FOREIGN GMP INSPECTION GUIDANCE DOCUMENT, 8 TH EDITION (SEPTEMBER 2021)
MIS MPC • April 1, 2024
Muat Turun Dokumen
To provide information on the types of GMP evidence acceptable to the DCA of Malaysia. To provide the requirements for an on-site inspection of manufacturing facility outside Malaysia where GMP evidence of the premise is not available or acceptable to the DCA of Malaysia. To provide guidance on how to apply for an on-site foreign GMP inspection, the eligibility and application for GMP Desktop Assessment (GDA) for foreign manufacturers previously inspected by NPRA
Kementerian:
Kementerian Kesihatan Malaysia (KKM)
Agensi:
Agensi Regulatori Farmasi Negara (NPRA)
Lokasi:
JOHOR, KEDAH, KELANTAN, W.PERSEKUTUAN (KL), LABUAN, MELAKA, NEGERI SEMBILAN, PAHANG, PUTRAJAYA, PERLIS, PULAU PINANG, PERAK, SABAH, SELANGOR, SARAWAK, TERENGGANU
