang dihasilkan:

– peningkatan mutu

– – peningkatankonsistensi mutu

– – peingkatan percaya diri dan kepercayaan pelanggan/konsumen

c. penghematan biaya produksi

suatu proses yang telah divalidasi akan meningkatkan efektivitas produksi sehingga akan mengurangi atau menghindari biaya yang tidak perlukarena kegagalan yang terjadi didalam dan di luar pabrik.

2. suatu industri farmasi memproduksi sediaan injekasi perlu dilakukan validasi. Jenis validasi apa yang dilakukan?

Jawab:

a. validasi yang dilakukan: validai prospektif.

b. alasan:

– tidaktersedian data yang lengkap

– uji proses dan produk akhir tidak sesuai

Persyaratan sebelum produksi

– digunakan atau komponen baru

3. mengapa perlu dilakukan validasi ulang?|

Jawab:

Dilakukan validasi ulang karena:

a. apabila terjadi perubahan dalam komposisi validasi seperti:

– produk baru

– perubahan bahan awal

– perubahan sistem atau proses

– perpindahan peralatan

– prerbaikan besar atau turun mesin

b. validasi ulang dilakukan tiap 1-2 tahun walaupun belum terjadi perubahan.

4. industri farmasi memproduksi d\sediaan tablet parasetamol secara kempa langsung formula:

R/ parasetamol 300 mg

MCC 100 mg

Mg stearat 2 mg

Apakah paramerter kritis produksi tablet tersebut?

Jawab: parameter kritisnya (PSC I hal terakhir-1)

1. sieving mesh size RH, bulk density, tap density, ukuran partikel

2. mixing time, spedd/setting, mixer load keseragaman

3. lubrikan time, spedd/setting, mixer load RH, keseragaman

4. compression compression spedd, compression force keseragaman bobot, kekerasan,kerapuhan, waktu hancur.

5. jelaskan bahwa alasan penerapan validasi dii ndustri farmasi adalah untuk meningkatkan mutu obat!

Jawab:durung kejawab..mau jawab>???

6. Jelaskan tujuan proses validasi dalam pembuatan obat di industri farmasi dan contoh dalam penerapannya.

Jawab:

males njawab.

7. Asuatu foprmula dari suatu obat terdiridari obat dan kompoenen tambahan yang mempunyai sifat aliryang baik dan kompaktibiltas yang baik. Formula tersebut dibuat dengan sediaan tablet.

a. metode apa yang digunakan dalam pembuatan tablet?

b. tahap mana yang perlu divallidasi dan bagaimana cara validasinya?

Jawab:

a. kempa langsung

b. mixing, pencampuran. Cara validasi????

8. Suatu industri farmasi akan melakukan validasi terhadap suatu produk yang sudah diproduksi lebih dari 60 batch. Produk obat tersebut selalu dibuat dalam kondisi yang sama.

a. Validasi apa yang digunakan?

b. Apa syarat yang harus dipenuhi dari tipe validasi tersebut: diasumsikan telah dirilis ke pasar.

Jawab:

a. retrospektif

b.

* tidak ada penyimpangan pada formula

* setelah lebih dari 20 batch

* Alat harus sama

* metode uji sama

* tidak ada perubahan prosedur pembuatan

9. apa fungsi dari kerjaPPIC?

Jawab:

Fungsi:

Jembatab komunikasi produksi, peasaran, pengadaan, akuntansi’keuangan, penyimapnan R n D yang berfungsi sebagai penyediaan obat.

Kerja:

1. Sistemi nformasi

2. Perencanaan dan pengendalian produksi

3. pengumpulan data analisis

Menyusun rencana produksi

5. melaksanakan pengendalian produksi

10. Validasi dilakukan untuk apa?

Jawab:

Validasi dilakukan untuk:

a. mengurangi problem produksi

b. memperkecil kemungkinan kerja ulang.

Menjamin mutu obat

Meningkatkan kepercayaan

Meningkatkan efektivitas dan efisiensi kerja.

M,eningkatkan keuntungan bagi perusahaan

11. Sebutkan tahapan-tahapn dalam validasi.

Jawab:

Tahapan validasi meliputi:

Rencana induksi validasi

Protocol validasi

Pravalidasi (kalibrasi instrument, kualifikasi perlatan)

Validasi produk

Laporan dan kesimpulan validasi

Sertifikasi

12. Bagian mana yang bertanggung jawab dalam CPOB

Jawab:

13. Apak tujuan inspeksi diri dalam CPOB?

Jawab:

Menjaga mutu obat

Mencegah karyawan bekerja seenaknya

Untuk memperbaiki obat yang diproduksi

Untuk memberikan input kepada konsumen tentang obat yangberedar

Untuk menjawab pertanyaan kalau ada klaim dari masayrakat.

14. Apa maksud dan tujuan validasi dilakukan?

Jawab: PSC I lembar 7

Tujuan validasi: membuktikn bahw bahan, proses, prosedur, …., sistem, alat dan mekanisme yang digunakan padaproses produksi dan ……, mampu menghasilkan produk yang di inginkan secara konsisten.

15. apakah fungsi retain sample?

Jawab:

Retain smampel berguna untuk mengontrol kalau ada klaim dari konsumen sehingga mempermudah proses pemeriksaan tersebut. Dengan kata lain klaim tidak langsung diterima tetapi harus dicek dulu dengan produk pertinggal yang ada di pabrik.

Retain sampel akan disimpan selama 1 tahun atau 3- 4 tahun jika tidak ada ED.

16. Kenapa harus melaksanakan QA tidak hanya QC? Jelaskan dan beri contoh !

Jawab: PSC 1-2/XI

17. Apakah faktor-faktor yang mengganggu laminar air flow> berikan deskripsi LAF !

Jawab: PSC Pak Ban, 9

18. Jelasakan pembagian ruang berdasarkan kategori atau klas.

Jawab:

19. Aspek apa yang perlu dikaji untuk menjamin kualitas produk? New I:2

20. Kenapa personel sebagai asset utama?New 2-9, (6:4)

21. Apakah dasar penerimaan validasi retrospektif? (6-2)

22. Parameter yang digunkan untuk menilai proses produksi yang menghasilkan keajegan produk !

23. Masalah-masala yang terjadi pada pengemasan dantahap yang perlu divalidasi pada validasi pengemasan?

24. Apakh tujuan validasi danpenerapnnya? (New 1:4)

25. Apakah perlunya dilakukan validasi retrospektif??

Jawab:

Untuk mebuktikan bahw paproses tersebut menunjukkan hasil yang diharapkan.

26. Sebutkan tahap validasi peralatan.

27. Suatu serbuk memiliki fluiditas dankompaktibilyas yang baik. Apakahmetode yang sesuai. Tahapan pembuatan yang perlu di validasi,

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