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CPGP Cert Insert
CPGP Cert Insert
CPGP
GOOD MANUFACTURING
PRACTICES PROFESSIONAL
Examination
Each certification candidate
is required to pass an
examination that consists of
multiple-choice questions that
measure comprehension of
the body of knowledge.
Education
CPGP and/or Experience
Computer Delivered – The CPGP You must have five years of on-the-
examination is a one-part, 165 job experience in one or more of the
multiple-choice question, four-and- areas of the Certified Pharmaceutical
a-half-hour exam and is offered in GMP Professional Body of Knowledge.
English only. One hundred and A minimum of three years of this
fifty questions are scored and 15 experience must be in a decision-making
are unscored. position. “Decision-making” is defined
as the authority to define, execute, or
Paper and Pencil – The CPGP control projects/processes and to be
examination is a one-part, 150 responsible for the outcome. This may
multiple-choice question, four-hour or may not include management or
exam and is offered in English only. supervisory positions. There are no
education waivers for this exam.
2. Reagents, solutions,
and standards identification
Determine whether reagents,
solutions, and standards are
identified and labeled in
accordance with requirements,
including opened-on, expiry,
(validated) use-by, or recertify-by
dates. (Apply)
3. Storage requirements
Describe and use procedures to
store samples, reagents, solutions,
and standards in appropriate
environmental conditions (e.g.,
temperature, humidity, light
exposure, absence of oxygen) to
maintain the material’s characteristics
for testing. (Apply)
G. Stability Programs
E. Laboratory Record-keeping 1. Release tests vs.
and Data Requirements stability-indicating tests
1. Record-keeping requirements Define and distinguish between
Identify and review record-keeping these two types of tests. (Apply)
requirements for data acquisition
systems to ensure data integrity. 2. Stability test data
(Apply) Review stability data against
specifications and identify trends
2. Record review that can establish, support,
Review laboratory records to or challenge an expiry date.
detect errors or falsification, to (Evaluate)
prevent loss of data and ensure
data integrity. (Apply) 3. Stability-point failure
Identify the stability-point failure
3. Certificates of analysis (COAs) of a product or material, and
Review COAs to ensure they are evaluate the implications for
complete, internally reviewed, and regulatory compliance. (Evaluate)
appropriately retained. (Apply)
H. Reserve Samples and Retains
Describe the various regulatory
requirements for retains and reserve
samples. (Apply)
2. Storage
F. Contamination and
Describe and apply requirements for
Cross-contamination segregation and secure storage of
1. Sources these materials. (Apply)
Identify potential sources for
these events. (Apply)
In addition to content specifics, the subtext for each topic in this BoK also
indicates the intended complexity level of the test questions for that topic.
These levels are based on “Levels of Cognition” (from Bloom’s Taxonomy—
Revised, 2001) and are presented below in rank order, from least complex
to most complex.
• Applications
• Reference materials
• ASQ sections
• International contacts
• Endorsements
Item B1638