shared third party audit共享第三方审计

beiwei5du

Shared Supplier Audits
By Helena Champion, Drug Quality Assurance | September 6, 2012

A new day for supply chain quality

Drug and device companies I work with are often resource- and time-constrained and, while we audit drug substance and drug product contract manufacturing organizations, we may give less attention to other materials such as excipients and chromatography resins, especially during early clinical development. However there are safety risks with some commodity excipients and materials, such as glycerin and gelatin capsules, to name some recent adulterated materials in the headlines and we don’t know what material may be adulterated next! It makes sense to use shared resources that are available from independent organizations to help qualify material suppliers and to monitor supply chain issues.

Most adulterated products come from supply chains unknown to the drug or device manufacturer. The European Directive 2011/62/EU (prevention of falsified medicinal products) requires drug manufacturers to verify compliance by manufacturers and distributors of active substances with GMP and GDP by means of onsite audits. The FDA has indicated that we should know the full supply chain for materials at risk and they are now reviewing supplier qualification more carefully during inspections.

Supplier qualification of any one material is multifaceted and difficult for a number of reasons:

• Qualification of a supplier is specific to a single manufacturing location and for specific materials and manufacturing operations performed at that location.
• The actual site of manufacture of a chemical or component may be different from the site where it is packaged in small quantities for the customer
• Often a number of distributors and brokers are involved with the supply of a chemical or component
• Some suppliers to the pharmaceutical industry get their materials from brokers who may change material sources at any time to reduce costs. The FDA does not require brokers of excipients to register, and very few of them have ever been inspected. How can the supply chain be verified?
• It is usually not clear on the certificate of analysis where testing was performed.
  

It requires considerable quality expertise and resources to establish an effective supplier qualification program, to perform supplier audits and to discover and verify the full supply chain for materials.

How can we do our best to avoid adulterated and low quality materials? Risk assessment is useful to prioritize and decide which materials suppliers require more attention. We know we need to purchase materials from suppliers that deal with high-quality manufacturers, distributors and brokers who know and monitor the entire supply chain, to avoid risk of adulteration, but that is easier said than done. How do we find out the supply chain and whether our supplier really monitors the supply chain, other than by audit after extensive confidentiality negotiations?

It makes sense to share this effort with other companies using the same materials by using whatever shared independent industry resources are available, to ensure we are using well qualified suppliers for our materials.

Audit Sharing
Audit sharing is a resource that I have used and recommend. Third party audits are accepted by the EMA and FDA as long as they are relevant. “Relevant” means the audit and report must relate to a particular supplier facility and to materials made at that facility that are used by the drug or device manufacturer and the report needs to be recent. The IPEA audit report I bought on behalf of a client two years ago covered the essential topics, was well written and told the unvarnished truth, in that it noted that the manufacturer of the relevant excipients did not audit its suppliers. (Not good news.) I expect that other organizations that offer shared audits, such as Rx-360 and others, will also offer reliable audit reports.

The International Pharmaceutical Excipients Council (IPEC)has offered a number of shared audit reports over the past few years. IPEC-Americas has more than 70 members, mostly excipient and raw materials producers and finished drug product manufacturers. IPEA (International Pharmaceutical Excipients Auditing, Inc., a subsidiary of IPEC-Americas) has launched a program to provide IPEA Certification of Conformance with Excipient GMPs and six excipient GMP Conformance Certification Audit Reports are available for $750 each. Seven other recent Audit reports are available for $1,500 each. Some of these reports cover multiple excipients made at a particular facility. The IPEA audits evaluate compliance with the NSF 363/ ANSI American National Standard for Excipient GMP.

Rx-360 is an organization focused on pharmaceutical supply chain security that currently offers shared audit reports (19 at last count), each covering a particular supplier facility and named materials: raw materials, excipients, chromatography resins, APIs. They charge non-members $5,000 for a report and members pay $2,500. They report having a backlog of 378 audit requests, which should result in a large number of useful audit reports. Rx-360 was founded in 2009 by volunteers from the pharmaceutical and biotech industry and their suppliers, with members including 25 drug product manufacturers, 31 suppliers and various associations and auditors. Their web site (www.rx-360.org) is a useful resource for current supply chain issues.

EXCiPACT plans to offer independent third party certification and supply chain assessment of manufacturers, suppliers and distributors of pharmaceutical excipients worldwide. EXCiPACT was founded in 2012 by volunteers from IPEC-Europe, IPEC-Americas, European Fine Chemicals Group (EFCG) and others to provide independent third party certification of manufacturers, suppliers and distributors of pharmaceutical excipients. Certification will be to an ISO 9001 GMP Annex, similar to IPEA excipient GMP certification. IPEC-Europe has around 76 members, mostly excipient and drug manufacturers.

APIC is a European group that offers third party API audit reports. The name refers to the Active Pharmaceutical Ingredients Committee, Sector Group within CEFIC/European Chemical Industry Council. APIC has performed three third party GMP Audits in Germany recently and is likely to do many more in the near future, considering the European Directive to prevent falsified medicines requires onsite audits of API manufacturers and distributors. A copy of an audit report is available for

beiwei5du

zysx01234 发表于 2016-6-4 17:52
第三方审计其实就是中介机构审计，一些老外来中国审计条件不具备就请国内的审计机构人员进行审计，发给审计 ...

