Defining Your GMP Training

Program with a Training Procedure

James L. Vesper

H
FDA and quality auditors aving a standard operating procedure to consider; if your company does have one in
expect pharmaceutical (SOP) that defines your training place, you can use these as a checklist in
manufacturing program is not a specific requirement evaluating it.
companies to have
of the drug CGMP regulations
standard operating
procedures (SOPs)
(21 CFR 211.25). However, a train- SOURCES FOR CURRENT EXPECTATIONS
defining their GMP ing SOP is an expectation of the What specifically should be included in your
training programs, but it agency and quality auditors because GMP training program SOP? Where can you find
is up to each company to it is both feasible and valuable: The leading com- a list of what regulators want to see in such a
determine what should panies in our industry each have one, and it adds document? Unfortunately, there isnt one easy
be included its SOP. Here to the control of each companys operations, place to look: There is no FDA guidance to
are information sources products, and decisions. From a quality and busi- industry on training.
to consider and specific
ness perspective, a procedure that defines and First, look at the GMP regulations that apply to
topics to include when
describes your GMP training activities is a simple your company. They might include the regula-
writing a training
program SOP. yet effective way to communicate and standard- tions of one country or several countries,
ize what is expected. depending on where your products are marketed.
It seems logical, then, to describe what should Youll see words and phrases in FDAs CGMP
be considered in a document defining a GMP requirements on training that will require defini-
training program. If your company does not have tion in your companys procedure, such as train-
a training procedure, you can use these as points ing shall be conducted by qualified individuals,
and on a continuing basis (emphasis added). In
your procedure, you define what those words
mean to your company (consistent with other ex-
pectations mentioned below).
Next, look for other applicable regulations that re-
quire training. For example, FDAs Electronic
Records and Signatures regulation (21 CFR 11)
requires that companies using electronic signa-
tures provide training to their personnel on the
regulation and associated procedures.
Review recent warning letters and 483s issued by
the agency. Warning letters, available online
(www.fda.gov), and observations of noncom-
pliance show what other companies lack.
Consider those issues as you prepare a procedure.
Pay special attention to the warning letters
because they have been reviewed more thor-
oughly. The Gold Sheet listed training as an
item in 10 of the 71 warning letters issued in
PHOTODISC, INC.

1999 (1).
Read through the training-related comments in the
preamble to the 1979 version of the GMPs

