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) Ei gwneud yn ofynnol i ddiwydiannau fferyllol nid yn unig brofi effeithiolrwydd cyffuriau, ond hefyd i brofi diogelwch cyffuriau.
(2) Require pharmaceutical industries to report drugs' adverse reaction to FDA
(3) Ei gwneud yn ofynnol i ddiwydiannau fferyllol weithredu arferion cynhyrchu cyffuriau a rheoli ansawdd
Ym 1963, cyhoeddodd cyngres yr Unol Daleithiau y GMP cyntaf yn y byd.
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. Beth yw'r canllaw canolog a feddylir am GMP?
A: y canllaw canolog a feddylir wrth weithredu GMP yw: mae ffurfio unrhyw ansawdd cyffuriau wedi'i ddylunio, heb ei brofi. Er mwyn cyflawni’r canllawiau canolog hyn, rhaid inni:
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. Beth yw'r gwahaniaethau rhwng GMP a TQC?
A: Mae TQC yn rheoli ansawdd yn llwyr, mae GMP yn ddeunyddiad mewn cynhyrchu meddyginiaeth. Mae TQC yn cael ei benderfynu gan ddata, yr allwedd yn gyffredinol, mae GMP yn ei gwneud yn ofynnol i bopeth gael ei ddogfennu, mae'r allwedd yn drylwyr. Felly, TQC yw'r canllaw meddwl o GMP, GMP yw'r ateb a weithredir.
4. What's the differences between QA and QC?
A: QA yw'r talfyriad ar gyfer sicrhau ansawdd, ei brif waith yw llunio dogfennau, ymchwilio, goruchwylio ac adolygu a chyhoeddi cynnyrch gorffenedig. QC yw'r talfyriad ar gyfer rheoli ansawdd, sy'n defnyddio microbioleg, ffiseg ac adnabod cemegol ac agweddau eraill i reoli ansawdd.
5. Beth yw prif gynnwys GMP?
A: Gellir ei grynhoi fel llestri gwlyb, caledwedd, meddalwedd. Mae Wetware yn bersonél, caledwedd yw offer, cyfleuster ac offer, meddalwedd yw trefniadaeth, system, technoleg, gweithrediad, safon hylan, cofnodi, addysg a rheoliadau rheoli eraill.
(1) Personél: angen nifer o weithwyr proffesiynol, mae angen i bob aelod o staff fynychu hyfforddiant gwybodaeth broffesiynol a hyfforddiant gwybodaeth 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. Sawl pennod y mae GMP yn eu cynnwys a phryd y caiff ei roi ar waith?
A: Mae gan GMP 14 pennod ac 88 erthygl i gyd, ac fe'i gweithredwyd ers 1 Awst, 1999. Y fersiwn ddiweddaraf yw fersiwn 2010.
7. Pa amodau y dylid eu bodloni ar gyfer cychwyn menter cynhyrchu fferyllol
A: Rhaid i gychwyn menter cynhyrchu fferyllol fod â'r amodau canlynol:
(1) Bod â thechnegwyr fferyllol cymwys, technegwyr peirianneg a gweithiwr medrus perthnasol
(2) Cael planhigion, cyfleusterau ac amgylchedd hylan sy'n addas ar gyfer ei gynhyrchu fferyllol
(3) Cael sefydliad, personél, ac offeryn ac offer angenrheidiol a all wneud rheolaeth ansawdd ac arolygu ansawdd ar gyfer cyffuriau cynhyrchu
(4) Bod â rheolau a rheoliadau i sicrhau ansawdd meddyginiaethau
8. Pam dweud mai dogfennau GMP yw'r gwerslyfr hyfforddi staff?
A: Rhaid cyfuno gweithredu GMP â sefyllfa wirioneddol cwmnïau, mae'n cynnwys trefniadaeth, cyfansoddiad staff ac ansawdd, cynhyrchu a llawer o ffactorau eraill. Ar gyfer staff cyffredinol, peth pwysicach yw, trwy hyfforddiant gwybodaeth GMP sylfaenol, y byddant yn gwybod sut i ddilyn y rheolau yn y broses waith ddyddiol, mewn geiriau eraill, mae angen iddynt feistroli sgiliau gwaith sylfaenol a gofynion GMP yn llwyr.
9. Pam mae angen i ddogfennau GMP nodi'r dyddiad cymeradwyo a'r dyddiad gweithredu?
A: Mae'n amhosibl dechrau gweithredu ar ddiwrnod cymeradwyo dogfen GMP. Mae angen iddo gyflawni gweithdrefnau cyhoeddi dogfennau. Mae'r broses hon yn cymryd peth amser, ac ar yr un pryd, mae angen hyfforddiant hefyd ar ddogfen gymeradwy newydd. Felly mae bwlch rhwng amser cymeradwyo ac amser gweithredu.
10. Beth ddylai fod yn ymwybodol pan fydd dogfennau GMP yn cael eu cyhoeddi a'u hailgylchu?
A: (1) Rhaid i ddogfen a gyhoeddir gael ei chofnodi, a'i llofnodi gan y derbynnydd. (2) Rhaid adennill dogfennau anarferedig ar y diwrnod y gweithredir y ddogfen newydd, a rhaid cadw cofnodion; (3) Mae dogfennau anarferedig yn cael eu dinistrio neu eu harchifo gan yr adran rheoli dogfennau.
11. Beth yw tair cydran darged GMP?
A: (1) Cadw gwallau dynol i'r lleiaf posibl; (2) Osgoi llygredd ar gyfer cyffuriau; (3) adeiladu system sicrhau ansawdd trwyadl, gwarantu ansawdd y cynhyrchion.
12. Beth yw CRhT, a pha gynnwys y mae'n ei gynnwys?
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. Beth yw SOP, a pha gynnwys y mae'n ei gynnwys?
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. Beth yw SOR, a pha gynnwys y mae'n ei gynnwys?
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. Sut i gynnal-hunanarolygiad GMP?
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. Sut i ddosbarthu'r dogfennau GMP cyfredol?
A: Rhennir dogfennau GMP cyfredol yn ddau gategori, sef dogfennau safonol a dogfennau cofnod, taleb ac adroddiad. Yn y categori dogfennau safonol, mae'n cynnwys (1)dogfennau safonol technegol; (2) dogfennau safonol rheoli; (3) dogfennau safonol gweithio.