˿ͻԹ˾ῼб¶⼰ķ£
*	Ʊ¶⣺
o	¼⣺¼Ѷȴ󣬸¼ȫ棬ұʼ׿һ
д¼ݲȫ棬޼̡
o	ļ⣺ļ·١ջڴȱݣļ
޽ˣ·ļϹ˾ʵ飬޷
ﵽļҪ
o	⣺δƫOOS  OOTͻɣ
֤ȱŶȣδ֤ؼղ֤⣬δȷ
޶ȺͿƷ
o	ֳ⣺ֳڽ϶⣬ˮܵ⼣Ӱ
ͻ۸С
o	Ա⣺QAQC Աרҵ㣬ΪУҲԱ
̬Ȳ棬ḡȱġ
*	˼·뷽
o	˼·ʵչ򻯹ֻԹؼ
֤ѧƷȸӡ
o	Ա QA ˣжСĵ QA Ա
зͬʱǿԱĹͼල
o	ע⣺עͲƷص RI Բⶨ
֤⣬׼֤
o	ʵԣȷǢʵ֤޶⣬ѧ
Ʒ
*	Ĵʩ
o	¼ģž󲹼¼ȷ¼ȫ桢ʵ¼
ݣݼ̡
o	ļģ淶ļ·١̣ȷļȷ
нˣ޸ļԷϹ˾ʵ
o	ģƫOOS  OOTƹ֤棬ȷ
֤Ĳ޶ȺͿƷ
o	ֳģֳ⣬ˮܵ⼣
o	ģ߹ȶԣж֤ȷչ
ʵʲһ£ QC 
o	豸ɹҪ󣬲Ӳ豸
صϡ
*	
o	Σ4000 򶩵Σع
o	ͬͬԼ򵥣ƫ˾ּ
ϽʵʿɲִС
o	Ӱ죺ǰӰ辡
*	
o	ϼ¼ۣŲڿʵ¼ϣȷ
ļӦԽʵʲļ⡣
o	ԣ 20 ˣ QA ţ
ʹԱѯ㡢ƼдзŵǸѧ
word ½
Ҫͻ⸴ GMP ϵķ
һϢ
*	⣺ͻ⸴̡GMP ϵļ 4000 򶩵Ϲ
*	ıͻΪῼչƣƲӰ충
ῼʧ
*	λԱ˵ Aκܣ˵ BԬ˵ C˵
 DϺ˵ E
ƺĸſ
1.	ƷͻžƣQC 
2.	ƽۣӲԼ 90%ݡļ¼ΪĶ̰
3.	ؼͻ˵ڽ 1 £רΪ 4000 Ŀ
ҩ걨
4.	̬ȣҪʵɣܾͼ
Ʊ¶ĺ
һ¼ʵ
1.	¼ձΪºдһݣ¼¼ʱ
ƥ
2.	ʪȡѹȸ¼ȱʧӭʱͳһʼһۿɱ
3.	¼ݲȱټ̣ؼͻأ
4.	̬ȲʣٺۼƷȫ治
ļ
1.	ļ·١ȱʧ޽ˡļִ
2.	ļհ / ģ壬빫˾ܡȫִ

3.	滻ҳֽɫһµȵͼ󣬵ļϵȫ
4.	δƫOOSOOTƷж ƷǼģ
ġ
֤빤
1.	֤޿ŶȣδǹؼղʡڶȥЧ
2.	֤ȱʧ100 + Ʒֹ޲޶ȡʡת
֤
3.	ȶ֤ԭøδȶԣƲ25 12 £

4.	ղȶ弴ա޹̶׼¼빤չһ
ģԱ
1.	QA/QC ŶרҵΪУ˽øҵ
2.	QA ʤḡ̬ȷܡԵ̬Ӧԣͻ

3.	Աò㣬һ˶ڣƷֱжݲʵ
4.	йУ壬зѽ
壩ֳӲ
1.	ֳˮܵʴأ޷ܼ
2.	豸ȱʧȱ䣬롢豸ʶȫ
3.	ӫ޷ RI ԣؼȱ
Ʒķ
1.	RI Լȱδ׼޷
2.	ԭøȶδչƷȫȱʧ
3.	ø buffer δ룬 GMP Ʒ淶
ġ˼·ԭ
1.	ٲ¼ʵִСأհҩ GMP ȫױ׼
2.	ѧؼ֤ RI ԣͨ÷ƽ̨ȡظ
๤
3.	Աȣϸ QAƸ / ø桢ĵ

4.	ץ߽ǣȽ RI ԡȶԡ֤Ӳ
5.	ʵʣøԭƶ GMP ׼äĿԱҩҵ
塢Ĵʩ
һ¼
1.	ֹº󲹼¼ִ ղռ¼
2.	ʪȡѹ豸ʹõȸ¼ȷʱ߼Ǣ
3.	ȫݼ̣ͳһļʽž滻ҳɫ
4.	ϺǣͷǢʵ
ļϵ
1.	޶ļϹ˾ʵʲܡԱգִ
2.	淶ļշ١鵵̣ǩۼ
3.	ƫOOSOOT ļ¼ʵд
֤
1.	RI ԣԭø / Ʒ׼ɷ֤ / ɹ
豸
2.	ȶԣԭøȶоѧƷ򻯼Ŀø
ڶأ
3.	֤ȷ޶ȣǩʡת֤
4.	֤ؼʡڶȥݣ
ģԱ֯
1.	 QA ʤQA ŶȫŻ
2.	ϺƸԲ 20 ˣ㡢Ƽ
3.	ȴзǸ QA ˲ţҪø + 
4.	ȷ QA Ϊ󷽣ԽӿͻҪз / 
壩ֳӲ
1.	ֳʴܵ
2.	ɹ豸롢ʶ
3.	Ƚ RI Լ豸⣨з豸ȵʹã
4.	ƽȶԲԵظԹԶ
Ʒ빤Ż
1.	ø buffer ֱֿȶԣԱҵ
2.	Żգ̶׼һ
3.	з˴ĿʼϣǰԽ GMP Ҫ

1.	4000 򶩵ȫƲӰִУῼ
2.	ͬƫҷϽɲִУֳ
3.	ֳ֧ҷžΪĿϸ񵫿͹
4.	Ϊ壬֧źȿͻ GMP Ŀ
ߡһ
1.	ϺĿŻƽƸͳ֤
2.	κܣз RI ֤ȶԷƣʵ濪
3.	ԬԽӿͻͬ豸ɹ븶
4.	ȫԱͳһھϽ̬ȣ̬ƽ
5.	ȼRI Լԭøȶԡ֤ļϵԱ


