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) Zahtevati od farmaceutske industrije ne samo da dokaže efikasnost lekova, već i da dokaže bezbednost lekova.
(2) Require pharmaceutical industries to report drugs' adverse reaction to FDA
(3) Zahtijevati od farmaceutske industrije da implementira praksu proizvodnje lijekova i upravljanja kvalitetom
1963. Kongres Sjedinjenih Država proglasio je prvi GMP u svijetu.
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. Koja je središnja misao GMP?
O: Centralna smjernica za implementaciju GMP-a je: formiranje bilo kojeg kvaliteta lijeka je dizajnirano, a ne testirano. Da bismo izvršili ovo centralno vođenje, 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. Koje su razlike između GMP i TQC?
O: TQC je potpuna kontrola kvaliteta, GMP je materijalizacija u proizvodnji lijekova. TQC se određuje prema podacima, ključ je sveobuhvatan, GMP zahtijeva da sve bude dokumentirano, ključ je rigorozan. Stoga je TQC vodič za GMP, GMP je implementirano rješenje.
4. What's the differences between QA and QC?
O: QA je skraćenica za osiguranje kvaliteta, njegov glavni posao je formulacija dokumenata, istraživanje, nadzor i pregled i izdavanje gotovog proizvoda. QC je skraćenica za kontrolu kvaliteta, koja koristi mikrobiologiju, fiziku i hemijsku identifikaciju i druge aspekte za kontrolu kvaliteta.
5. Koji su glavni sadržaji GMP-a?
O: Može se sažeti kao wetware, hardver, softver. Wetware je osoblje, hardver je postrojenje, postrojenje i oprema, softver je organizacija, sistem, tehnologija, rad, higijenski standard, evidencija, edukacija i drugi propisi upravljanja.
(1) Osoblje: potreban je određeni broj stručnjaka, svo osoblje treba da pohađa obuku o stručnom znanju i obuku o 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 poglavlja se sastoji od GMP i kada će se implementirati?
O: GMP ima ukupno 14 poglavlja i 88 članaka i implementiran je od 1. avgusta 1999. Najnovija verzija je verzija 2010.
7. Koji uslovi treba da budu ispunjeni za pokretanje preduzeća za proizvodnju lekova
O: Pokretanje preduzeća za proizvodnju farmaceutskih proizvoda mora imati sledeće uslove:
(1) Posjedovanje pravno kvalifikovanih farmaceutskih tehničara, inženjerskih tehničara i odgovarajućeg stručnog radnika
(2) Posjeduje pogone, objekte i higijensko okruženje pogodno za svoju farmaceutsku proizvodnju
(3) Posjedovanje institucije, osoblja i potrebnih instrumenata i opreme koja može vršiti upravljanje kvalitetom i inspekciju kvaliteta za proizvodnju lijekova
(4) Imati pravila i propise za osiguranje kvaliteta lijekova
8. Zašto se kaže da su GMP dokumenti udžbenik obuke kadrova?
O: Implementacija GMP-a mora biti kombinovana sa stvarnim stanjem kompanija, uključuje organizaciju, sastav i kvalitet osoblja, proizvodnju i mnoge druge faktore. Za generalštab je važnije da će kroz obuku iz osnovnih GMP znanja znati da se pridržavaju pravila u svakodnevnom procesu rada, odnosno da u potpunosti ovladaju osnovnim radnim vještinama i GMP zahtjevima.
9. Zašto u GMP dokumentima treba navesti datum odobrenja i datum izvršenja?
O: Nemoguće je započeti izvršenje na dan odobrenja GMP dokumenta. Mora ispuniti procedure izdavanja dokumenata. Ovaj proces traje određeno vrijeme, a u isto vrijeme i novi odobreni dokument zahtijeva obuku. Dakle, postoji jaz između vremena odobrenja i vremena izvršenja.
10. Čega treba imati na umu kada se GMP dokumenti izdaju i recikliraju?
O: (1) Izdati dokument mora biti evidentiran i potpisan od strane primaoca. (2) Zastarjele isprave vraćaju se danom sastavljanja nove isprave, o čemu se vodi evidencija; (3) Zastarjele dokumente uništava ili arhivira odjel za upravljanje dokumentima.
11. Koje su tri ciljne komponente GMP-a?
O: (1) Smanjite ljudske greške na minimum; (2) Izbjegnite zagađenje drogama; (3) izgradite rigorozan sistem osiguranja kvaliteta, garantirajte kvalitet proizvoda.
12. Šta je SMP i koji sadržaj uključuje?
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. Šta je SOP i koji sadržaj uključuje?
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. Šta je SOR i koji sadržaj uključuje?
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 izvršiti GMP samo{1}}inspekciju?
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 klasificirati trenutne GMP dokumente?
O: Trenutni GMP dokumenti su podijeljeni u dvije kategorije, standardni dokumenti i dokumenti, vaučeri i izvještaji. U kategoriji standardnih dokumenata uključuje (1) tehničke standardne dokumente; (2) standardna dokumenta upravljanja; (3) radna standardna dokumenta.