- 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].
- 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.
- 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.
- 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.
- 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.
- 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.
- Is the District Pharmaceutical Specialist position being
eliminated?
No. The Specialist positions remain the same.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Are all Drug GS
-13s required to undergo the
process of becoming a member of the PI?
No. This is strictly a voluntary program.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Is the PI linked to promotion potential?
Not at this time.
- 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.