28 BioPharm NOVEMBER 2000

(items 106 to 111). They give FDAs original Who is to be trained. In this part of your
intent about what the agency expects in a GMP procedure, identify the general audiences for
training program and why. training. This includes operations, maintenance,
Look at the GMP regulations of other countries lab, and technical staff; it also includes manage-
and regions Canada and the European Union, ment (read 21 CFR 211.25b), contract, tem-
for example even if your company is not re- porary, and consulting personnel. As I work with
quired to comply with them. Youll find that drug and biopharmaceutical managers, I en-
those perspectives can help give you a richer un- courage them to give some GMP training to
derstanding of what training should include. For everyone. Because GMPs are product-critical,
example, in the Canadian GMPs, a strong everyone in an organization needs to have some
rationale for training includes the observation that GMP literacy. As you consider audiences for
without the proper staff with the right attitude training, do not forget senior- and executive-level
and the right training, it is almost impossible to management who make GMP-related decisions.
fabricate, package, label, test, or store good
quality drugs (2).
Read through a classic article on GMP training Give some GMP
such as A Systematic Approach to GMP Train- training to everyone;
ing, by Ron Tetzlaff, formerly with FDA (3).
Some of the terms used are slightly different from that includes
what training professionals use today, but the Temporary (temps) and contract personnel
contract, temporary,
article describes clearly what your program present a particular training challenge. Organiza-
should include. tions like using them for flexibility and to keep and consulting
head counts low. That doesnt excuse a company
POINTS TO INCLUDE IN A TRAINING SOP personnel. Everyone
from the GMP SOP training requirements. One
What should be included in your companys company that made extensive use of temps was in an organization
training SOP? Here are some points to consider. told by local FDA investigators that FDA would
The information sources listed above provide review temp and contractor training in future
needs to have some
additional details that you may include. inspections. GMP literacy.
Scope of the procedure. Define what personnel or When training is conducted. GMPs require that
sites are covered by the training procedure. For training be ongoing. Most companies conduct
example, the procedure might have a corporate- formal GMP training or reinforcement training at
wide scope, or it might affect only one site or least annually; some do it twice a year; a few do
business unit. it quarterly. Training on specific GMP-related
Types of training covered by the procedure. GMPs skills (such as conducting root-cause analysis)
call for training personnel in the application and and on new, revised, and unchanged procedures
interpretation of GMP regulations and in the should be considered here as well. (In an
tasks they perform. Some companies have one upcoming article, I will discuss frequency of
procedure that covers both types of training; procedure training.) Be realistic as you set train-
others have two or more SOPs. ing intervals so you can actually accomplish what
Responsibilities for the training program. The SOP is defined.
should define what organizational unit(s) is (are) Quality unit involvement. The quality control
responsible for oversight of training efforts, (QC) or quality assurance (QA) unit should
design and delivery of the training events, and approve various elements of your training
auditing to be sure a training program is working. program. QA review and approval of GMP-
Responsibilities are frequently split among units. related training courses are particularly
For example, some companies include GMP important. QA approval should indicate that the
training as part of the quality assurance (QA) unit courses are complete and accurate, covering
and SOP and skill training as part of the indi- topics and using examples that are relevant and
vidual operations area. Other companies include meaningful to the learners. The quality unit also
GMP and skills training as part of the human should review and approve GMP-training cur-
resources (HR) organization. Use caution; some ricula for job functions or positions.
HR groups are not sensitive enough to the special Although the points listed above are con-
compliance issues that are part of GMP training: sistently adopted as industry practice, the
It is not just another soft skill topic, a nice-to- approval of SOP training varies considerably. It
know course, or one that a generalist can teach. is easy to say that QA should review the training
outline for each course (for each procedure), but
BioPharm NOVEMBER 2000 29
GMP Training what real value does QA add if it is asked to example, the expiration date plus one year of the
approve 1,0001,500 SOP courses? What does last lot made by people who were trained using
Relevant articles from the
the typical QA representative know about teach- that material), but a more practical solution is to
BioPharm Archives:
ing a cleaning procedure for a ribbon blender? In keep the materials (and approvals) of the course
Good Manufacturing some situations, QA approval is just a rubber currently being used along with the version
Practices Training, stamp, an act that looks good but gives a false previous to it.
C.M. Orelli, 1(4), April 1988, sense of assurance. An alternative is for QA to Qualification of instructors. GMPs require that
p. 38. approve the templates or standard outlines for instructors be qualified; in your training SOP,
Training People to Take training (to be discussed in a future article) and you have a chance to define what that means.
Responsibility for Quality, place a high emphasis on the review and approval One way is to establish minimum instructor
D.E. Nellis, 1(10), October of instructor qualifications. requirements, such as successful completion of
1988, p. 24. Learning plans and curricula. A learning plan or basic and advanced GMP training, and communi-
Creative Ideas for GMP curriculum for a position lists the instructions that cation skills such as successful completion of a
Training, C.M. Orelli, 4(9), person needs and the recommended sequence and presentation skills workshop. Then for each
September 1991, p. 42. time points for each event. Some companies have course, define what additional knowledge or
integrated learning plans that cover more than skills the instructor needs. For example, an
Excellent Training Begins
with Training that Counts,
GMP topics, such as worker health and safety, instructor of a course in basic GMP and quality
B.K. Immel, 10(1), January organizational development, and so on. The list auditing should have experience as an auditor.
1997, p. 24. of procedures, protocols, and methods used is Sometimes it is difficult to find good trainers
also part of a persons learning plan. Learning who also have solid experience or knowledge in a
The Essence of Training, Part
plans should be developed for everyone in a particular technical area. For example, Ive seen
1, B.K. Immel, 11(5), May
GMP organization, including all levels of experts in computer validation who are com-
1998, p. 90.
management. The quality unit should review and petent in developing and executing protocols but
The Essence of Training, Part approve the learning plan for each job function. are noticeably uncomfortable leading a class.
