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) Jeħtieġu li l-industriji farmaċewtiċi mhux biss jippruvaw l-effettività tad-drogi, iżda wkoll biex jipprovaw is-sigurtà tad-drogi.
(2) Require pharmaceutical industries to report drugs' adverse reaction to FDA
(3) Jeħtieġ li l-industriji farmaċewtiċi jimplimentaw il-produzzjoni tad-droga u l-prattiki tal-ġestjoni tal-kwalità
Fl-1963, il-kungress tal-Istati Uniti pproklama l-ewwel GMP fid-dinja.
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. X'inhu l-ħsieb ċentrali ta 'gwida tal-GMP?
A: il-ħsieb ċentrali ta 'gwida tal-implimentazzjoni tal-GMP huwa: il-formazzjoni ta' kwalunkwe kwalità tad-droga hija mfassla, mhux ittestjata. Biex inwettqu din il-gwida ċentrali, irridu:
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. X'inhuma d-differenzi bejn GMP u TQC?
A: TQC huwa totalment kontroll tal-kwalità, GMP huwa materjalizzazzjoni fil-produzzjoni tal-mediċina. TQC huwa deċiż mid-dejta, iċ-ċavetta hija ġenerali, il-GMP jeħtieġ li kollox jiġi dokumentat, iċ-ċavetta hija rigoruża. Għalhekk, TQC hija l-ħsieb ta 'gwida tal-GMP, GMP hija s-soluzzjoni implimentata.
4. What's the differences between QA and QC?
A: QA hija l-abbrevjazzjoni għall-assigurazzjoni tal-kwalità, ix-xogħol ewlieni tagħha huwa l-formulazzjoni tad-dokumenti, l-investigazzjoni, is-superviżjoni u r-reviżjoni u l-ħruġ tal-prodott lest. QC hija l-abbrevjazzjoni għall-kontroll tal-kwalità, li tutilizza l-mikroboloġija, il-fiżika u l-identifikazzjoni kimika u aspetti oħra biex tikkontrolla l-kwalità.
5. X'inhuma l-kontenuti ewlenin tal-GMP?
A: Jista 'jinġabar fil-qosor bħala wetware, ħardwer, softwer. Wetware huwa persunal, ħardwer huwa impjant, faċilità u tagħmir, softwer huwa organizzazzjoni, sistema, teknoloġija, tħaddim, standard iġjeniku, reġistrazzjoni, edukazzjoni u regolamenti oħra ta 'ġestjoni.
(1) Persunal: jeħtieġ numru ta 'professjonisti, l-istaff kollu jeħtieġ li jattendu taħriġ ta' għarfien professjonali u taħriġ ta 'għarfien 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. Kemm-il kapitoli jikkonsisti l-GMP u meta jiġi implimentat?
A: GMP għandu 14-il kapitolu u 88 artiklu b'kollox, u ġie implimentat mill-1 ta 'Awwissu, 1999. L-aħħar verżjoni hija l-verżjoni 2010.
7. Liema kundizzjonijiet għandhom jiġu sodisfatti biex tinbeda intrapriża ta 'produzzjoni farmaċewtika
A: Il-bidu ta' intrapriża ta' produzzjoni farmaċewtika għandu jkollu l-kundizzjonijiet li ġejjin:
(1) Li jkollok tekniċi tal-ispiżerija kwalifikati legalment, tekniċi tal-inġinerija u ħaddiem tas-sengħa rilevanti
(2) Wara li pjanti, faċilitajiet u ambjent iġjeniku adattati għall-produzzjoni farmaċewtika tiegħu
(3) Li jkollok istituzzjoni, persunal, u strument u tagħmir meħtieġ li jistgħu jagħmlu ġestjoni tal-kwalità u spezzjoni tal-kwalità għal drogi tal-produzzjoni
(4) Li jkollok regoli u regolamenti biex jiżguraw il-kwalità tal-mediċini
8. Għaliex ngħid li d-dokumenti GMP huwa l-ktieb tat-taħriġ tal-persunal?
A: L-implimentazzjoni tal-GMP għandha tiġi kkombinata mas-sitwazzjoni attwali tal-kumpaniji, tinkludi organizzazzjoni, kompożizzjoni tal-persunal u kwalità, produzzjoni u ħafna fatturi oħra. Għall-persunal ġenerali, ħaġa aktar importanti hija li permezz ta 'taħriġ bażiku ta' għarfien tal-GMP, ikunu jafu kif isegwu r-regoli fil-proċess tax-xogħol ta 'kuljum, fi kliem ieħor, jeħtieġ li jegħlbu kompletament il-ħiliet bażiċi tax-xogħol u r-rekwiżiti tal-GMP.
9. Għaliex id-dokumenti tal-GMP jeħtieġ li jispeċifikaw id-data tal-approvazzjoni u d-data tal-eżekuzzjoni?
A: Huwa impossibbli li tibda l-eżekuzzjoni fil-jum tal-approvazzjoni tad-dokument GMP. Jeħtieġ li tissodisfa l-proċeduri tal-ħruġ tad-dokumenti. Dan il-proċess jieħu ċertu ammont ta 'żmien, u fl-istess ħin, dokument approvat ġdid jeħtieġ ukoll taħriġ. Għalhekk hemm vojt bejn il-ħin tal-approvazzjoni u l-ħin tal-eżekuzzjoni.
10. X'għandu jkun konxju meta dokumenti GMP maħruġa u riċiklati?
A: (1) Id-dokument maħruġ irid ikun rekord, u ffirmat mir-riċevitur. (2) Dokumenti skaduti għandhom jiġu rkuprati fil-jum meta jiġi esegwit id-dokument il-ġdid, u għandhom jinżammu rekords; (3) Dokumenti skaduti huma meqruda jew arkivjati mid-dipartiment tal-ġestjoni tad-dokumenti.
11. X'inhuma t-tliet komponenti fil-mira tal-GMP?
A: (1) Żomm l-iżbalji umani għal minimu; (2) Evita t-tniġġis għad-drogi; (3) tibni sistema rigoruża ta 'assigurazzjoni tal-kwalità, tiggarantixxi l-kwalità tal-prodotti.
12. X'inhu SMP, u liema kontenut jinkludi?
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. X'inhu SOP, u liema kontenut jinkludi?
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. X'inhu SOR, u x'kontenut jinkludi?
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. Kif twettaq l-ispezzjoni GMP awto-?
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. Kif tikklassifika d-dokumenti GMP attwali?
A: Id-dokumenti attwali tal-GMP huma maqsuma f'żewġ kategoriji, dokumenti standard u dokumenti ta 'rekord, vawċer u rapport. Fil-kategorija tad-dokumenti standard, tinkludi (1)dokumenti standard tekniċi; (2)dokumenti standard ta 'ġestjoni; (3) dokumenti standard tax-xogħol.