Dear kawan….kali ini andy akan membahas jenis –jenis validasi proses yang ada di industri farmasi. Jenis validasi proses antara lain :

1. Prospective validation

2. Retrospektive validation

3. Concurrent validation

Prospective Validation

Validasi terhadap pembuatan yang diterapkan sebelum produk di release di pasar. Validasi ini dilakukan dari menentukan bentuk sedian sampai pengajuan price harga. Biasanya dibutuhkan minimal 3 batch untuk menunjukkan hasil yang diharapkan

Penerapan validasi ini secara berurutan adalah :

  • Formulasi program/optimasi formula

pada formulasi program ini pertama dilakukan pada skala laboratorium (3000-5000 tablet jika tablet yang diformulasikan, 2-5 kg jika sedian padat/semi cair, 3-5 L jika sedian cair). Setelah bagus, maka dilakukan Pilot project (minimal 10 % dari ukuran batch komersial). Selanjutnya adalah proses scale up yang merupakan ukuran batch komersial

  • testing /challenging

Sesungguhnya step ini dilakukan pada saat skala laboratorium, pilot project, skale up berlansung. Pada tiap tahap tersebut dilakukan pengetesan dan perubahan formula untuk memperbaiki formula.

  • Bahan baku yang digunakan di catat.

  • up scaling

setelah melakukan sampai proses scale up, maka kita sudah siap untuk memproduksi tingkat komersial

  • Master produktion document

Setelah formulasi scale up telah lengkap, maka kita memiliki dokument yang disebut master produktion dokument. Yang harus dicatat disini antara lain nama produk, produk diskription (diameter tablet, ketebalan tablet, berat tablet, kadar za, dll), formula, material to be use (semua bahan yang diperlukan untuk analisis), produk shelf life (expired date), safety precaution(sedian disimpan pada suhu berapa, dll agar tidak rusak), pengemas (penanda spesifik agar tidak palsu giman).

  • Master produktion prosedur
  • formal spesifikasi

Untuk formal spesifikasi, disini di jelaskan spesifikasi –spesifikasi raw material yang digunakan. karena kita tahu, bahwa berbeda suplier raw material, terkadang menghasilkan produk yang berbeda. Misal saja sodium sulphate sebagai bahan pengisi deterjen produksi Purwakarta kualitasnya lebih buruk daripada made in china guandong. Akibatnya, deterjen yang dihasilkan juga berbeda. Maka dari itu, jika bahan baku ada yang ganti , terkadang harus ada validasi retrospektif kembali. namun pada kenyataannya ???

  • validation program and study
  • Registration for marketing authorization
  • Comercial sale production

 

alasan memilih validasi prospective karena :

a. data tidak lengkap (lama pencampuran, lama pemutaran)

b. Uji in process control tidak seluruhnya dilakukan (tidak tuntas)

c. Dilakukan sebelum proses produksi (preproduktion/prerelease)

d. terdapat alat dan komponen baru. kenyataannya yang divalidasi hanya yang diganti saja.

Pharmaceutical manufacturing Asosiasition menyarankan produk steril harus selalu menggunakan prospective validattion.

Retrospektif Validation process

dalam validasi ini, produk telah dipasarkan. Yang dimaksud telah dipasarkan adalah produk yang diproduksi dan dipasarkan telah lebih dari 20-50 batch.

PT. Gelannggang Farmasi, Menugaskan untuk melakukan validasi produk yang sudah beredar. Setelah melakukan kajian 20 batch,-30 batch. susunan tim validasi biasanya antara lain manager pengawasan mutu, manager produksi, manager litbang, dan manager teknik.

Memilih validasi retrospektive karena :

a. obat sudah beredar dulu tapi belum divalidasi. Validasi dilakkan dengan megnambil sampel dari dsetiap batch kemudian dilakukan pengujian.

b. validasi ini dilakukan untuk produk yang sudah lama beredar sehingga sudah mendapatkan kepercayaan.

datanya lengkap, sehingga memberikan gambaran yuang lebih baik dan tingkat kepercayaan lebih tinggi.

FDA menerima retrospekctive validation dengan syarat:

a. Uji khusus dengan metode analisis yang terpercaya

b, dokument tersedia lengkap

c. variable proses (raw material, kontrol lingkungan, kontrol mikroba, proses pembuatan, metode analisis, spesifikasi) terkontrol dan terstandarisasi.

Dengan demikian, dapat dijadikan sebuah kriteria apa saja validation retrospektive itu, yakni :

a. tidak ada penyimpangan formula

b. telah direlease lebih dari 20 batch –30 batch

c. metode uji sama

d. tidak ada perubahan prosedur pembuatan

sehingga apbila team validasi memutuskan untuk melakukan validasi retrospektive maka syarat validasi ini harus memenuhi kriteria : produk sudah dipasarkan dan team validasi menemukan bahwa tidak ada penyimpangan formula, alat sama, metode uji sama, dan tidak ada pengubahan prosedur.

 

menurut FDA biasanya retrospective validation digunakan untuk bentuk sediaan solid. yang di validasi retrospective antara lain :

a. Diagram alir proses (flow chart of the process)

b. Data dokument sebelumnya untuk produk dan proses (general historycally data for product and process)

c. sumber dan karakteristik raw material

d. hasil uji in proses control

e. keseragaman kandungan

f. formula induk

g. Complaints

sedangkan untuk sediaan steril, FDA menyarankan menggunakan prospective validation.

 

 

 

Concurent Validation

Validasi yang dilakukan dalam suatu proses yang belum tervalidasi sebelumnya sampai pada tahap komersial atau jika validasi prospective tidak memiliki data yang lengkap, atau validasi yang dilakukan saat mengalami perubahan implementasi saat proses sudah berlangsung.

 

jadi, gampangnya validasi ini :

a. produk sudah dijual tapi belum menerapkan validasi

b. sudah prospektive validation tapi dinilai kurang memuaskan hasilnya

c. adanya perubahan tapi tidka perlu dihentikan (mixer ganti, maka yang divalidasi kerjanya saja)

d. produk yagn jarang diproduksi atau diproduksi 3 batch tapi tidak berturut –turut.

 

 

 

 

soal -soal

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 perubahan formula, alat tidak berubah, sudah berjalan/direlease min 20 batch, tidak ada perubahan prosedur, metode uji sama.

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

Jawab:

a. validasi yang dilakukan: validai prospektif.

b. alasan:

– karena setiap pekerjaan yang dilakukan harus pada kondisi yang steril dan aseptis baik proses produksinya maupun linkungannya.. (bener ra yo temen-temen????)bapaknya bilang apa ya???kemarin?

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