18 Questions
What information should be marked on a sample cup?
Product Name Formula Number Batch Number Drum Number Date and Time sampled Initials
What is the purpose of specifying in-process sampling points in Master Batch Records?
To specify quality analysis checkpoints during the manufacturing process
Why must ancillary equipment be sanitized prior to use?
To prevent contamination of bulk products
What is the purpose of labeling the polybag with an 'Equipment Sanitization' sticker?
To record sanitization details and expiration dates
What is the purpose of lining an intermediary container with a plastic liner?
To prevent contamination of bulk products
Why must the intermediary container be covered with a drum liner?
To seal the product in the container
What information should be marked on the sample cup?
Product Name, Formula Number, Batch Number, Tank Number, Date and Time sampled, and Initials
What personal protective equipment is not mentioned as required for the compounder?
Steel-toed boots
Why must the Sample Thief be cleaned and sanitized before use?
To prevent cross-contamination
How many 4 oz sample cups must be taken for OTC formulas?
5
What is the purpose of the Sample Thief?
To sample the product from the bulk tank
What should be used to sample the product if the level is too low to reach by hand?
A clean, sanitized plastic or stainless steel dipper
What is the primary purpose of this procedure?
To provide a procedure for taking in-process and final bulk product samples
Who is responsible for ensuring that the manufacturing instructions and batch cards clearly indicate the points for in-process bulk testing?
Plant Manager and Technical Director
What is the recommended method for sampling the product when the level is too low to reach by hand?
Using a clean, sanitized plastic or stainless steel dipper
What type of protection is required to be worn by the Compounder during batch manufacturing?
Clean gloves, dust mask or respirator, hair net, eye protection, and GMP gowning
How should the clean sample cup be sealed after sampling the product?
By twisting the lid onto the cup
What is the responsibility of the R&D group and Technical Director?
To establish and determine when an in-process sample is needed for Quality testing
This quiz covers the procedure for taking in-process and final bulk product samples in pharmaceutical manufacturing, including responsibilities and scope.
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