1. What's the origin of GMP and what's the Chinese meaning?
A: The appearance of GMP was related to the world-shacking thalidomide drug accident. Thalidomide is a kind of sedatives. In the late 1950s, Former Federal Germany Glennan Su Pharmaceutical Factory produced this drug to treat pregnant woman vomiting during pregnancy. In the six years after the sale, more than 12,000 malformed fetuses and 1,300 cases of polyneuritis were caused in 28 countries including the Federal Germany and Japan. America didn't allow to import thalidomide at that time and was basically not affected. However, the serious consequence of this accident caused nervous feeling in America, America public took more concerns about drug supervision and drug regulations, which resulted a great alteration on Food, Drug and Cosmetic Law. The 1962 amendment significantly strengthened the enforcement of the Pharmaceutical Law in the following three aspects:
(1) Mande endistri pharmaceutique non sèlman pou pwouve efikasite dwòg yo, men tou pou pwouve sekirite dwòg yo.
(2) Require pharmaceutical industries to report drugs' adverse reaction to FDA
(3) Egzije endistri pharmaceutique pou aplike pwodiksyon dwòg ak pratik jesyon kalite
An 1963, Kongrè Etazini te pwoklame premye GMP nan mond lan.
GMP is the abbreviation of Good Manufacturing Practice. Because manufacture contains tow means, production and quality management. And GMP have already become the basic standards of drugs' production and quality management in the international world, is a systematic and scientific management system. So ...
2. Ki sa ki gid santral panse GMP?
A: Gid santral te panse de GMP mete ann aplikasyon se: fòmasyon nenpòt kalite dwòg fèt, pa teste. Pou pote gid santral sa a, nou dwe:
⑴ Relatively fixed suppliers of main raw materials and packaging materials, insist on quality evaluation of suppliers
⑵ The plant area is planned according to the principles of function and pollution prevention
⑶ The plant production requires reasonable layout to avoid pollution and cross-contamination, and meet the specified cleanliness requirement.
⑷ Pharmaceutical equipment is reasonable allocation, using advanced equipment and intelligent equipment, eliminating the equipment which easy to cause pollution and cross-contamination in production.
⑸ All work is documented. Making documents really become the lows of company, against plagiarizing, copy, implementation of documents as a mere formality, or see documents as decoration.
⑹ Standardize various operations
⑺ Strict quality management requirement. Carrying out three-level quality management system, completing quality evaluation system, supervision system and reporting system. Continuously improving the level of drug standards.
⑻ Scientific Verification
⑼ Systematic personnel training
⑽ Regular does health work
⑾ Completing after sales service,timely report major quality accidents and adverse reactions of drugs, let drugs quality under a rigorous supervision control, nip in the bud.
3. Ki diferans ki genyen ant GMP ak TQC?
A: TQC se totalman kontwòl kalite, GMP se yon materyalizasyon nan pwodiksyon medikaman. TQC deside pa done, kle a an jeneral, GMP mande pou tout bagay yo dwe dokimante, kle a se solid. Se poutèt sa, TQC se gid panse a GMP, GMP se solisyon an aplike.
4. What's the differences between QA and QC?
A: QA se abrevyasyon pou asirans kalite, travay prensipal li se fòmilasyon dokiman, ankèt, sipèvizyon ak revizyon ak emisyon pwodwi fini. QC se Abreviyasyon pou kontwòl kalite, ki itilize mikrobyoloji, fizik ak idantifikasyon chimik ak lòt aspè pou kontwole bon jan kalite a.
5. Ki sa ki prensipal nan GMP?
A: Li ka rezime kòm wetware, pyès ki nan konpitè, lojisyèl. Wetware se pèsonèl, pyès ki nan konpitè se plant, etablisman ak ekipman, lojisyèl se òganizasyon, sistèm, teknoloji, operasyon, estanda ijyenik, anrejistreman, edikasyon ak lòt règleman jesyon.
(1) Pèsonèl: bezwen yon kantite pwofesyonèl, tout anplwaye yo bezwen ale nan fòmasyon konesans pwofesyonèl ak fòmasyon konesans GMP.
(2) Plant facility need to meet GMP cleanliness level requirements, drug must be produced in a clean area, used production equipment requires a combination of advancement and applicability, equipment need to be easy to clean and can't react with any drug.(Generally made by stainless steel)
6. Konbyen chapit GMP konpoze ak ki lè l ap aplike?
A: GMP gen 14 chapit ak 88 atik nan total, e li te aplike depi 1ye Out 1999. Dènye vèsyon an se vèsyon 2010.
