Good Manufacturing Practice ( GMP)

2701.jpgSeperti yang sudah saya bahas di tulisan sebelumnya mengenai standar organik, sekarang giliran saya akan bahas standar industri makanan olahan, atau produksi farmasi yang rasanya farmasi banget ! Yaitu Good Manufacturing Practice atau terjemahan bahasanya, Cara Pembuatan Obat yang Baik ( CPOB), pertama untuk terjemahan ini, saya juga merasa aneh, kok ada “obat”nya, perasaan di perkataan asal nggak ada kata “ drugs” sama sekali, aneh. Ya, memang aneh, karena sebenarnya istilah GMP akan memiliki 3 kategori yaitu GMP for Drugs ( standar tertinggi, untuk proses produksi farmasi berupa obat), GMP for Food ( standar untuk proses produksi farmasi yang berupa makanan ), dan GMP for Cosmetics ( standar untuk proses produksi farmasi yang berupa kosmetik).

Jadi, begini ceritanya, jangkauan industri farmasi sebenarnya memang menyangkut 3 jenis industri besar yaitu obat, makanan,dan kosmetik ( kalau saya sih, bidang pabriknya di nomor 2 dan 3, lebih asyik, hehe…Soalnya, saya nggak suka bidang “kesehatan”, sukanya bidang “kelezatan” dan “kecantikan”, suiit… ). Industri farmasi bukan melulu soal obat dan berbau perawatan kesehatan, tetapi juga makanan, apa contohnya? Formulasi makanan yang melibatkan farmasis di dalamnya adalah : Teh Botol Sosro ( Dosen saya nih, Pak Iwang Soediro alm. namanya), minuman suplemen Red Bull, minuman Root Beer-nya A& W, formulasi makanan bayi Nestle,dan minuman Coca Cola. Nah kan ? Jadi, industri makanan pun, standarnya adalah, standar farmasi, begitu….( Tetap, buat saya, Say No To Drugs! Penginnya sih, bikin sediaan inhalasi ( lewat saluran pernapasan) dalam bentuk rokok, buat kesehatan, yoi, bingung gimana caranya ya ? Semisal, buat yang sakit flu, sediaan obatnya dalam bentuk cerutu Kuba rasa kopi Starbuck, kan asyik tuh!)

Cerita eh cerita, begini jalannya, ini salah satu versi penjelasannya :

Good Manufacturing Practice or GMP (also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.

Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself. An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).

In the US, the phrase “current good manufacturing practice” appears in 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351). US courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.

Secara alur kerja, bisa disederhanakan sebagai berikut :

gmpflow.gif

15 comments

  1. mas Galih..ko ada dian sastronya suuittt….

    *PS : akurlah dengan isi tulisannya

  2. Assalamualaikum WR WB

    @ Amir : Mbak Dian itu “cantik” , kalau pakai fotonya Mbak Nurul Izzah Anwar, lha wis ono bojone je Mas, gak enak. Maunya ya foto istri saya sendiri, masalahnya, aku durung duwe bojo je, rak yo mbingungi mengkono ta ? Halah…Bisa mencarikan saya istri ? Sebelum saya jatuh cinta nih, halah lagi….

    @ Hegar : Saya jawab via email ya….Semoga zukzez

  3. ayu

    ass. wr. wb.

    izin ngelink ya pak !!

    tetap semangat !!!

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  5. @ Bu Ayu Hilmawati, S.Si, Apt, ya, semangat juga. Apa kabarnya ? Silakan di link, btw, punten kalau susah curhat, makanya blognya kata teman saya “arogan ” begini ( aduh…)

    @ Ibu Tita, baik, semoga manfaat.

  6. Hegar

    Mas klo cari kualifikasi mutu Jahe dimana ya?trus apa aja sih yg masuk dalam kualifikasi mutu itu?makasih

  7. @ Hegar, khusus untuk jahe, sudah ada SNI Jahe, akan saya kirimkan via email. Sukses

  8. Widiyanto

    Selamat Malam,
    Bisa minta tolong untuk di informasikan referece standard International dari standar PKRT yang dikeluarkan badan POM. Terima kasih

  9. gensri

    hm….mo tau lebih banyak tentang GMP boleh? masih awam bgt nie ttg GMP

  10. waaah…saya jadi ingat ujian GMP (farmasi industri), mas…

    dosennya bikin deg-degan…, slalu bikin jantungan…

    (lho, koq sy jadi curhat ya? hehe, ‘afwan)

  11. wahyu

    Mas, dimana ya bisa training GMP Farma di Jakarta ?

  12. YUNI

    BISA MINTA INFO ALAMAT TRAINING GMP DI JAKARTA??? SAYA BERMINAT BGT…
    TRIMS

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