Farmasi Industri
Produksi
Bagian produksi bertugas untuk
menjalankan proses produksi sesuai prosedur yang telah ditetapkan dan sesuai
dengan ketentuan CPOB dan cGMP terbaru dan harus selalu update karena obat
merupakan komoditi yang memerlukan perlakuan khusus dari mulai bahan baku
sampai pengemasan obat.
Pengawasan mutu (QC)
Bagian pengawasan mutu (QC)
bertanggung jawab penuh dalam seluruh tugas pengawasan mutu mulai dari bahan
awal, produk antara, produk ruahan, dan produk jadi.
Pemastian mutu (QA)
Bagian pemastian mutu (QA) bertugas
untuk memverifikasi seluruh pelaksanaan proses produksi, pemastian pemenuhan
persyaratan seluruh sarana penunjang produksi, dan pelulusan produk jadi. Dalam
hal ini, pemastian mutu adalah suatu konsep luas yang mencakup semua hal yang
akan mempengaruhi mutu dari obat yang dihasilkan, seperti personel, sanitasi
dan higiene, bangunan, sarana penunjang, dan lain-lain.
Penelitian dan pengembangan (Research &
Development/R&D)
Di bagian penelitian dan
pengembangan, baik untuk obat baru ataupun me too product, farmasis
atau apoteker berperan dalam menentukan formula, teknik pembuatan, dan
menentukan spesifikasi bahan baku yang digunakan, produk antara, dan produk
jadi. Pengembangan produk ini dilakukan mulai dari skala laboratorium, skala
pilot, hingga skala produksi. Di beberapa industri, bagian pengembangan produk
juga bertanggung jawab terhadap desain kemasan produk.farmatika
PPIC (Production Planning and Inventory Control)
Bagian ini bertugas merencanakan
produksi dan mengendalikan keseimbangan antara persediaan dengan permintaan
sehingga tidak terjadi overstock maupun understock.
Bagian PPIC ini biasanya juga bergabung dengan bagian gudang (gudang bahan
baku, bahan kemas, dan produk jadi) dan dikepalai oleh seorang apoteker.
Pembelian (Purchasing)
Bagian pembelian melayani pembelian
bahan baku dan bahan kemas yang dibutuhkan baik untuk proses produksi, proses
penelitian dan pengembangan produk, maupun untuk pengujian-pengujian yang
dilakukan QC. Kepala atau manager pembelian sebaiknya seorang apoteker karena
apotekerlah yang mengetahui tentang bahan baku dan bahan kemas itu sendiri
beserta dokumen-dokumen penyertanya sehingga perusahaan tidak salah memilih
atau tertipu oleh supplier (pemasok bahan baku atau bahan kemas).
Registrasi
Dalam registrasi obat ke Badan POM
diperlukan dokumen-dokumen yang harus disiapkan, seperti dokumen bahan aktif,
formula, proses pembuatan, data uji disolusi terbanding, data uji stabilitas,
BA/BE dan lain-lain. Data-data tersebut yang mengerti adalah seorang farmasis.
Promosi obat kepada tenaga profesional lain (medical
representative)
Apoteker dapat mempromosikan obat
kepada tenaga profesional lain seperti kepada dokter karena apotekerlah yang
paling mengerti tentang obat sehingga dapat menjelaskan keunggulan produk yang
ditawarkannya dari sisi ilmiah. Industri farmasi sekelas novartis dan Pfizer
mengharuskan seorang medical representatifnya minimal seorang sarjana farmasi
bukan sarjana diluar farmasi dan farmasis.
.
Mengapa posisi tersebut diatas diharuskan atau dianjurkan
seorang farmasi atau apoteker ? kenapa tidak sarjana lainnya ?
Karena obat adalah komoditi khusus
yang memerlukan perlakuan khusus mulai dari bahan baku sampai proses kemasannya
tidak sembarang keilmuan dapat menangani komoditi obat
Karena seorang apoteker dibekali keilmuan terkait
farmasi industri secara keseluruhan dari tingkat produksi sampai tingkat
manajemen farmasi industri, tidak hanya pada bidang keilmuan farmasi klinis.
pharmaceutical Industry
production
Production department in charge of running the production process according to established procedures and in accordance with the latest GMP and cGMP and should always be updated because the drug is a commodity that requires special treatment of the starting raw material to packaging drugs .
Quality control ( QC )
Part of the quality control ( QC ) take full responsibility in all quality control tasks ranging from starting materials , intermediate products , bulk products and finished products .
Quality assurance ( QA )
Part of quality assurance ( QA ) served to verify the implementation of the entire production process , ensuring compliance with all requirements of production support facilities , and the release of the finished product . In this case , quality assurance is a broad concept that includes all the things that will affect the quality of the resulting drugs , such as personnel , sanitation and hygiene , building , supporting , and others.
