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质量协议书
Quality
agreement
甲方(进货单位)
:
Party A (Purchase)
乙方(供货单位)
:
Party B(Supplier)
供应双方根据
《中华人民共和国管理法》
、
< br>《中华人民共和国产品质量法》
、
《药
< br>品生产质量管理规定》及有关法律、法规的要求,明确药品经营质量责任,保证
药
品质量,经甲乙双方协商达成如下协议,并共同遵守。
According
to
“
thePeople'sRepublicofChina(PRC)
management
law
”,
“
PRC
product
quality law
”, “Good
Manufacturing Practice”
and related
laws and regulations, clear
drug supply
quality responsibility and ensure drug quality,
both sides
have reached
the following agreement and must abide
by.
一、甲方义务
Party A responsibility
1
、甲乙双方同意各自充分考虑对方的需求,相互交换产品质量的必要情报
。
Both
sides
agree
to
fully
consider
each
other
’
s
demand,
exchange
necessary
information of
product quality.
2
、甲方收到乙方供货产品时应根据随货同行的原厂检验报告和《销售凭证》验
收,发现
短少、破损或外包装损坏时应及时通知乙方,乙方负责处理有问题
的产品。
Party A must do primary test according
to manufacturer COA and
“sales
voucher”
along
with
product.
If
found
any
loss
or
broken,
informs
Party
B
immediately.
Party B is
responsible for handling problem
product.
3
、甲方收货后及
时检验,如有质量问题应对乙方提出,如经双方确认,为乙方
质量问题,甲方有权退货。
Party
A
must
test
in
time
after
receiving
product.
If
quality
has
any
problem,
informs Party B and
verifies by both sides. Party A has the right to
reject product if
quality has
problem.
4
、甲方根据本公
司规定的供应商质量评估和批准标准管理要求对乙方进行审计
和评估。
< br>
Party A audit and evaluate Party B as
their own supplier quality evaluation and
permission procedure.
二、乙方义务:
Party B
responsibility
1
、
甲乙双方同意各自充分考虑对方的需求,相互交换产品质量的必要情报。甲
方有义务向乙
方提供所需产品的质量标准,乙方在不违反《药品法》的前提
下提供相应产品;乙方所提
供的产品,必须满足现行中国药品标准。
Both
sides
agree
to
fully
consider
each
other
’
s
demand,
exchange
necessary
information
of
product
quality.
Party
A
has
responsibility
to
supply
product
specification and Party B offers
products on the premise of abide by
“
Drug
Act
”
. The
product
must meet with currentChina drug
standard.
2
、乙方应为合
法的生产或经营企业。乙方向甲方提供合法有效并加盖本企业公
章的营业执照、组织机构
代码证、税务登记证、药品生产许可证或药品经营
许可证等有效证件供甲方审验资质。乙
方在年审、换证或变更证照时,应及
时向甲方提供新证照复印件并加盖本企业公章。
p>
Party
B
must
be
a
legal
manufacturer
or
business
enterprise.
Party
B
offer
qualifications
including
business
license,
organization
code
certificate,
tax
registration certificate, GMP
certificate or GSP certificate affixed withthe
official
seal
of
the
enterprise
for
audit.
Party
B
must
timely
provide
newcopycertificateaffixed
withthe
official
seal
of
the
enterprise
when
annual
examination, renew or
change license.
3
、乙方供应的商品必须符合质量标准和有关质量要求,附产品合格证,符合国
家包装、标
签、说明书、标志标识的有关规定和货物运输的要求。
The product
supplied by
Party B must meet with
specification & related quality
demand
and along with qualified certificate. Also, the
product must comply with
nationalrequirements
of
packaging,labels
and
instruction
and
requirements
of
goods transportation
condition.
4
、乙方应提
供甲方对供应商质量评估和批准标准管理要求予以配合,按甲方提
出的合理的缺陷要求进
行整改,整改完成后经甲方确认列为合格供应商后,
方可采购。
Party B must cooperate with Party Ato
complete theParty B qualityevaluation &
approvalprocedure and finish CAPAs.
Purchase from Party B after evaluation and
permission it as qualified
supplier.
5
、乙方向甲方
销售商品时,应开具加盖本企业销售或发货公章的《销售凭证》
和本批合格的原厂检验报
告随货同行给甲方,供验明商品的合法来源。
《销售
凭证》应标
明供货单位名称、货物名称、规格、生产厂商、生产批号、生产
日期、有效期、数量、储
存条件等内容。若乙方不能及时提供《销售凭证》
将会影响甲方收货、验收和向乙方汇付
货款。
“
S
ales
voucher”
with stamped and COA must be
along with products to identify
its
legal
resource.
“
S
ales
voucher”
including
supplier
name,
product
name,
specification,
manufacturer,
Batch
No.,
manufacturing
date,
valid
date,
quantity
and
storage
condition.
If
Party
B
cannot
supply
“
Sales
voucher
”
on
time,
it
will
effect Party A
’
sreceipt,acceptanceandremittancepaym
ent.
6
、乙方向甲方销售商品时
,应当按照有关规定储存和运输,以保证产品质量。
若乙方不能做到按照有关规定储存和
运输,由此造成的拒收退货、产品质量
问题、经济损失或药监罚没由乙方负责。
Party
B
must
storage
and
transport
asrelevant
provisions
to
ensure
product
quality.
Party B
must responsible for product rejection, product
quality problem,
economic loss or any
penaltiesand forfeitures by SFDA that caused by
improper
storage or transport.
7
、乙方供应的商品应符合甲方效期
及数量批号比例要求。来货商品有效期一年
以内的,生产日期距收货日期不得超过
3
个月;有效期一年以上的,生产日
期距收货
日期不得超过
6
个月。
来货
10
件以下的只能为一个批号;
50
件以下
不得超过
2
个批号。
The supplied products must comply with
shelf life and quantity& Batch No. ratio
as
Party
A
’
s
demand.
The
incominggoodsvalid
date
iswithin
one
year,the
date
ofproduction must not exceed 3
monthsfrom date of receipt; valid date isabove
one
year,the
date
ofproduction
must
not
exceed
6
monthsfrom
the
date
of
incoming
goods is less than 10 pieces, it can only
foronebatch number;if
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