Friday, May 24, 2013
About Rx-360 Minimize
  

General FAQs Minimize

Please contact the Rx-360 Consortium Secretariat with any additional questions at rx360info@dbr.com

1.     Who is eligible for membership?

Membership is open to any company whose activities relate to the research, development, or manufacture of pharmaceutical or biotechnology products, including research-based pharmaceutical companies, generic pharmaceutical companies, biotechnology companies, as well as suppliers of ingredients and components of pharmaceutical or biotechnology products. 
 
2.     Who is eligible to be an Rx-360 Observer?
 
The following entities are eligible to become Rx-360 Observers: (i) a governmental unit or quasi-governmental unit, (ii) a trade association or professional association, or (iii) auditors of the quality systems for, and quality of, pharmaceutical or biotechnology products, ingredients or components.
 
3.     How do I become a member or observer?
 
Information on becoming a member or observer is available under the “Membership” tab.
 
4.     My company is frequently audited already by our customers. Why should we invite the Consortium to audit us? 
 
The Consortium audit can be shared with multiple customers reducing the need for general customer audits and thus reducing the overall audit burden on your facility.
 
5.     If I become a member of the Consortium, then can I stop doing audits altogether? 
 
No, there will still be cases where you will need to perform your own audits.  For example, when a raw material has special considerations or characteristics that apply only to your operation or product, then you will need to conduct your own audit on that specific part of the supplier’s process.
 
6.     What are some advantages of the proposed Rx-360 joint audit program as compared with the current auditing process used by individual pharmaceutical firms? 
 
The Rx-360 joint audits will likely be broader and more thorough than typical audits conducted by individual pharmaceutical firms.  Therefore pharmaceutical firms and suppliers can be more confident in the quality system and quality of the products.  Rx-360 joint audits can be shared with multiple pharmaceutical firms thus reducing the number of audits that a supplier must host and that a pharmaceutical firm must conduct itself.  This will reduce the overall audit burden to suppliers and pharmaceutical drug product manufacturers, and these savings can be re-invested in process and quality system improvements.
 
7.     Does ISO certification replace the need to be audited?
 
ISO certification does not replace the need to be audited.  ISO does not deal with individual raw materials / components / excipients / active ingredients, or with manufacturing / distribution / re-labeling / re-packaging / importing practices for raw materials / components / excipients / active ingredients.
 
8.     Is an Rx-360 Consortium audit a substitute for a regulatory inspection?
 
No, the Consortium audits are not a substitute for a regulatory inspection, but they may help you prepare for inspections.
 
9.     Will the Consortium replace the need for regulatory oversight?
 
No, the Consortium does not intend to replace regulatory oversight.  The Consortium intends to build a robust system that meets regulatory expectations and to provide its member companies with the ability to react quickly to new information, implement a more robust and efficient audit process and to advance technologies to support the Consortium’s mission.
 
10. Will regulators accept audits conducted using third party auditors?
 
Both the EMEA and FDA have said publicly that well-trained third party auditors are acceptable.  
 
11. If during a regulatory inspection, the investigator inquires about the auditors’ qualifications and the procedures used to conduct an audit for the Consortium, what should I say? 
 
The Consortium will provide each member with the policies and procedures of the Consortium, including all auditing procedures and records related to the auditors’ qualifications.
 
12. Would the Consortium report an adverse situation discovered during an Rx-360 joint audit to a regulatory body?
 
If an imminently threatening deficiency were exposed that is used in an approved product, the Consortium would work with the sponsor and supplier’s management to report these deficiencies to the appropriate regulatory authority.  If management chose not to adhere to the advice of the Consortium, the Consortium may be legally required to report these deficiencies to protect public health.
 
13. Are third parties authorized to use the Rx-360 logo?
 
No.  Currently Rx-360 does not license the use of the Rx-360 logo to third parties for any reason, and any unauthorized use of the logo by a third party should not be construed as indicating an endorsement by the Rx-360 Consortium.
  

FAQs for Suppliers Concerning the Rx-360 Proposed Joint Audit Program Minimize

Please contact the Rx-360 Consortium Secretariat with any additional questions at rx360info@dbr.com

 

1.     Is this the only quality audit I will receive from a pharmaceutical company?

 We can’t guarantee this is the only audit you will receive. The intent is that Rx-360 member companies will use this audit reducing the number of general audits you receive. There still may be times when an Rx-360 member company feels that it needs to conduct a “for cause” audit due to an issue it has specifically encountered. These types of audits will be handled directly between you, the supplier, and the member company. 
 
 
2.     Is there any cost to me, the supplier?
 
No, there is no cost to have the audit performed at your facility.
 
 
3.     My company charges for performing audits to cover the costs associated with hosting audits, who will pay for this charge?
 
The purpose and value of an Rx-360 audit is that the number of routine individual audits a supplier must host will be reduced. The Consortium has no plans to reimburse suppliers for the costs associated with hosting Rx-360 joint audits.
 
 
4.     Will I have the right to dispute the audit findings and/or refuse to have the audit published?
 
Yes, you will have access to the audit report and the opportunity to discuss any concerns prior to publication. You will not be able to refuse to have the final audit report published.
 
 
5.     What standards will my company be audited to and are those standards made available for review prior to the audit?
 
Rx-360 audit standards will be based largely on government and public standards. You will receive a Pre-Audit Plan that will describe the areas to be covered.
 