Research and development ( R & D / R & D )
In the research and development , both for new drugs or me too product , pharmacists or pharmacist role in determining the formula , making technique , and determine the specifications of the raw materials used , intermediate products , and finished products . Product development is done starting from the laboratory scale , pilot scale , to the scale of production . In some industries , product development section is also responsible for packaging design produk.farmatika
PPIC ( Production Planning and Inventory Control )
This section is in charge of production planning and control the balance between supply with demand so there is no overstock or understock . PPIC part is usually also joined the warehouse ( warehouse of raw materials , packaging materials , and finished products ) and headed by a pharmacist .
Purchasing ( Purchasing )
Serving the purchasing department purchases of raw materials and packaging materials required for the production process , the process of research and product development , as well as for the tests performed QC . Head or manager should purchase a pharmacist because apotekerlah who know about raw materials and packaging materials itself and its accompanying documents so the company is not one of choosing or deceived by suppliers ( suppliers of raw materials or packaging materials ) .
registration
In drug registration to the POM required documents that must be prepared , such as document active ingredients, formulas , manufacturing processes , compa dissolution test data , test data stability , BA / BE and others. These data are a pharmacist who understands .
Promotion of the drug to other professionals ( medical representative )
Pharmacists can promote the drug to other professionals such as a doctor because most apotekerlah understand about the drug so as to explain the benefits of products on offer from the scientific side . Pharmaceutical industry Novartis and Pfizer class requires a minimum of an undergraduate medical pharmaceutical reps not graduate beyond the pharmacy and pharmacist
.
Why the above positions are required or recommended a pharmacy or a pharmacist ? why not other scholars ?
Because medicine is a special commodity that requires special treatment ranging from raw materials to the packaging process is not just any commodity science can handle drugs
Due to a related science equipped Pharmacists pharmaceutical industry as a whole from the production level to management level pharmaceutical industry , not only in the scientific field of clinical pharmacy
production
Production department in charge of running the production process according to established procedures and in accordance with the latest GMP and cGMP and should always be updated because the drug is a commodity that requires special treatment of the starting raw material to packaging drugs .
Quality control ( QC )
Part of the quality control ( QC ) take full responsibility in all quality control tasks ranging from starting materials , intermediate products , bulk products and finished products .
Quality assurance ( QA )
Part of quality assurance ( QA ) served to verify the implementation of the entire production process , ensuring compliance with all requirements of production support facilities , and the release of the finished product . In this case , quality assurance is a broad concept that includes all the things that will affect the quality of the resulting drugs , such as personnel , sanitation and hygiene , building , supporting , and others.
Research and development ( R & D / R & D )
In the research and development , both for new drugs or me too product , pharmacists or pharmacist role in determining the formula , making technique , and determine the specifications of the raw materials used , intermediate products , and finished products . Product development is done starting from the laboratory scale , pilot scale , to the scale of production . In some industries , product development section is also responsible for packaging design produk.farmatika
PPIC ( Production Planning and Inventory Control )
This section is in charge of production planning and control the balance between supply with demand so there is no overstock or understock . PPIC part is usually also joined the warehouse ( warehouse of raw materials , packaging materials , and finished products ) and headed by a pharmacist .
Purchasing ( Purchasing )
Serving the purchasing department purchases of raw materials and packaging materials required for the production process , the process of research and product development , as well as for the tests performed QC . Head or manager should purchase a pharmacist because apotekerlah who know about raw materials and packaging materials itself and its accompanying documents so the company is not one of choosing or deceived by suppliers ( suppliers of raw materials or packaging materials ) .
registration
In drug registration to the POM required documents that must be prepared , such as document active ingredients, formulas , manufacturing processes , compa dissolution test data , test data stability , BA / BE and others. These data are a pharmacist who understands .
Promotion of the drug to other professionals ( medical representative )
Pharmacists can promote the drug to other professionals such as a doctor because most apotekerlah understand about the drug so as to explain the benefits of products on offer from the scientific side . Pharmaceutical industry Novartis and Pfizer class requires a minimum of an undergraduate medical pharmaceutical reps not graduate beyond the pharmacy and pharmacist
.
Why the above positions are required or recommended a pharmacy or a pharmacist ? why not other scholars ?
Because medicine is a special commodity that requires special treatment ranging from raw materials to the packaging process is not just any commodity science can handle drugs
Due to a related science equipped Pharmacists pharmaceutical industry as a whole from the production level to management level pharmaceutical industry , not only in the scientific field of clinical pharmacy
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