TERJEMAHAN PIC/S BAGIAN ANEKS 2018 (PE 009-14)

GMP Platform akan menterjemahkan PIC/S Bagian Aneks 2018 (PE 009-14) yang terbit 1 Juli 2018 lalu. Anda dapat melihat dan membaca terjemahan keseluruhannya melalui tautan yang ada di dalam tabel di bawah ini. Tabel ini akan diperbarui secara berkala:   ANEKS 1 – PEMBUATAN PRODUK STERIL NO SUB…

CPOB 2012 vs CPOB 2018 (Bab 2 – Personalia)

Perbandingan antara Bab 2 CPOB 2012 dengan CPOB 2018 Jika Bab 2 CPOB 2018 dibandingkan dengan Bab 2 pada CPOB 2012, tidak terdapat banyak perubahan jika dilihat dari banyaknya klausul, maupun isinya. Bertambahnya klausul di dalam Bab 2 CPOB 2018 merupakan akibat dari penghilangan…

PIC/S BAB II (PERSONALIA) – KONSULTAN

BAB II (PERSONALIA) – KONSULTAN NO VERSI ASLI VERSI TERJEMAHAN 2.21 Consultants should have adequate education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Konsultan harus memiliki pendidikan, pelatihan, dan pengalaman yang memadai,…

PIC/S BAB II (PERSONALIA) – HIGIENE PERORANGAN

BAB II (PERSONALIA) – HIGIENE PERORANGAN NO VERSI ASLI VERSI TERJEMAHAN 2.15 Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These…

PIC/S BAB II (PERSONALIA) – PELATIHAN

BAB II (PERSONALIA) – PELATIHAN NO VERSI ASLI VERSI TERJEMAHAN 2.10 The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for…

PIC/S BAB II (PERSONALIA) – PERSONIL KUNCI

BAB II (PERSONALIA) – PERSONIL KUNCI NO VERSI ASLI VERSI TERJEMAHAN 2.5 Senior Management should appoint Key Management Personnel including the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the…

PIC/S BAB II (PERSONALIA) – PRINSIP UMUM

BAB II (PERSONALIA) – PRINSIP NO VERSI ASLI VERSI TERJEMAHAN The correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual…