K H A O S A T V E H I E U B I E T V A N H U C A U A P D U N G HE THONG QUAN LY CHAT LUONG THEO GIVIP
TRONG SAN XUAT THUC PHAM CHUfC NANG NGUYfeN XUAN HOANG
Hiep hoi TPCN Viet nam
Tom tat:
Be tai da phong van cac can bp quan ly, cong ty san xuat dupe va thpc pham chdc nang cac co sd y hoc cd truyen cd san xua't thpc pham chifc nang, cac hieu thudc va cac cong ty ban hang da cap. Tong so 50 mau phieu cho tha'y: cd 60% khong quan tam den GMP thpc pham chifc nang va 40% co quan tam den van de nay (chu yeu la cac nha quan ly)
Thpc hien GMP trong san xua't thpc pham chut nang la rat quan trong de cac nha san xuat kiem soat tdt quy trinh san xua't dac biet la van de ve sinh an toan thpc pham dupe bao dam.
Be nghi nha nuPc sPm ban hanh tieu chuan GMP cho TPCN de cac cO sd san xua't cac san pham TPCN dam bao chat lupng va an toan ve sinh thpc pham.
THE SURVEY OF K N O W L E D G E A N D NEEDS OF APPLYING THE QUALITY M A N A G E M E N T SYSTEM OF FUNCTIONAL FOOD WITH GMP
Abstract:
This survey has conducted by interviewing the managerial staff, pharmacies companies and functional food premises, traditional medicine units produced functional food, pharmacy stores and multi-trading companies. With 50 forms interviewed, the result showed that: 60% of whom answered that they didn't care for functional food production applied with GMP and 40% of whom cared for this issue (almost was managerial staff).
Applying functional food production with GMP is very necessary sothat producers could control the production stage well, especially assuring food safety and hygiene.
It is suggested that GMP standards for functional food should be issued soon, supporting the functional food producers to assure the quality and safety of food.
I . D A T V A N D E
San pham thuc p h i m chuc nang (TPCN) mudn dupe luu hanh phai dam bao tieu chuin chat lupng, an toan va hieu qua. Mudn the, viec ap dung GMP trong san xua't TPCN la c i n thiet va b i t buoc. Mudn d i m bao dupe chat lupng san p h i m TPCN c i n phai: (1) A p dung GMP; (2) Cd chuong trinh quan ly chit lupng va (3) kiem tra chit lupng.
Song d nuoc ta chua co tieu chuan GMP cho san xuat TPCN nen hon 500 doanh nghiep san xua't thuc p h i m hien tai voi tren 1500 san p h i m TPCN chua biet den GMP va ap dung GMP. Cac cong ty san xua't dupe trien khai ap dung GMP, nhung hon 10 nam, den nay moi chi co 70 nha may dupe pham dupe cap chung nhan GMP, con gan 100 nha may chua dupe cap chung nhan GMP. Cac nha may san xua't dupe gan day cung da chuye'n sang san x u i t TPCN.
Viec trien khai ap dung GMP cho cac co sd san xua't TPCN la can thiet. De chuin bi cho viec ap dung GMP c i n thiet cd mpt khao sat ve thuc trang va nhu c i u ap dung GMP cua cac co sd sin x u i t TPCN.
Muc dich nghien cdu
1. Danh gia thuc trang nhan thuc ve t i m quan trong cua GMP ddi vdi co sd san x u i t TPCN.
2. Danh gia thuc trang nhan thdc ve ap dung cac nguyen t i c cua G M P d co sd san xua't TPCN.
II. DOI TlTONG VA PHUONG PHAP NGHIEN CUU 2.1. Ddi tupng nghien cuu
Cac van b i n hudng d i n thuc hanh san xua't tdt TPCN cua To chuc Y te The gidi (WHO), ciia EU va ciia khu vuc ASEAN (Ban drap), va van b i n hudng d i n ve GMP cua W H O ve sin xuit dupe phim, thuo'c y hpc cd truyen. Mpt sd cong ty, co sd, cac diem kinh doanh ve thudc va thuc phim chdc nang, cong ty da cip.
Qua thuc tidn ciia san xua't TPCN Viet Nam (vd con ngudi, didu kien co so vat chit, trang thiet bi, vd mong mudn san p h i m cd chit lupng cao...) de dd x u i t ap dung GMP theo thuc te tai Viet Nam.
2.2. Phuong phap nghien cdu
2.2.1. Phong van theo bdng cdu hdi cdc can bd quan ly, lao ddng, cdc ca sd san xuat TPCN
- Phong vin 50 nguoi la giam ddc, chii co sd va phu trach hieu thuo'c.
- Cac co so kinh doanh thuc phim chdc nang: Cong ty dupe p h i m , cong ty chuyen san xuit TPCN, co so y hpc cd truydn, cong ty phan phdi TPCN, cong ty ban hang da cip, hieu thuo'c.
2.2.2. Phuong phap phdn tich tdi lieu
- Phan tich danh gia cac tai lieu lien quan tdi hudng din thuc hanh sin xuat dupe
phim, thudc y hpc cd truydn, TPCN, thuc phim ciia the gidi, khu vuc va Viet Nam.
- Tim ra cac diem trong yeu de khuyen cao ap dung cho thuc tidn sin x u i t TPCN d Viet Nam.
I I I . K E T QUA V A B A N L U A N
3.1. Ket qua phong van nhan thirc ve tam quan t r o n g cua G M P Bdng J. Cdc co so san xua't vd hieu biet ve GMP TPCN
T T Loai don v j Sd
m i u (N)
Khong quan tam G M P T P C N
Cd quan tam G M P T P C N T T k i n h doanh
Sd m i u
(N) Sd mau (n)
T y le ( % )
Sd mau (n)
Tv le ( % )
1 Cong ty SX duoc & TPCN 11 4 8 7 14
2 Cong ty chuyen SX TPCN 7 5 10 2 4
3 Co sd SX Y H C T Q 8 16 1
cd SX TPCN y 8 16 1 L
4 Cong ty chuyen kinh doanh
TPCN 5 1 20 4 8
5 Hieu thudc 15 12 24 3 6
6 Cong ty da cap 3 0 3 6
Tong sd 50 30 60 20 40
Qua phong van cac can bp quan ly chung toi thiy cd tdi 60% sd ngudi dupe hdi khong quan tam tdi GMP. Dieu dang ndi la la nhom it quan tam nhat la cac co so san xuit y hpc co truyen (cic co sd nay dang san x u i t TPCN). Va dii chi cd didu kien phong v i n 3 cong ty b i n hang da cap nhung hp coi GMP la b i t bupc, la khang dinh thuong hieu san phim. Cac cong ty dupe p h i m cung quan tam tdi GMP TPCN chi cd dieu hp khong biet tim tai lieu d dau.
- Ket qua phong v i n cho thay su khong quan tam toi GMP ve TPCN la rat dang ngai, va t i t ca deu chua dupe tiep can vdi tai lieu hudng d i n GMP ve TPCN.
- Trong qua trinh phong v i n , sd can bp quan ly co quan tam tdi GMP deu hieu dupe tam quan trong cua GMP va coi day la hudng d i u tu trong tuong lai, va hp cung coi do la xu the cua qua trinh hpi nhap vdi the gidi.
3.2. Ket qua phong van 20 can bp quan ly chat lupng thupc cong ty san xuit chuyen TPCN va cong ty dupe p h i m co sin xuat TPCN (khong phong van cong ty san xuit y hpc cd truydn) vd cac nguyen t i c trong GMP TPCN
Chiing toi cd ket qua sau:
Bang 2: Ket qud phong van ve su can thiet dp dung cdc nguyen tdc GMP
STT Cac nguyen tac t r o n g G M P Bat budc thuc hien
Khuyen cao thuc hien
K h d n g can thuc
hien
\~ He thdng quan ly chit lupng 20 0 0
2 Nhan su 17 3 0
3 Nha xudng & thiet bi 20 0 0
4 Ve sinh 20 0 0
5 Ho so tai lieu 20 0 0
6 Qua trinh san xuat 20 0 0
7 Kiem tra chat luong 15 5 0
8 San xuat va kiem nghiem 9 4 7
theo hop dong
9 Khieu nai va thu hoi san p h i m 11 9 0
10 T u thanh tra 6 13 1
Sau khi phan tich cac tai lieu ve GMP, HACCP chiing toi thay co 10 nguyen tac chinh trong qua trinh thuc hanh san xuat TPCN de dam bao chat luong san pham nhu bang 2. Yeu to he thdng cac tai lieu lien quan tdi nguon nguyen lieu hien dang dupe cac can bp quan ly chat lupng het sue coi trong, su can thiet phai lap du lieu an toan (Safety Data Sheet) cho nguyen lieu la uu tien hang dau. Nhung thuc te viec nay rat khd boi nguon nguyen lieu (nhat la tu thuc vat) khong 6n dinh, khong dat chuan (vi du cay dupe trdng theo tieu chuan GAP thi mdi kiem soat tdt dupe).
Qua bang tren chiing toi tha'y cac ca nhan dupe hoi rat quan tam tPi su can thiet phai thuc hien GMP cho san xua't thuc phim chdc nang . Day la dieu dang mirng vi cac cong ty san xua't nhan tha'y su can thiet de nang cao thuong hieu vdi ngudi tieu dung, hda nhap vdi the gidi.
Rieng phin "San xua't va kiem nghiem theo hpp ddng" so ngudi cho ring khPng
can thuc hien la 7/ 20, khuyen cao thuc hien la 4/20 cung chdng td tam ly cua cac nha quan ly san xua't mudn lam td A tdi Z khong mudn gia cong theo cong doan. Viec toan cau hda di doi vdi san xua't theo cong doan (out short) va se tiet kiem chi phi khong can thiet (chang han van chuyen, cong nghe, nhan luc...).
Vai trd cua GMP trong san xua't TPCN la rat quan trong no khong nhung chi dem lai hieu qua vd chat lupng cho nha san xua't, viec kiem soat quy trinh dac biet la van dd ve sinh an toan thuc pham dupe dam bao, ma van dd thanh tra, hau kiem cua cac co quan quan ly cung dd dang hon.
IV. KET KUAN VA KIEN NGHI 4.1. Ket luan
1. Sd nguoi dupe phong van hien it quan tam tdi van dd san xua't TPCN theo GMP, dd lai chu yeu la nhung ngudi lam cong tac kinh doanh cac san pham nay.
2. Nhung can bp phu trach quan ly chat lupng lai dac biet cd quan tam tdi GMP va da ddng y toi 9 tren 10 chi tieu bit bupc phai ap dung trong san xua't GMP.
4.2. Kien nghi
1. Cin ban hanh tieu chuan GMP cho cac co sd san xuit TPCN va hudng din thuc hien, c i n cd co che khuyen khich cac co so thuc hien GMP.
2. Thudng xuyen td chuc cac hpi thao khoa hpc ve GMP va cac tieu chuin khac
(GSP, GDP, GLP) trong nganh TPCN va phai cd IP trinh yeu c i u thuc hien v i n dd tren (nhu ddi vdi dupe phim) n h l m tao ra cho xa hpi cac san p h i m tdt.
3. Tang cudng giao due, tuyen truydn vd GMP de cac co sd san xua't TPCN hieu rp vai trd, t i m quan trong va ap dung.
T A I L I E U T H A M K H A O
1. Thuc hanh tdt san xuat GMP cho y hoc co truyen, XB ldn 2; 2003.
2. Hudng dan ciia EU ve GMP cho san phdm y hoc diing cho con ngudi vd ngudi dn kieng, Chuong 4, du thao phu luc 7; san xua't san phdm y hoc tii thao dupe.
3. Hudng dan thuc hanh tdt san xua't thudc, He thdng thanh tra dupe phdm (PIC/S) ngay 01/06/2006, Bp Y te.
4. WHO GMP, NXB Y hpc. Ha Npi 2005.
5. He thdng phdi hpp kiem tra dupe phdm, hudng ddn GMP cho san phdm y hoc, PE 009-5; 01/08/2009.
6. Chuong trinh kiem sodt GMP, GHP vd he thdng quan ly chat lupng ve sinh an toan thuc phdm HACCP, NXB Y hpc, Hd Npi 2004.
7. Thuc phdm chifc ndng, PGS, TS Tran Ddng, Hd Npi 2009.