 
6.     What Sales/ Marketing advantage does my company have by participating in the audit program?
 
Rx-360 is not intended to provide any sales or marketing advantage to any given supplier. Rx-360 does not approve or certify suppliers. It is up to the supplier whether or not to advertise its participation in the consortium.
 
 
7.     Will I be given an audit rating?
 
You will receive a rating for each audit observation (potentially critical, major or other) but you will not receive an overall Rx-360 audit rating.   It is up to each member company to review the observations, and your responses, to determine audit acceptability.
 
 
8.     Who will be responsible for the corrective action follow-ups?
 
You will be responsible for submitting the corrective actions to Rx-360.
 
 
9.     Can I refuse another pharmaceutical company’s audit request and tell them to use the Rx-360 audit?
 
This will need to be handled between you and your customer. The Rx-360 audit may be available for purchase to Rx-360 members. 
 
 
10. Can one of my competitors see the audit?
 
You will have the ability to deny access to any company you choose. The audits will be managed through the Consortium keeping the strictest level of confidentiality.
 
 
11. Are there consortiums in other sectors that already conduct shared audits?
 
There are other consortiums that use the shared audit report function. For example, one is in the textile industry and another is in the environmental waste sector.
 
  

FAQs for Suppliers Concerning the Proposed Rx-360 Audit Sharing Program Minimize
Please contact the Rx-360 Consortium Secretariat with any additional questions at rx360info@dbr.com
 
1.     How will redacting be done?
Redaction should be accomplished by following the general policies put forth in the redacting policy provided by Rx-360. This policy will be shared with all suppliers and sponsors participating in the pilot program.
 
2.     What if I don't want to share audit information with all companies in the Consortium?
You will have the ability to deny access to any company you choose. The audit information will be managed through the Consortium keeping the strictest level of confidentiality.
 
3.     Can one of my competitors see the audit?
You will have the ability to deny access to any company you choose. The audit information will be managed through the Consortium keeping the strictest level of confidentiality.
 
4.     In what format do I send reports/responses?
Audit reports and responses can be sent to Rx-360 in the original format in which they were written. Further, if sent electronically, the documents can be sent in an MS Word file or PDF file. 
 
5.     Can I “pick and choose” which reports I am willing to share?
To obtain a complete picture of your audit history the Consortium would request all audits be shared but the ultimate decision to share is controlled by you.
 
6.     Will these reports be shared with regulators?
We do not anticipate regulators requesting access to shared audit reports from Rx-360, but in the event of such a request we would notify you.
 
7.     If I agree will this eliminate the need for Consortium companies to audit?
This would not exclude Consortium companies from conducting independent audits to satisfy their company requirements; however, we anticipate some companies using this information to replace or supplement their own audits reducing the overall audit burden on suppliers.
 
8.     What if we disagree with the findings of a specific audit – are we required to share this?
The Consortium would prefer to have access to all audits but you retain the right to not share. Providing both the audit findings and responses allows full transparency to the views of both companies.
 
9.     How will future audits by Consortium companies be handled – will I have to provide these also?
Assuming that this program is successful we would like to continue to have you submit future audits conducted by Consortium members.
 
10. How is confidentiality of the audit information ensured?
Confidentiality of all audit information shared with Rx-360 is covered by confidentiality agreements which suppliers are invited to review and sign as participants in the pilot program. Audit sponsors will also be required to sign a confidentiality agreement.
 
11. Are the standards Rx-360 will use in conducting audits legally enforceable standards?
 
Rx-360 audit standards will be based largely on government and public standards. While the Rx-360 audit standards will be based largely on officially recognized public standards and regulatory guidance documents, the Rx-360 audit standards do not themselves have the force or effect of law.
 
 
12. Will government inspectors use the Rx-360 audit standards during regulatory inspections?
 
It is unlikely that a government regulator would conduct an inspection against the Rx-360 audit standards. As noted, the Rx-360 audit standards will be based largely on officially recognized public standards and regulatory guidance documents; however, the Rx-360 audit standards do not themselves have the force or effect of law.
 
 
13. Would the Consortium or its members share an audit report with government regulators?
 
Typically, the Consortium would direct regulatory agencies to the audited supplier for purposes of requesting copies of audit reports. However, when specifically requested or required by a regulatory authority to disclose an audit report, the Consortium will do so. Moreover, as noted, there may be circumstances in which the Consortium is legally required to report audit findings that could adversely impact public health if not immediately reported to government authorities.
 
 
14. Will regulators accept audits conducted using third party auditors?
 
Both the EMEA and FDA have said publicly that well-trained third party auditors are acceptable.  
 
 
15. Is an Rx-360 Consortium audit a substitute for a regulatory inspection?
 
No, the Consortium audits are not a substitute for a regulatory inspection, but they may help you prepare for inspections.
 
 
16. Will the Consortium replace the need for regulatory oversight?
 
No, the Consortium does not intend to replace regulatory oversight.  The Consortium intends to build a robust system that meets regulatory expectations and to provide its member companies with the ability to react quickly to new information, implement a more robust and efficient audit process and to advance technologies to support the Consortium’s mission.
 
 
17. How does someone suggest that a technological solution should be sponsored by the Consortium to solve an existing problem?
 
Please submit any such suggestions to rx360info@dbr.com.

 
  

 
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