Friday, October 31, 2014
Becoming a 3rd Party Auditor Minimize

 

One of the objectives of Rx-360 is to conduct joint audits of suppliers.  Therefore, we are looking for auditing firms interested in conducting audits on behalf of Rx-360.  All individuals conducting audits on behalf of Rx-360 must meet the minimum requirements specified below. 

To be considered, each provider of auditing services must first complete an on-line registration form at: 

https://www.research.net/s/BZTC3H7

 

Registration with Rx-360 does not guarantee that you will be awarded a contract to conduct any audits. The actual selection of auditors for Rx-360 audits will be based on a number of factors, including auditing experience and estimated costs. 

 

Minimum Requirements for Rx-360 Auditors

Note:   Listed below are minimum requirements for Rx-360 auditors.

 

EDUCATION

Need a Bachelor’s Degree in a science from an accredited university (a minimum of three years), or demonstrated relevant work experience that provides equivalent knowledge.
PROFESSIONAL EXPERIENCE A minimum of five years of GMP operational pharmaceutical experience.  Operational experience includes those skills and competencies gained while working within a pharmaceutical GMP environment.
REGULATORY KNOWLEDGE Must be knowledgeable about pertinent regulatory and best-practices requirements (e.g. ICH Q7 for APIs, CFRs for USA, IPEC guidelines for excipients).

AUDITOR TRAINING

A quality systems approach that includes training and refresher training of auditors is expected for auditors associated with a provider of auditing services.

Note: Good communication and interpersonal skills are a “must” and are included in this category.

AUDIT EXPERIENCE

Need involvement in at least five audits of the relevant supplier/audit type, including leadership of at least one relevant audit. [See also the maintenance requirement (i.e., at least three audits of the relevant supplier/audit type in the last 12 months)].

Note: Professional experience may impact the amount of audit experience required.
ACCREDITATION/
CERTIFICATION

Auditors must be accredited/certified by a program recognized by Rx-360 e.g., ASQ, ISO17020, IRCA, or APIC.

MAINTENANCE OF
QUALIFICATION
The auditor must be up-to-date on Good Manufacturing Practices (GMPs) and currently performing audits (at least three audits of the relevant supplier/audit type in the last 12 months).
RECORDS OF
QUALIFICATION
A formal recordkeeping system must be maintained of auditors’ qualifications.  The system should include information concerning each auditor’s areas of expertise.
LANGUAGE The auditor must be able to communicate with Rx-360 in written and spoken English.  In addition, the auditor should be able to communicate effectively (e.g., via planned use of interpreters internal to auditee or contracted as necessary) and demonstrate sensitivity to or experience with the local culture.

 

 

  For providers of auditing services, each auditor used in an Rx-360 audit must meet these requirements. 

The detailed “selection and qualification process” is described in the Rx-360 QMS.


All auditors must sign the Rx-360 Code of Ethics for Auditors prior to being eligible to perform Rx-360 audits. 

  

 

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