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ISPE-PCC Code of Ethics and Standards of Professional Conduct

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The following are the code of ethics and standards of professional conduct standards to be maintained, supported, and defended by those individuals who are candidates for or holders of credentials as conferred by the ISPE Professional Certification Commission (ISPE-PCC). The purpose of this code and standards is to promote professional good conduct and industry best practice.

Periodically the ISPE-PCC may make amendments to this code and standards. Certificants and candidates are obliged to familiarize themselves with and adopt the amendments as they are published.

Preamble

The pharmaceutical industry and the products it produces have a vital and direct impact on the quality of life for all people globally. High ethical standards are critical to maintaining the consumer’s trust.

Accordingly, pharmaceutical industry professionals involved in the development, manufacturing, and distribution of these products must exhibit the highest standards of honesty, integrity and competency and sustain the prestige, honor and reputation of the pharmaceutical profession as demonstrated in accordance with standards of professional behavior. All ISPE-PCC credential holders must abide by the ISPE-PCC Code of Ethics and Standards of Professional Conduct and are encouraged to inform their employer of these responsibilities. Violations may result in disciplinary actions by the ISPE-PCC. These actions can include revocation of a credential, denial of candidacy for ISPE-PCC conferred credentials, and the right to use credential designations.

The Code of Ethics

The Code of Ethics is a set of principles that defines the professional conduct ISPE-PCC expects from its certificants and candidates. The Code of Ethics works together with the Standards of Professional Conduct which provides guidance for certificants and candidates regarding ethical and fair professional practices. The Certificants and candidates shall:

  1. Hold paramount the health, welfare and safety of the public, customers, colleagues and employers and protect the environment and property in the performance of the certificants professional duties.
  2. Act with objectivity, competence, and in an ethical manner with colleagues in the pharmaceutical and related industries, the public, employers, clients and prospective clients worldwide.
  3. Maintain all relationships with the highest standards of integrity and honesty.
  4. Take reasonable steps to ensure the privacy and safekeeping of confidential and proprietary information concerning the business affairs and technical processes of any former or present employer or client or public body for which they serve.
  5. Refrain from receiving or offering gratuities or inducements that may compromise professional standards or independent judgment.

Standards of Professional Conduct

  1. Comply with applicable regulations, laws and industry codes and standards governing professional practice in the country/state/province where the certificants practice their profession.
  2. Maintain and assure responsibility and accountability for personal competence and adequate knowledge based upon the professional standards of his/her respective field.
  3. Undertake work assignments only when qualified by experience, education and training in the specific science and technology areas involved and obtain appropriate advice from professionals in those areas where own range of ability is exceeded.
  4. Apply high standards of skill, knowledge and care.
  5. Respect the capabilities of other professionally qualified individuals and strives for effective results through consultation and collaboration.
  6. Provide accurate and honest information pertaining to all aspects of the credentialing program, including but not limited to; eligibility applications, assessment applications and related materials, assessments content, continuing certification requirements and recertification applications.
  7. Avoid conflicts of interest or an appearance of impropriety.
  8. Accept and maintain responsibility to make fair and full disclosure of known or potential conflicts of interest that may compromise legitimate interests of clients, prospective clients, employers, or the quality of services being provided.
  9. Respect the intellectual property developed or owned by others.
  10. Refrain from engaging in professional misconduct.
  11. Use reasonable care and judgment, maintain objectivity, and render the highest quality services possible.
  12. Avoid misleading advertising regarding the unauthorized use of ISPE-PCC owned logos, certification seals, and other distinguishing graphics or marks representing the credentials or credentialing programs. The CPIP certificate, seal, and CPIP acronym are owned by the ISPE-PCC. The CPIP certificate/seal must be rendered to the ISPE-PCC upon request from the ISPE-PCC. Use of the CPIP acronym will cease as directed by the ISPE-PCC.
  13. Make claims regarding the CPIP certification scheme only with respect to the scope for which certification has been granted. Do not use the certification in such a manner as to bring the ISPE-PCC into dispute, and refrain from making any statement regarding the certification which the ISPE-PCC may consider misleading or unauthorized.
  14. The ISPE-PCC may investigate and/or sanction certificants or candidates for professional misconduct or failure to adhere to the ISPE-PCC Code of Ethics or Standard of Professional Conduct.
  15. Discontinue the use of all claims to certification that contains any reference to the ISPE-PCC or certification upon the certification being suspended or revoked.

Violations of the Code and/or Standards

The ISPE-PCC may investigate and/or sanction certificants or candidates for professional misconduct or failure to adhere to the ISPE-PCC Code of Ethics or Standards of Professional Conduct. Sanctions may include revocation of a credential, denial of candidacy for ISPE-PCC conferred credentials, and/or the right to use credential designations.

CPIP certified professionals are expected to conduct themselves in a highly ethical manner. The ISPE-PCC recognizes its responsibility to maintain the integrity of the certification program. For the sake of protecting the integrity of the credential, the ISPE-PCC accepts that action may need to be taken against a certificant upon receipt, investigation, and finding of violation(s) of ethics and/or the Standards of Professional Conduct “Standards”.

This procedure describes the steps to be taken for filing complaints. By publishing this procedure, the ISPE-PCC does not expect, invite, solicit or encourage complaints. The use of these procedures is for the sole purpose of protecting the reputation of the certification program, the profession, and assuring a fair investigation of complaints. All complaints, therefore, must stipulate an alleged violation of the published ethics and/or Standards.

Complaint:

  1. Complaints will be accepted only from those who claim to be harmed by the alleged behavior.
  2. All complaints must be in writing and signed by the complainant(s) and only information submitted in writing and signed will be considered.
  3. Complaints and supporting evidence must show a violation of the ethics and/or Standards.
  4. At a minimum, the complaint should specify the respondent, the alleged inappropriate behavior referencing the specific section of the ethics and/or Standards allegedly violated, the standing of the complainant and any corroborating evidence.

Sam DeMarco, CPIP, President Compliance Team Inc, United States

"I believe that the credential has made me more confident and I feel that my clients engage me in more philosophical discussions on pharmaceutical industry subject matter. I get the sense that my clients 'listen' to me in a more serious 'in tune' way."

Marc Fleischman, CPIP, Facility and Verification Engineer, Genzyme, a Sanofi Company

"I chose to pursue the CPIP certification as a way to learn new phases of the industry and to codify my existing knowledge. As I prepared and studied for the exam, I was challenged to develop a broader understanding of many industry concepts that I had not been routinely exposed to. The experience has left me with a deep understanding of GMP regulation and broad industry knowledge across the entire bio/pharm lifecycle."