Pharmaceutical Quality Control Sampling

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Questions and Answers

What information should be marked on a sample cup?

  • Product Name Formula Number Batch Number Drum Number Date and Time sampled Initials (correct)
  • Product Name Formula Number Batch Number Drum Number
  • Product Name Batch Number Drum Number Date and Time sampled
  • Product Name Formula Number and Date

What is the purpose of specifying in-process sampling points in Master Batch Records?

  • To list the required personnel for sampling
  • To specify quality analysis checkpoints during the manufacturing process (correct)
  • To outline the procedure for cleaning equipment
  • To schedule equipment maintenance

Why must ancillary equipment be sanitized prior to use?

  • To prevent contamination of bulk products (correct)
  • To ensure ease of cleaning
  • To extend the equipment's lifespan
  • To reduce equipment noise

What is the purpose of labeling the polybag with an 'Equipment Sanitization' sticker?

<p>To record sanitization details and expiration dates (C)</p> Signup and view all the answers

What is the purpose of lining an intermediary container with a plastic liner?

<p>To prevent contamination of bulk products (A)</p> Signup and view all the answers

Why must the intermediary container be covered with a drum liner?

<p>To seal the product in the container (C)</p> Signup and view all the answers

What information should be marked on the sample cup?

<p>Product Name, Formula Number, Batch Number, Tank Number, Date and Time sampled, and Initials (B)</p> Signup and view all the answers

What personal protective equipment is not mentioned as required for the compounder?

<p>Steel-toed boots (A)</p> Signup and view all the answers

Why must the Sample Thief be cleaned and sanitized before use?

<p>To prevent cross-contamination (D)</p> Signup and view all the answers

How many 4 oz sample cups must be taken for OTC formulas?

<p>5 (D)</p> Signup and view all the answers

What is the purpose of the Sample Thief?

<p>To sample the product from the bulk tank (B)</p> Signup and view all the answers

What should be used to sample the product if the level is too low to reach by hand?

<p>A clean, sanitized plastic or stainless steel dipper (D)</p> Signup and view all the answers

What is the primary purpose of this procedure?

<p>To provide a procedure for taking in-process and final bulk product samples (A)</p> Signup and view all the answers

Who is responsible for ensuring that the manufacturing instructions and batch cards clearly indicate the points for in-process bulk testing?

<p>Plant Manager and Technical Director (D)</p> Signup and view all the answers

What is the recommended method for sampling the product when the level is too low to reach by hand?

<p>Using a clean, sanitized plastic or stainless steel dipper (A)</p> Signup and view all the answers

What type of protection is required to be worn by the Compounder during batch manufacturing?

<p>Clean gloves, dust mask or respirator, hair net, eye protection, and GMP gowning (A)</p> Signup and view all the answers

How should the clean sample cup be sealed after sampling the product?

<p>By twisting the lid onto the cup (C)</p> Signup and view all the answers

What is the responsibility of the R&D group and Technical Director?

<p>To establish and determine when an in-process sample is needed for Quality testing (D)</p> Signup and view all the answers

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