2: The Plays the Thing, B.K. Learning plans become the specifications for That is an excellent opportunity for co-teaching:
Immel, 11(6), June 1998, training. Periodically, they need to be compared an experienced instructor helping to lead the
p. 62.
against the training records for each person to formal sections of the course and the expert
GMP Compliance from a ensure that the prescribed training is taking place. serving as a resource to relate experiences and
Production Managers Point of Development process. Many companies use a answer questions. If a co-teaching approach is
View, M. Pemberton, 11(8), standardized approach to developing training used, both people should be qualified as a team,
August 1998, p. 34. courses and events, which is called instructional and that should be provided for in your training
Improving Your Training systems design (ISD). The ISD model includes SOP. The quality unit should review and approve
Program, B.K. Immel, 12(8), analysis, design, development, implementation, potential instructors.
August 1999, p. 31. and evaluation (sometimes referred to as Scheduling and administration of training events are
ADDIE) (4). To ensure course integrity and time-consuming tasks essential to the success of a
consistency, some companies require that such an training department. Different approaches used
approach be used. by companies include an assignment approach
Maintenance of training materials. FDA and regu- (you will attend on this date and time) or
latory agency expectations regarding GMP and providing learners (or their supervisors) with a
regulatory compliance change over time. An SOP set of dates they can select from. Some training
should include a provision for periodic review management systems and networked meeting
and updating of training courses and events. All scheduling tools help with this task. The
changes should be approved by the quality unit method(s) used and responsibilities should be
before being implemented. The plan also should defined in the SOP.
consider the impact of new content on those who Documentation of participation in training events.
have already taken the course; alternatives to Several elements figure into documenting when
retaking the full course may be adequate. someone completes a training course. For leader-
Retention of training materials. An official copy led sessions, minimum information is a sign-in
of instructional materials (such as course outline, sheet with the persons name, signature, name
worksheets, and instructors notes) should be and number of the course, date of the session, and
retained. Your procedure should define where the instructors name and signature. The partici-
such materials are filed. Regulatory investigators pants signature attests to his or her attending the
rarely ask to see course outlines; such materials complete session; the instructors signature
are more valuable as a record of what was attests that the program was given and that the
actually taught. In deciding how long to keep people listed did attend.
them, you could do a complex calculation (for
30 BioPharm NOVEMBER 2000
 Many companies enter the attendance list into Program evaluation. Virtually all drug compa-
a training management system (for example, nies use participant feedback forms to collect
Plateau, from Plateau Systems, Ltd., Fairfax, VA; subjective information from the attendees of at
or Training Tracker, Interpharm Press, Engel- least some of their training events. Your SOP
wood, CO). Your SOP should define how this is would state when feedback forms are appropriate
done, including verifying the transcription, and how the data are to be collected and sum-
retaining the sign-in sheets, and controlling the marized for the instructor and various members
system. of management.
Reports to management. Management at all lev-
els should be kept informed about training activi-
Your training ties. Summary data can include the number of
procedure also people attending programs, percentages of those
who have completed particular courses, people
should consider who are significantly behind in meeting their
keeping records on Some e-learning courseware automatically training plans, and assessment scores. If people
feeds completion and testing information into a are not getting trained in a timely way, manage-
temporary and training management system. If such software is ment may find that production demands are
used, it also should be described in the procedure. impinging on time available for training.
contract personnel
If testing scores or passfail assessments are
who must meet GMP collected, it is useful to include them in the train- KEEP IT PRACTICAL
ing management system. Your training procedure needs to be complete,
training but dont burden it with unnecessary and imprac-
Attendance in outside training and educational
expectations. events (such as conferences and technical meet- tical details. You want the procedure to define
ings) also should be documented because it and standardize your GMP-related training activi-
contributes to a persons education, training, and ties so you can enable your personnel at all
experience. Copies of certificates, continuing levels to make decisions and take actions that
educational units (CEUs), and program outlines contribute to products that are safe, identified, of
or mailers are useful records to retain. Some the correct strength and purity, and of high
electronic training management systems have quality.
provisions for documenting outside events.
Your procedure should define where such REFERENCES
(1) FDA Drug CGMP Warning Letters from FY 1999,
information is kept (preferably not as part of the The Gold Sheet 34(3), 916 (2000).
persons confidential personnel files) and how (2) Good Manufacturing Practices, 1998 Edition,
long it should be retained (typically several years Health Canada, Personnel, C.02.006 rationale
(Health Canada, Ottawa, Ontario, 1998).
beyond the last date of the individuals employ- (3) R. Tetzlaff, A Systematic Approach to GMP
ment). Your training procedure also should Training, Pharmaceutical Technology 6(11), 4251
consider keeping records on temporary and (1982).
(4) J.L.Vesper, Training for the Healthcare Manu-
contract personnel who must meet GMP training facturing Industries (Interpharm Press, Engelwood,
expectations. Training management systems CO, 1993). BP
often are tied into a companys personnel and
Corresponding author James Vesper is executive
payroll database, which does not include tem-
producer of pharma programs for Learnwright, LLC, and
porary or contract people. also founder and president of LearningPlus, Inc., 1140
Learner assessments. Your companys use of Highland Avenue, Rochester, NY 14620, 716.442.0170,
testing or assessment is described in this part of fax 716.442.0177, jvesper@learningplus.com,
the training procedure, including the types of www.learningplus.com.
assessment used (such as pen and paper, orals,
computer-based, or performance-based). A
particularly important element is determining
what constitutes passing and what happens when
an employee does not pass a test. You do not
want to create the awkward situation of a person
independently performing a GMP task on which
he or she has been assessed and failed. Consider-
ation also must be given to other legal issues of
testing on the job if it in any way affects a
persons salary or position.
32 BioPharm NOVEMBER 2000