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U.S. Department of Health and Human Services

Drugs

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Pharmaceutical Inspectorate (PI) Frequently Asked Questions

Originally issued September 2003; revised January 2004

  1. What are the differences between the Pharmaceutical Inspectorate (PI) and evolving cadre of the Product Specialists? 
    The Pharmaceutical Inspectorate will be a group of Field Investigators who have specialized experience and specific training in evaluating pharmaceutical manufacturing. The "Specialists" are staff members in the Centers and Field who are experts on the science associated with complex products and technologies. "Specialists" may accompany Investigators during an inspection or will otherwise be available to provide scientific support during the course of an investigation. For more information on the "Specialist" program, refer to the "Potential Use of Specialists -- An Emerging Team Approach"  [http://www.fda.gov/cder/gmp/Specialist-Diagram.pdf] and the progress report on "Specialists on Inspection Teams" [http://www.fda.gov/cder/gmp/productspecialists.htm].
  2. Is the PI the same as Team Biologics? 
    No. Team biologics is small group of investigators (13 total) managed by the Office of Regulatory Affairs headquarters staff. The PI is a group of individuals that will be managed by their district managers. The PI is analogous to the individuals who are certified to do MQSA or Seafood HACCP inspections.
  3. What are the differences between a Drug Specialist and the PI? 
    A Drug Specialist is defined by his/her PD. The PI has completed a predetermined curriculum and is audited to achieve a Level III certification. Many of our current Drug Specialists have completed some of the course work and may be considered to be a member of the PI. However, they would still need to apply and go through the process of review, complete any additional course work required to be certified at level III before becoming a member of the PI.
  4. Is the PI a group of individuals that is separate from the GS-13 Drug Specialists currently in the field? 
    Yes, they are separate groups. However, all drug specialists are eligible for nomination by their supervisors to become Level III drug certified and members of the PI.
  5. Once the PI is fully established, what type of inspections will the remaining GS-13 and GS-12 Drug Specialists conduct? 
    The drug inspection program is quite large. The statute requires us to inspect drug firms every two years and we have had difficulties meeting that goal in recent years. As our inspections become more risk based, we will be able to triage our workload to help meet our biannual goal. This work cannot be accomplished by the PI alone.
  6. What are the difference between the PI and a National Expert? 
    The National Expert’s responsibilities and duties are defined by his/her position description (PD). The PI has completed a predetermined curriculum and is audited to achieve a Level III certification. The National Expert may also receive a Level III Drug certification and become a member of the PI.
  7. Is the District Pharmaceutical Specialist position being eliminated
    No. The Specialist positions remain the same.
  8. Who will the members of the PI report to? 
    Members of the PI report directly to the management structure currently in place in the ORA District Offices.
  9. Who will give assignments and establish the work plan for the PI? 
    Members of the PI will receive assignments from the District Office Management based on the work plan developed by ORA and the Centers.
  10. Will the PI be required to travel both domestically and to foreign countries? 
    Yes, just as all journey level and above investigators are required to do now. Based on the inventory of drug facilities that need to be inspected, members of the PI will conduct both foreign and domestic inspections. The number of inspections conducted outside of the Investigator's District, including foreign inspections, is yet to be determined.
  11. What is the actual amount of travel? 
    The amount of travel is dependent on the overall inventory of firms that need to be inspected and the location of those firms, as well as the location of the members of the PI. It is difficult to say the percentage of travel that would be required for any one individual of the PI. Nevertheless, we anticipate the number of members of the PI and their geographic dispersal will be much like the proportionate distribution of the current drug workforce, inferring that there shouldn't be a significant change in travel requirements domestically. In addition, foreign inspections are ever increasing and assignments to those inspections will be made under the MOU as negotiated between ORA and NTEU.
  12. Will the PI be traveling like Team Biologics? 
    No. We do not anticipate the PI to travel in the same manner as Team Biologics. District managers will make assignments based on the inventory of firms in their districts. However, if a district lacks PI expertise, the district will ask for assistance from other districts.
  13. What will be involved with the Level III drug certification program? 
    Developed similar to the Level II Drug Certification program, the Level III Drug Certification program will include a variety of training modules on the science, policy, and standards related to FDA's regulation of the pharmaceutical manufacturing process and how evaluations are performed during an inspection. Requirements for the Level III Drug Certification will be developed by a Level III Drug Investigator Certification Board. This Board was established in the Fall of 2003.
  14. Who will be eligible to be in the PI? 
    Investigators who have at least 3 years of experience in inspecting pharmaceutical manufacturing facilities including regulation/inspection of drug facilities, and are certified as Level II Drug Investigators (as defined by the ORA certification program) may seek nomination by their district managers to enter the Level III drug certification program. Once they have successfully completed the Level III drug certification program, they will become members of the Pharmaceutical Inspectorate.
