WHO good manufacturing practices for sterile pharmaceutical products

1. General considerations
2. Quality control
- ly mu mang tnh i din v c nguy c cao
- cc sn phm nc pha tim hay dd tim truyn cn ch n ni c t
- phng php vi sinh nhanh cn kim nh
3. Sanitation
- cht ty ra: phi hp nhiu cht, m bo dit VK v khng li dm d
- cc gc cht: pp xng hi
4. Manufacture of sterile preparations: c 2 yu t chnh cn kim xot l tiu phn v vi
sinh vt
- tng ng vi cc g sx s c cc yu cu v mc sch thch hp
- yu cu v sch: KTTP, s lng VK, tc trao i kh,
- mng lc HEPA: cn test mng lc
- tn sut gim st, m s lng tiu phn trong khu A cn thc hin thng xuyn. Khu
B cng vy n t hn
- ch nht l sau khi c s gin on
- cc pp kim sot vi sinh l: t a, ly mu b mt v khng kh
- cc sn phm tit khun cui:
Pha ch bt thc hin trong khu D, nu d nhim th lm trong khu C
ng l phi thc hin trong khu C

 Nu d nhim th cn ng l trong khu A vs mi trng xung quanh thp nht l

khu C
-Pha ch v trng
Thnh phn sau khi ra phi x l khu D
nguyn kiu v trng ban u m bo mt khu A vi khu B xq
- quy trnh
Khng nn bo ch cc ch phm cha vi sinh vt sng trong khu vc s dng sx
cc sp khc tr th nh sx chng minh c rng k c nguy c

5. Sterilization

6. Terminal sterilization
7. Aseptic processing and sterilization by fi ltration
8. Isolator technology
9. Blow/fi ll/seal technology
10. Personnel
11. Premises
12. Equipment
13. Finishing of sterile products
2. quality control
2.1 test th vk phi tin hnh