Pharmaceutical Quality Control Sampling

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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?

To record sanitization details and expiration dates Signup and view all the answers

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

To prevent contamination of bulk products Signup and view all the answers

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

To seal the product in the container Signup and view all the answers

What information should be marked on the sample cup?

Product Name, Formula Number, Batch Number, Tank Number, Date and Time sampled, and Initials Signup and view all the answers

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

Steel-toed boots Signup and view all the answers

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

To prevent cross-contamination Signup and view all the answers

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

5 Signup and view all the answers

What is the purpose of the Sample Thief?

To sample the product from the bulk tank Signup and view all the answers

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 Signup and view all the answers

What is the primary purpose of this procedure?

To provide a procedure for taking in-process and final bulk product samples 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?

Plant Manager and Technical Director 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?

Using a clean, sanitized plastic or stainless steel dipper Signup and view all the answers

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 Signup and view all the answers

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

By twisting the lid onto the cup Signup and view all the answers

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 Signup and view all the answers

Pharmaceutical Quality Control Sampling

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