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) Od farmacevtske industrije zahtevati ne le dokazovanje učinkovitosti zdravil, temveč tudi varnost zdravil.
(2) Require pharmaceutical industries to report drugs' adverse reaction to FDA
(3) Od farmacevtske industrije zahtevati izvajanje praks proizvodnje zdravil in vodenja kakovosti
Leta 1963 je ameriški kongres razglasil prvi GMP na svetu.
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. Kaj je osrednja misel GMP?
O: osrednja smernica izvajanja GMP je: oblikovanje katere koli kakovosti zdravila je zasnovano, ne testirano. Za izvedbo tega osrednjega vodnika moramo:
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. Kakšne so razlike med GMP in TQC?
O: TQC je popolna kontrola kakovosti, GMP je materializacija v proizvodnji zdravil. TQC določajo podatki, ključ je na splošno, GMP zahteva, da je vse dokumentirano, ključ je strog. Zato je TQC vodilo GMP, GMP je implementirana rešitev.
4. What's the differences between QA and QC?
O: QA je okrajšava za zagotavljanje kakovosti, njegovo glavno delo je oblikovanje dokumentov, preiskava, nadzor ter pregled in izdaja končnih izdelkov. QC je okrajšava za nadzor kakovosti, ki uporablja mikrobiologijo, fiziko in kemijsko identifikacijo ter druge vidike za nadzor kakovosti.
5. Kakšne so glavne vsebine GMP?
O: Lahko ga povzamemo kot mokro opremo, strojno opremo, programsko opremo. Wetware je osebje, strojna oprema je naprava, objekt in oprema, programska oprema je organizacija, sistem, tehnologija, delovanje, higienski standard, evidentiranje, izobraževanje in drugi predpisi upravljanja.
(1) Osebje: potrebujejo številne strokovnjake, vse osebje se mora udeležiti usposabljanja za strokovno znanje in usposabljanja za 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. Koliko poglavij je sestavljena iz GMP in kdaj se bo izvajala?
O: GMP ima skupaj 14 poglavij in 88 člankov in se izvaja od 1. avgusta 1999. Najnovejša različica je različica 2010.
7. Kateri pogoji morajo biti izpolnjeni za ustanovitev podjetja za proizvodnjo farmacevtskih izdelkov
O: Zagon podjetja za proizvodnjo farmacevtskih izdelkov mora imeti naslednje pogoje:
(1) Imeti pravno usposobljene farmacevtske tehnike, inženirske tehnike in ustreznega kvalificiranega delavca
(2) Imeti obrate, objekte in higiensko okolje, primerno za svojo farmacevtsko proizvodnjo
(3) Imeti institucijo, osebje ter potrebne instrumente in opremo, ki lahko izvajajo upravljanje kakovosti in inšpekcijo kakovosti proizvodnih zdravil
(4) Imeti pravila in predpise za zagotavljanje kakovosti zdravil
8. Zakaj pravimo, da so dokumenti GMP učbenik za usposabljanje osebja?
O: Izvajanje GMP mora biti združeno z dejanskim stanjem podjetij, vključuje organizacijo, sestavo in kakovost osebja, proizvodnjo in številne druge dejavnike. Za generalne kadre je bolj pomembno, da bodo skozi osnovno usposabljanje GMP znali upoštevati pravila v vsakodnevnem delovnem procesu, se pravi, da morajo v celoti obvladati osnovne delovne veščine in zahteve GMP.
9. Zakaj morajo dokumenti GMP navesti datum odobritve in datum izvedbe?
O: Nemogoče je začeti z izvajanjem na dan odobritve dokumenta GMP. Izpolniti mora postopke za izdajo dokumentov. Ta proces traja določen čas, hkrati pa je za novo potrjeno dokumentacijo potrebno tudi usposabljanje. Torej obstaja vrzel med časom odobritve in časom izvedbe.
10. Kaj je treba upoštevati pri izdaji in recikliranju dokumentov GMP?
O: (1) Izdani dokument mora biti zabeležen in podpisan s strani prejemnika. (2) Zastarele listine se izterjajo z dnem, ko se nova listina izvrši, in vodi evidenca; (3) Zastarele dokumente uniči ali arhivira služba za upravljanje z dokumenti.
11. Katere so tri ciljne komponente GMP?
O: (1) Človeške napake zmanjšajte na minimum; (2) Izogibajte se onesnaženju z drogami; (3) zgradite strog sistem zagotavljanja kakovosti, zagotovite kakovost izdelkov.
12. Kaj je SMP in kakšne vsebine vključuje?
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. Kaj je SOP in kakšne vsebine vključuje?
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. Kaj je SOR in kakšne vsebine vključuje?
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. Kako izvesti samopregled{1}} 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. Kako razvrstiti veljavne dokumente GMP?
O: Trenutni dokumenti GMP so razdeljeni v dve kategoriji, standardni dokumenti in dokumenti evidence, kupona in poročila. V kategorijo standardnih dokumentov vključuje (1)tehnične standardne dokumente; (2) standardne dokumente upravljanja; (3) delovne standardne dokumente.