确实，其实共享第三方审计对于审计企业和被审计房都是有好处的，节约成本和时间，但是三方（auditee,auditor,customer)必须建立在契约精神上，不知道即使国内采取这种方式的话，是不是后面会搞得水分太多。具体的第三方审计操作流程可以参见http://apic.cefic.org/publications.html，其中涉及到audit questionnaire,audit report template和audit aide memoire确实对于API企业内审非常有用！！！！

beiwei5du

How to share Audits
  
One of the most important tools in supplier qualification is the on-site audit. Although the QP is not obliged to perform the audit him- or herself, the responsibility stays with the QP. A possibility in saving resources is sharing an audit.

For that reason the European QP Association initiated a database comprising shared audits information. QPSHARE is a free of charge database which is intended to help QPs when they want to audit certain suppliers (APIs, Excipients). Currently, almost 300 suppliers are listed in the database, most of them from China and India. Approx. 500 requests for shared audits have been created so far.

To find out more about this exclusive initiative for QP Association members please see the Q&As on QPSHARE.

beiwei5du

Shared Audits: How Can You Find Partners in Order to Share Audit Costs?
  
'Shared audits' are on everyone's lips. The term describes the fact that several firms hold a joint audit of the same supplier. Such a procedure can reduce the costs considerably. Above all pharmaceutical enterprises with a large number of suppliers face a genuine challenge. Here, the costs resulting from the large number of audits are not the only problem.

Some API (active pharmaceutical ingredients) manufacturers have no free capacities due to the large number of enquiries. Now, the pharmaceutical enterprise is in a difficult situation. On the one hand, the audit must be performed in order to be able to furnish the corresponding proof within the framework of the GMP inspection, on the other hand, the enterprise does not get an appointment for performing the audit, since the API manufacturer is already being audited by other companies. Thus, shared audits can reduce the investment of time and money both on the part of the pharmaceutical company and on the part of the API manufacturer. Often, the sheer number of required audits poses a problem. Not every pharmaceutical company can conduct all audits itself and with its own resources. Admittedly, there is the possibility to charge external consultants/service providers with this task. However, in case of a major number of audits, this is certainly not the most budget-friendly solution. Apart from this, the pharmaceutical enterprise has to make sure (e.g. by means of a contractual agreement) that the consultant has not worked for the supplier to be audited, since this situation would confront him with a conflict of interests. Such a conflict of interest renders an audit, and thus the audit report, useless.

The European QP Association has now developed a system enabling QPs to find out quickly and informally if other firms are also interested in a certain API or excipient manufacturer. By this time, the organisation has 1,300 members. Each member has access to a database in which one can see within seconds if and - if so - how many QPs are interested in an audit of a certain supplier. Furthermore, each member can enter further potential suppliers into the database. In this way, the database grows virtually on a daily basis through the organisation's members. The QP Association is not involved itself in the performance of the audits. The organisation merely offers a procedure for establishing the first contact between the firms or the QPs. Then it is up to the QPs involved if e.g. one of the pharmaceutical companies conducts the audit and shares the costs with the others or if a third party is charged with the task.               

Very few programmes available on the market fulfil EMA's (formally known as EMEA) requirements. The EMA requirements on third-party audits can be found here). For APIs, there is currently the APIC Third Party Audit Programme. For excipients, the IPEC/EFCG Audit Programme (EXCIPACT) is soon to be introduced

胜利者

地板

syhorchid

第三方审计，值得提倡。

zysx01234

第三方审计其实就是中介机构审计，一些老外来中国审计条件不具备就请国内的审计机构人员进行审计，发给审计报告。
国内的厂家一般都懒得进行供应商现场审计，这个观念的确比较差劲

zysx01234

beiwei5du 发表于 2016-6-4 18:56
确实，其实共享第三方审计对于审计企业和被审计房都是有好处的，节约成本和时间，但是三方（auditee,audi ...

其实第三方审计还是比较严格，当然也不排除被被审计对象收买的可能，比如送点好处，让审计官把缺陷写的轻描淡写一点。

beiwei5du

zysx01234 发表于 2016-6-4 18:59
其实第三方审计还是比较严格，当然也不排除被被审计对象收买的可能，比如送点好处，让审计官把缺陷写的轻 ...

还有一个困难就是按照流程中有提到审计报告需要被auditee审核，不知道怎么能够客观达到呢？？？官方审计的话权威在，那么靠这种第三方审计的话就只能靠制度约束了。我觉得这种才是法制，俺们天朝是官制。

volador

Supplier Assessment Questionnaire Kit (download)

Rx-360 SUPPLIER ASSESSMENT QUESTIONNAIRE 2014

Webinar: Supplier Assessment Questionnaire Version 2.0 (download)

往事随风12

谢谢分享，学习一下。

18362192280

真的是好东西啊，谢谢

2iso

谢谢分享