认证资讯

FDA警告信:杭州Sunking Nonwovens Co., Ltd.

近日,FDA官网发出对杭州Sunking Nonwovens Co., Ltd.的警告信,警告信列出该公司违反药品cGMP的缺陷如下:

  • 未对检验即放行,包括但不限于活性成分的鉴定

  • 多个批次委托第三方检验的COA(检验报告)结果均一模一样,FDA对此表示担忧

  • 未对入厂原辅料进行检验

  • 未确认供应商检验的可靠性而依赖供应商的检验结果

  • 没有稳定性数据支持产品的有效期

  • 未开展工艺验证

  • 未开展持续工艺确认

  • 未建立充分的程序以使质量部门充分行使其职能

  • 委托检验未签订质量协议


FDA最后强调,委托商,包括委托生产、委托检验、委托包装和贴标商,将被视为生产的延伸。因此, 生产商需对最终放行负责。无论与委托商签订何种协议,生产商需对所生产的药品质量负责


该警告信摘译如下:


Warning Letter 320-19-10

Hangzhou Sunking Nonwovens Co., Ltd.

杭州Sunking Nonwovens有限公司

No. 888 Chongchao Rd., Chongxian Industrial Area, Hangzhou, Zhejiang, 311108 China

浙江省杭州市崇贤工业区崇超路888号

 

1.      Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

贵公司在每批产品放行前,未能进行适当的实验检查以确定是否符合产品的最终标准, 包括每种活性成分的鉴别和剂量 (21 cfr)211.165(a))。

 

Your firm released over-the-counter (OTC) (b)(4) drug products without appropriate quality control release testing, including but not limited to, the identity testing of (b)(4) active ingredient.

贵公司在没有适当质量控制的情况下放行非处方药 (OTC) (b)(4) 药品, 但包括但不限于 (b)(4) 活性成分的鉴定。

 

In addition, we have concerns about the validity of test results for your finished drug product. Reports from your contract laboratory included strength test results of (b)(4) active ingredient and microbial test results (total bacterial and total fungal counts) that were identical for (b)(4) batches of your (b)(4) drug product that were shipped for distribution to the U.S. market.

此外, 我们对你们成品药品检验结果的有效性表示担忧。来自你们合同实验室的报告显示,分销至美国市场的XX批XX产品,包括 (b)(4) 活性成分的含量和微生物检验结果 (细菌总数和真菌总数),每批都是相同的。

 

2.      Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)).

贵公司没有进行至少一项检验来鉴定药品中的每个组分。贵公司也未能以适当的时间间隔来验证和建立原辅料供应商检验分析的可靠性。(21 cfr 211.84(d)(1) 和 (2))

 

Your firm lacked testing of incoming raw materials, used in the manufacturing of your drug product, including active pharmaceutical ingredients and other components, for their identity, strength, and other quality attributes. Your firm also relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of the suppliers’ analyses through appropriate validation.

贵公司未对用于药品生产的入厂物料进行检验, 包括活性药物成分和其他成分, 以确定其鉴定、含量和其他质量属性。贵公司还未能通过适当的验证来建立供应商检验的可靠性,而依赖于供应商的检验报告(COA)。

 

3.      Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).

贵公司未能开展适当稳定性试验以支持药品有效期(21 cfr 211.137(a))。

 

Your firm has not established a stability program, including written procedures. Your firm also did not have stability data to support the (b)(4) expiration dates assigned to your OTC drug product. Without stability data, you cannot assure the quality of your drug products throughout their labeled shelf lives.

贵公司尚未建立稳定性试验程序,包括书面规程。也没有稳定性数据来支持OTC药品的 (b)(4) 有效期。如果没有稳定性数据, 你们无法确保药品在整个有效期内的质量。

 

4.      Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

贵公司未能建立生产和过程控制的书面程序, 以确保所生产的药品具有其声称或应有鉴定、含量、质量和纯度 (21 cfr 211.100(a))。

 

Your firm has not validated the processes used to manufacture your drug products. Your firm did not perform process qualification studies and lacks an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.

贵公司未能验证你们的药品生产工艺。贵公司没有进行工艺确认研究, 并且缺乏持续的计划来监测工艺控制以确保稳定的生产操作和稳定的药品质量。

 

See FDA’s guidance document, Process Validation: General Principles and Practices, for general principles and approaches that FDA considers appropriate elements of process validation, at https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf.

工艺验证的和方法详见FDA指南:工艺验证: 一般原则和规范https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf 

 

5.      Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

贵公司未能建立适当的质量部门,负责并有权批准或拒绝所有原辅料、药品容器、密封部件、中间产品、包装材料、标签和药物成品 (21 cfr 211.22(a)).

 

Your firm lacks an adequate quality unit. You have not established written procedures for numerous functions of the quality unit, including but not limited to, quality unit operations, batch release, change control, complaints, supplier qualification, recalls, and annual product reviews. During the inspection, you indicated that your firm lacks a quality agreement describing the roles, responsibilities, and procedures to be followed by you and your contract laboratory regarding component and final product testing.

贵公司缺乏充分的质量部门。你们尚未为质量部门的许多职能建立书面程序, 包括但不限于质量部门运转、批放行、变更控制、投诉、供应商确认、召回和年度产品回顾。在检查过程中, 你们表示贵公司缺乏质量协议以说明你们和合同实验室在组分和最终产品检验方面应遵循的角色、责任和程序。

 

Use of Contract Laboratories

合同实验室的使用

 

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors, such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer. As such, you are responsible for making final release decisions.

药品的生产必须符合CGMP。FDA知道许多药品生产商使用独立的委托商, 如生产工厂、检验实验室、包装商和贴标商。FDA将委托商视为生产商的延伸。因此, 你们对最终放行负责。

 

You are responsible for the quality of drugs you produce, regardless of agreements in place with your contract facilities. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document, Contract Manufacturing Arrangements for Drugs: Quality Agreements, at: https://www.fda.gov/downloads/drugs/guidances/ucm353925.pdf.

无论与委托商签订何种协议,你们对所生产的药品质量负责。你们必须确保药品生产符合 FD & C法案 501(a)(2)(B), 以确保安全、鉴定、剂量、质量和纯度。见FDA指南_药品委托生产协议:质量协议, https://www.fda.gov/downloads/drugs/guidances/ucm353925.pdf

 

Quality Systems Guidance

质量体系指南

 

Your firm’s quality systems are inadequate. For guidance on establishing and following CGMP compliant quality systems, see FDA’s guidance’s: Q8(R2) Pharmaceutical Development,

at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; Q9 Quality Risk Management, at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; and Q10 Pharmaceutical Quality System, at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

贵公司的质量体系不足。有关建立和遵循符合CGMP标准的质量体系的指南, 请参阅FDA指南: Q8(R2) 药物开发, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; Q9质量风险管理http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm;和 Q10药品质量体系,  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm。

 

Inadequate Response

不充分的回复

 

Your response to the FDA inspection did not provide sufficient details or evidence that your firm will remediate your operations to ensure compliance with CGMP.

你们对FDA检查的回复没有提供足够的细节或证据证明贵公司将纠正你们的操作以确保符合CGMP。 

未经允许,不得擅自仿造或转载,违者依法追究
郑重声明:本站所有内容归PHEXCOM 版权所有copyright 2015-2020 imagination advertizing all rights reserved