  15. Are all Drug GS-13s required to undergo the process of becoming a member of the PI? 
    No. This is strictly a voluntary program.
  16. When will the PI be established and when will the Level II and III Drug Certification programs be established? 
    We have already put out a call to seek volunteers to both the Level II and the Level III Drug Certification programs. ORA’s DHRD with CDER’s Training Staff is initiating course development. Once individuals have successfully completed their Level III Certification and have been selected by the Level III Drug Certification Board, they will become members of the PI.
  17. How will the nomination process be conducted? 
    ORA's Division of Human Resource Development (DHRD) will issue calls for volunteers for the Level III Drug Certification. The Center, District, or Branch manager will create a prioritized list of all volunteer candidates endorsed to be Level III certified and forward that list to DHRD. The Level III Drug Investigator Certification Board will select all candidates for Level III (Pharmaceutical Inspectorate). The Level III Drug Investigator Certification Board will notify those candidates selected for Level III (PI) upon the Board’s approval of that candidate’s acceptance into the program.
  18. Will the PI include analysts, compliance officers, or supervisors? 
    The PI will include any interested candidate that can fulfill the requirements of the Level III drug certification and maintain the requirements for this certification.
  19. Who makes the final selection of an individual to be a part of the PI? 
    The Level III Drug Investigator Certification Board, consisting of members from CDER, CVM, and ORA, will review nominee packages for Level III certification and membership in the PI and will select applicants based on clearly defined requirements.
  20. Who is on the Level II and III Certification Board and how were they selected?
    The boards are made up of training experts and national experts in the certification area, managers who are very familiar with the program, and center experts in compliance or pharmaceutical sciences. Members have been selected for their experience and expertise in their specialty areas. Selections are made jointly by DHRD, which manages the program, the Field Drug Committee, in the case of the drug certification program, and senior managers at CDER and CVM. The board members do not have to be certified. However, as the program grows, it is likely some members may be members of the PI.
  21. Who will pay for the training and certification requirements? 
    The Center for Drug Evaluation and Research will supplement ORA's funding of the training required for Level III drug certification and membership in the PI. In addition, CDER will assist in funding so that the PI is able to maintain their Level III drug certification.
  22. How many people will be in the PI and how is this number determined? 
    The number of Investigators that will be in the PI will be determined by the inventory of the drug facilities that need to be inspected. This is based on the work plan developed by ORA and the Center. It is anticipated that the initial group will number about 10 to 15.
  23. Will each district/region be expected to have staff dedicated to the PI? 
    The location of the members of the PI will be based on the location of the drug facilities that need to be inspected as determined by the work plan developed by ORA and the Center.
  24. What types of facilities will the PI inspect and what types of inspections will they perform? 
    The PI will focus almost exclusively on inspecting pharmaceutical manufacturing facilities that use complex manufacturing technologies. The PI will be trained to conduct the more complicated and highly technical inspections. As with all of our work, if an emergency or significant follow up investigation or inspection is required for any reason, any CSO, including a member of the PI could be called upon to perform the work.
  25. Must you be a member of the PI to conduct inspections of drug facilities? 
    No. However, as the program evolves, the PI will be expected to perform the more complex and high-risk pharmaceutical manufacturing inspections, especially where such inspections involve new technologies where the PI has received training. A current example would be where a firm is bringing Process Analytical Technology into their facility.
  26. Will the PI also perform inspections on other types of facilities (e.g., food and device)? 
    It is expected that a majority of the PI time will be spent on pharmaceutical inspections. The District Offices will still have the ability to make other assignments, as necessary.
  27. Will the PI be expected to be experts in drug manufacturing technologies or simply be knowledgeable of existing technologies as they relate to performing inspections? 
    The PI will be expected to have a basic understanding of all complex and emerging technologies in manufacturing science and be able to apply their understanding of these technologies to an inspection. If an expert in a specific technology is needed, a "Specialist" should be consulted.
  28. What incentives are there for individuals to be a part of the PI? 
    The Level III Drug Certification will provide PI with the opportunity to be the recognized experts in the latest manufacturing technologies. Members of the PI will have the first opportunity in ORA to be trained on these manufacturing technologies.
  29. Is the PI linked to promotion potential? 
    Not at this time.
  30. Who do I contact for further information regarding the Pharmaceutical Inspectorate? 
    You may contact Khyati Roberts, Project Manager for the Pharmaceutical Inspectorate Working Group via email at robertsk@cder.fda.gov.

 

Date Created: April 13, 2004