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) Kræv, at farmaceutiske industrier ikke kun beviser lægemidlers effektivitet, men også beviser lægemidlers sikkerhed.
(2) Require pharmaceutical industries to report drugs' adverse reaction to FDA
(3) Kræve, at farmaceutiske industrier implementerer lægemiddelproduktion og kvalitetsstyringspraksis
I 1963 proklamerede USA's kongres den første GMP i verden.
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. Hvad er den centrale vejledende tanke for GMP?
A: Den centrale vejledende tanke for GMP-implementering er: dannelsen af enhver lægemiddelkvalitet er designet, ikke testet. For at udføre denne centrale vejledning skal vi:
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. Hvad er forskellene mellem GMP og TQC?
A: TQC er fuldstændig kvalitetskontrol, GMP er en materialisering i medicinproduktion. TQC bestemmes af data, nøglen er overordnet, GMP kræver, at alt er dokumenteret, nøglen er streng. Derfor er TQC guiden til GMP, GMP er den implementerede løsning.
4. What's the differences between QA and QC?
A: QA er forkortelsen for kvalitetssikring, dets hovedarbejde er dokumentformulering, undersøgelse, overvågning og færdigvaregennemgang og -udstedelse. QC er forkortelsen for kvalitetskontrol, som bruger mikrobiologi, fysik og kemisk identifikation og andre aspekter til at kontrollere kvaliteten.
5. Hvad er hovedindholdet af GMP?
A: Det kan opsummeres som wetware, hardware, software. Wetware er personale, hardware er anlæg, facilitet og udstyr, software er organisation, system, teknologi, drift, hygiejnisk standard, registrering, uddannelse og andre ledelsesbestemmelser.
(1) Personale: har brug for et antal fagfolk, alle medarbejdere skal deltage i faglig videnstræning og GMP-videntræning.
(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. Hvor mange kapitler består GMP, og hvornår skal det implementeres?
A: GMP har 14 kapitler og 88 artikler i alt og har været implementeret siden 1. august 1999. Den seneste version er version 2010.
7. Hvilke betingelser skal være opfyldt for at starte en lægemiddelproduktionsvirksomhed
A: Start af en farmaceutisk produktionsvirksomhed skal have følgende betingelser:
(1) At have juridisk kvalificerede apoteksteknikere, ingeniørteknikere og relevant faglært arbejder
(2) Have anlæg, faciliteter og hygiejniske omgivelser, der er egnede til dets farmaceutiske produktion
(3) Have institution, personale og nødvendigt instrument og udstyr, der kan udføre kvalitetsstyring og kvalitetsinspektion for produktionsmedicin
(4) At have regler og forskrifter for at sikre kvaliteten af lægemidler
8. Hvorfor sige, at GMP-dokumenter er lærebogen for personaleuddannelse?
A: Implementering af GMP skal kombineres med virksomhedernes faktiske situation, det omfatter organisation, personalesammensætning og kvalitet, produktion og mange andre faktorer. For det almindelige personale er det vigtigere, at de gennem grundlæggende GMP-videntræning ved, hvordan de skal følge reglerne i den daglige arbejdsproces, med andre ord, de skal helt beherske grundlæggende arbejdsfærdigheder og GMP-krav.
9. Hvorfor skal GMP-dokumenter angive godkendelsesdatoen og udførelsesdatoen?
A: Det er umuligt at starte udførelsen på dagen for GMP-dokumentets godkendelse. Det skal opfylde procedurerne for udstedelse af dokumenter. Denne proces tager en vis tid, og samtidig skal et nyt godkendt dokument også have en uddannelse. Så der er et hul mellem godkendelsestid og eksekveringstid.
10. Hvad skal man være opmærksom på, når GMP-dokumenter udstedes og genanvendes?
A: (1) Det udstedte dokument skal registreres og underskrives af modtageren. (2) Forældede dokumenter skal inddrives den dag, hvor det nye dokument fuldbyrdes, og optegnelser skal opbevares; (3) Forældede dokumenter destrueres eller arkiveres af dokumenthåndteringsafdelingen.
11. Hvad er de tre målkomponenter i GMP?
A: (1) Hold menneskelige fejl på et minimum;(2)Undgå forurening af stoffer;(3)opbyg et strengt kvalitetssikringssystem, garanterer produkternes kvalitet.
12. Hvad er SMP, og hvilket indhold indeholder det?
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. Hvad er SOP, og hvilket indhold indeholder det?
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. Hvad er SOR, og hvilket indhold indeholder det?
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. Hvordan udfører man GMP-selv-inspektion?
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. Hvordan klassificeres de nuværende GMP-dokumenter?
A: Aktuelle GMP-dokumenter er opdelt i to kategorier, standarddokumenter og journal-, voucher- og rapportdokumenter. I kategorien standarddokumenter inkluderer den (1) tekniske standarddokumenter; (2)styringsstandarddokumenter; (3)arbejdsstandarddokumenter.