GDP/Data Integrity
What is GDP ?
Good documentation practices
What is the main source of contamination:
a) Equipment
b) Raw materials
c) Human
d) Ghosts
A document used in production facilities to guide the production of a product is called:
a) Form
b) Batch record
c) Protocol
d) SOP
b) Batch Record
What is PER?
Positron-emmiting radiopharmaceutical
Laboratory notebooks are :
a) a chronological log of everything one does in a lab.
b) filled out by analysts.
c) used to identify materials.
d) trace movement of a sample.
a) a chronological log of everything one does in a lab.
Raw data records should be
a) Direct, prompt, accurate, accountable, legible, traceable, original and complete.
b) Prompt, adaptable, accountable, limited, traceable.
c) Consistent, traceable, official, signed, simple.
d) Direct, prompt, accurate, accountable, legible, traceable and sufficient.
a) Direct, prompt, accurate, accountable, legible, traceable, original and complete.
What are the two types of sterile testing methods used at CPDC ?
Sterility by Direct Inoculation and Sterility by Membrane filtration.
Following PER manufacturing processes are subject to GMP:
a) Reactor / Cyclotron production
b) Synthesis, Purification
c) Dispensing
d) B and C
e) All of the above
What is the guidance doucment used for PER in US?
FDA CFR Part 212
What documentation does a laboratory have to have in place to be considered qualified to run a test method for raw materials (drug substances and excipients) in order to satisfy Health Canada Regulations?
a) Summary of the analytical method validation
b) An assessment of the results and comparison to the acceptance criteria
c) Conclusion as to the acceptability of the data
d) All of the Above
e) None of the Above
d) All of the above
What is the difference between records and documents?
Documents are to be read and studied only eg. SOP, protocols
Records are filled out contemporaneously to provide evidence that something occurred by following GDP
How is finished drug product manufactured aseptically at CPDC?
a) Terminal sterilization
b) Manual Aseptic process (Sterile filtration)
c) All of the above
d) None of the above
Manufacturing Control during radiopharmaceutical manufacturing is not required for :
a) Proper labeling in order to prevent mix-ups
b) Validated cleaning and sterility procedures as most of the critical testing are done retrospectively
c) The design of the production methodology that prevents cross-contamination.
d) None of the above
d) None of the above
In the context of GMP, what is SISPQ?
Strength
Identity
Safety
Purity
Quality
During routine manufacturing, RNP testing is required -
a) Annually
b) For each batch
c) Every day
d) All of the above
a) Annually
What is the difference between reviewed by and verified by?
Reviewed by means documentation needs to be checked for any errors.
Verified by means that action needs to physically checked as described.
What is the difference between Grade A and Grade C environment?
Grade A is Class 100, with maximum permitted number of particles equal to or above 3500 at rest and in operation.
Grade C is Class 10000, M5.5, ISO 7 with at rest particle count of 350000 and in operation count of 3500000.
FDA 21 CFR part 210,211 is applicable to which isotopes manufactured at CPDC?
I-131, Lu-177, Ac-225 / In-111
List 5 Quality Systems that can be audited by regulatory bodies.
Equipment
Personnel/Training
Raw materials
Manufacturing Controls
Quality Control
Which regulatory agency was the first to implement GLP?
FDA
What are the key attributes of Good Documentation Practices?
Documentation should be ALCOA -
Attributable
Legible
Contemporaneous
Original
Accurate
For Grade A, GMP cleanroom requires a minimum air change rate of 20 air changes per hour
a) True
b) False
b) False.
The number of air changes will depend on the room classification and the level of activity conducted within the room. Guidance figures of a room recovery within 10-15 minutes are provided in PE009-12 Annex 1.
According to Eudralex Volume 4, production of different radioactive products in the same working area (i.e. hot-cell, LAF unit), at the same time can be performed.
a) True
b) False
b) False
List all the parameters that may be checked during method validation.
Specificity
Precision
Accuracy
Linearity
Range
Stability
Limit of Detection (LOD) and Limit of Quantitation (LOQ)
Which of the following are GLP regulations or requirements?
a) 21 CFR 58
b) 40 CFR 160
c) 21 CFR 211
d) a and c only
e) a and b only
e) a and b only