WorksheetsCold Chain & Production
Total questions: 15
Worksheet time: 8mins
Which of the following statements about premise is TRUE?
I. Adequately sized storage area
II. Orderly & segregated storage of products in storage area
III. Computer system can replace physical segregation of product
IV. Dedicated reject area
I & II
I, II & III
I, II & IV
All of above
Documents shall:
be approved, signed and dated by an authorized person
be written in detail and in simple language that can be easily understood by the user
have tittle, nature and purpose shall be clearly stated
All of the above
A distinction should be made between what types of complaints:
Complaints on price and complaints on currency.
Complaints from government and complaints from general public.
Complaints on quality of the product and complaints related to distribution.
Complaints received by letter and complaints received by e-mail.
PRT stands for:
Pathogen Reactivity Test
Purely Research Technology
Pathogen Reaction Technology
Pathogen Reduction Technology
How the wrong entry of any information can be corrected?
Wipe away errors with correction fluid.
Cross and write the correct entry.
Cross with sign and date with the reason with right word.
None of the above.
The potential benefit of Mirasol is:
Inactivation of Pathogen only
Inactivation of Leukocytes only
Both Inactivation of Pathogen and Inactivation of Leukocytes
None of the above
What is the compound used with the Mirasol for the PRT procedure?
Psoralen
Riboflavin
Amatosalen
Sodium Hypochlorite
Which of the following statements is NOT TRUE?
Record current TTSP storage facility (cold room/fridge/freezer) temperature twice a day
Thermohygrometer needs to be calibrated at suitable interval and suitable range
Temperature Mapping is required for storage area
Alarm system is important for cold room storage
Which device as follow are/is NOT suitable to monitor freeze sensitive product?
Temperature Data Loggers
Freeze Tag
Vaccine Vial Monitor
None of the above
Which of the following statements is TRUE?
I. Ice pack should be immediately put into cold box after taking out from freezer.
II. Cold chain product shipping container shall only include details of storage temperature and time of packing.
III. A packed shipping container should be placed in cold room while waiting for transportation.
I & II
I, II & III
II & III
None of the above
The term qualification usually applies to:
I. Processes
II. Test Method
III. Premises
I & II
I & III
III only
All of the above
The term validation usually applies to:
I. Materials
II. Systems
III. Equipment
I & III
II only
II & III
None of the above
Temperature Mapping Study is the activity to measure and document the temperature distribution within an equipment by locating the hottest and coldest spot.
True
False
The Temperature Mapping may also be used to identify zones where remedial action need to be taken.
True
False
A Temperature Mapping Study takes place for a defined time period.
True
False
