PIC/S BAB I (SISTEM MUTU FARMASI) – CARA PEMBUATAN OBAT YANG BAIK

BAB I (SISTEM MUTU FARMASI) – CARA PEMBUATAN OBAT YANG BAIK

NO VERSI ASLI VERSI TERJEMAHAN 1.8 Good Manufacturing Practice is that part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation, Clinical Trial Authorisation or product specification. Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that: Cara Pembuatan yang Baik merupakan bagian dari Manajemen Mutu yang memastikan bahwa produk dbuat secara konsisten dan terkendali sesuai standar mutu berdasarkan tujuan penggunaannya dan sesuai dengan Izin Edar, Izin Uji Coba Klinis atau spesifikasi produk. Cara Pembuatan yang Baik mempertimbangkan cara produksi dan pengawasan mutu. Persyaratan dasar CPB adalah:

INTERPRETASI:

Dasar dari CPB adalah menjamin mutu produk dengan menginspeksi hasil dari manajemen prosedur dan manajemen mutu

NO VERSI ASLI VERSI TERJEMAHAN 1.8

(i) All manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifications;

(ii) Critical steps of manufacturing processes and significant changes to the process are validated;

(iii) All necessary facilities for GMP are provided including:

Appropriately qualified and trained personnel; Adequate premises and space; Suitable equipment and services; Correct materials, containers and labels; Approved procedures and instructions, in accordance with the Pharmaceutical Quality System; Suitable storage and transport.

(iv) Instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided;

(v) Procedures are carried out correctly and operators are trained to do so;…