7. Ki kondisyon yo ta dwe satisfè pou kòmanse yon antrepriz pwodiksyon pharmaceutique
A: Kòmanse yon antrepriz pwodiksyon pharmaceutique dwe gen kondisyon sa yo:
(1) Gen teknisyen famasi legalman kalifye, teknisyen jeni ak travayè kalifye ki enpòtan.
(2) Gen plant, enstalasyon ak anviwònman ijyenik apwopriye pou pwodiksyon pharmaceutique li yo
(3) Gen enstitisyon, pèsonèl, ak enstriman ak ekipman ki nesesè ki ka fè jesyon kalite ak enspeksyon kalite pou pwodiksyon dwòg.
(4) Gen règ ak règleman pou asire bon jan kalite medikaman yo
8. Poukisa di dokiman GMP se liv fòmasyon anplwaye yo?
A: Aplike GMP dwe konbine avèk sitiyasyon aktyèl la nan konpayi yo, li gen ladan òganizasyon, konpozisyon anplwaye ak bon jan kalite, pwodiksyon ak anpil lòt faktè. Pou anplwaye jeneral, bagay ki pi enpòtan se ke atravè fòmasyon konesans debaz GMP, yo pral konnen ki jan yo swiv règleman yo nan pwosesis travay la chak jou, nan lòt mo, yo bezwen konplètman metrize ladrès debaz travay ak kondisyon GMP.
9. Poukisa dokiman GMP bezwen presize dat apwobasyon ak dat ekzekisyon?
A: Li enposib kòmanse egzekisyon nan jou a nan apwobasyon dokiman GMP. Li bezwen ranpli pwosedi emisyon dokiman yo. Pwosesis sa a pran yon sèten kantite tan, ak an menm tan, nouvo dokiman apwouve tou bezwen yon fòmasyon. Se konsa, gen yon diferans ant tan apwobasyon ak tan ekzekisyon.
10. Ki sa ki ta dwe konnen lè dokiman GMP bay ak resikle?
A: (1) Dokiman yo bay yo dwe anrejistre, epi siyen pa moun k ap resevwa a. (2)Dokiman demode yo dwe refè nan jou nouvo dokiman an egzekite, epi yo dwe kenbe dosye yo; (3) Depatman jesyon dokiman an detwi oswa achive dokiman demode yo.
11. Ki sa ki twa konpozan sib nan GMP?
A: (1) Kenbe erè imen nan yon minimòm; (2) Evite polisyon pou dwòg; (3) bati yon sistèm asirans kalite solid, garanti bon jan kalite a nan pwodwi yo.
12. Ki sa ki SMP, ak ki sa ki ladan l?
A: SMP is the abbreviation for Standard Management Procedure. Its Chinese meaning is 标准管理程序. SMP includes: 1,document management; 2,materials management; 3,production management; 4,quality management; 5,equipment and measurement management; 6,verification management; 7,administrative management; 8,hygiene management; 9,personnel training management; 10,plant and facility management.
13. Ki sa ki SOP, ak ki sa ki ladan l?
A: SOP is the abbreviation for Standard Operation Procedure. Its Chinese meaning is 标准操作程序. SOP includes: 1,production operating procedures; 2,quality control procedures; 3,equipment and measurement operating procedures; 4,materials processing procedures; 5,cleaning procedures; 6,hygienic operating procedures.
14. Ki sa ki SOR, ak ki sa ki ladan l?
A: SOR is abbreviation for Standard Operation Records, it's Chinese meaning is records, voucher files. SOR includes (1)Material management records; (2) Production operating records; (3) Quality inspection and management records; (4) Equipment operation and management records; (5) hygienic operation and management records; (6) sales records; (7) Verification report and verification record; (8) Personnel training and assessment records; (9) Document issuance and recycling records.
15. Ki jan yo fè GMP pwòp tèt ou-enspeksyon?
A: In order to assure the validity of corporation quality assurance system,the whole process of drug production is consistently controlled. In the implementation process of GMP, after a period, organize special personnel to conduct a comprehensive self-inspection of the company's GMP implementation, or conduct a targeted self-inspection for company's major quality issues, and list rectification measures and deadline. List the problems and make rectifications, then conduct random checks or follow-ups, and record the results. In the next period of self-inspection, fist check whether the problems last found have been rectified or not, and what are the problems in the rectification, and at the same time list the problems found this time as the content of the rectification. Self-inspection result and rectified solutions of each time all need a detail record.
16. Ki jan yo klase dokiman GMP aktyèl yo?
A: Aktyèl dokiman GMP yo divize an de kategori, dokiman estanda ak dosye, bon ak dokiman rapò. Nan kategori dokiman estanda, li gen ladan (1) dokiman estanda teknik; (2) dokiman estanda jesyon; (3) travay dokiman estanda.