Beruflich Dokumente
Kultur Dokumente
PERSONALIA
European Committee
for Standardization
Implementing Agency
1
Project co-financed by
European Union Project co- financed
by Asean
ISI PRESENTASI
Tujuan
Ruang Lingkup
Prinsip
Ketentuan Umum
Personil kunci (Key Personnel)
Pelatihan
Higiene Perorangan
Dokumentasi
Daftar Pustaka
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 2
Project co-financed by
European Union Project co- financed
by Asean
PENDAHULUAN
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 3
Project co-financed by
European Union Project co- financed
by Asean
PENDAHULUAN
Perusahaan dapat berinvestasi dan membeli fasilitas
serta peralatan. Bagaimanapun, Sumber daya yang
paling besar yang dimiliki perusahaan adalah
personalia.
TUJUAN
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 5
Project co-financed by
European Union Project co- financed
by Asean
RUANG LINGKUP
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 6
Project co-financed by
European Union Project co- financed
by Asean
PERSYARATAN UMUM
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 7
Project co-financed by
European Union Project co- financed
by Asean
PRINSIP
Penetapan dan pemeliharaan sistem Jaminan Mutu
yang memuaskan dan proses pembuatan kosmetik
yang ditentukan oleh kualitas personalia.
Jumlah personil yang dan mempunyai kualitas untuk
menyelesaikan tugasnya.
Tanggung jawab individu harus dipahami seara jelas
oleh individu yang terkait.
Semua personil harus sadar akan prinsip CPKB yang
memberikan dampak kepada mereka dan pelatihan
berkelanjutan termasuk instruksi higiene yang
berhubungan dengan kebutuhan mereka.
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 8
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 9
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 10
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 11
Project co-financed by
European Union Project co- financed
by Asean
PERSONIL POKOK
Personil pokok (biasanya bekerja secara penuh)
meliputi posisi:
Kepala Produksi
Kepala Pengendalian Mutu
Kepala Produksi dan Kepala Pengendalian Mutu harus
tidak terkait (independen) satu dengan lainnya
Untuk organisasi yang besar mungkin perlu
pendelegasian beberapa fungsi; tapi bagaimanapun,
tanggung jawabnya tidak bisa didelegasikan.
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 12
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 13
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 14
Project co-financed by
European Union KEPALA BAGIAN Project co- financed
by Asean
PENGENDALIAN MUTU
Memberi Pelulusan atau penolakan bahan baku, bahan
pengemas, produk antara, produk ruahan dan produk jadi
Mengevaluasi Catatan Batch.
Melakukan pengujian yang diperlukan
Memberi persetujuan terhadap prosedur pengendalian mutu
seperti instruksi pengambilan contoh, spesifikasi, metoda uji dan
prosedur PM yang lain
Memberi persetujuan dan pemantauan terhadap semua kontrak
pengujian mutu.
Memelihara laboratorium PM, termasuk peralatan dan piranti
laboratorium lainnya.
Kalibrasi peralatan pengawasan mutu
Mengadakan pelatihan dasar dan lanjutan bagi petugas PM.
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 15
Project co-financed by
European Union Project co- financed
by Asean
1.0 Purpose
To outline the basic responsibilities of key personnel of the plant.
2.0 Scope
This SOP applies to all key personnel in the plant addressed below.
3.0 Responsibility
It is the responsibility of the Plant Manager to define the responsibilities of the key personnel, to ensure that this SOP is updated accordingly
with changes in their responsibilities, and to clearly relay these responsibilities and job duties to these personnel. It is the responsibility of
the key personnel addressed in this SOP to adhere to and perform their functions and report to the Plant Manager as necessary.
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 17
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 20
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 21
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 22
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 23
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 24
Project co-financed by
European Union Project co- financed
by Asean
DAFTAR PUSTAKA
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 25
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Module 2
Implementing Agency GMP Workshop Jakarta 4 5 April 2006 26