Study Set Content:
21- Flashcard

Based on the stability of the raw materials the re assay dates are: 24 months

active ingredients, excipients

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22- Flashcard

are primary concerns for the pharmaceutical industry.

Compliance, traceability, consistency, and reliability of measurement data

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23- Flashcard

The control system(s) in place need to verify the product quality through

  •  measuring, counting, inspection and testing of the manufacturing process
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24- Flashcard

are being observed which encompass the six major systems in an industrial pharmacy

Process control systems

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25- Flashcard
  • Process control systems are being observed which encompass the six major systems in an industrial pharmacy which includes:
  1. Quality 
  2. Production 
  3. Laboratory 
  4. Materials 
  5. Facilities &Equipment 
  6. Packaging & Labeling
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26- Flashcard

Includes measures and activities to control the manufacture of in-process materials and drug products including

Production system

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27- Flashcard

Includes measures and activities to control the manufacture of in-process materials and drug products including:

  • batch compounding 
  • dosage form production 
  • in-process sampling and testing and 
  • process validation
  • establishing, following, and documenting 
  • performance of approved manufacturing procedures
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28- Flashcard
  • assure that the drug products have the identity, strength, quality, and purity they purport or represent to possess.

Written procedures;

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29- Flashcard
  • The batch shall be formulated with the intent to provide not less than 100 percent of the labeled or established amount of active ingredient

Charge-in components

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30- Flashcard

Any deviation from the written procedures shall be recorded and justified

Written procedures; deviations

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31- Flashcard
  • Requires determination of actual yields and % theoretical yield

) Calculation of yield

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32- Flashcard

Components for drug product manufacturing shall be weighed, measured, or subdivided as appropriate.

Charge-in components

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33- Flashcard

Requires proper identification (ID) of all equipment at all times during production

Equipment identification

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34- Flashcard
  • Requires establishing and following written procedures

Sampling and testing of in-process materials and drug products

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35- Flashcard

Requires establishing valid in-process specifications for such characteristics

 Sampling and testing of in-process materials and drug products

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36- Flashcard

Requires testing of in-process materials for identity, strength, quality, and purity as appropriate

Sampling and testing of in-process materials and drug products

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37- Flashcard

Requires identification and recording of a major equipment by a distinctive ID number or code in the batch production record

Equipment identification

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38- Flashcard
  • Requires establishing time limits for the completion of each phase of production when appropriate.

Time limitations on production

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39- Flashcard

shall not be performed without the review and approval of the quality control unit

reprocessing

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40- Flashcard
  1. A receiving tally report should be prepared; information indicated in a RTR is as follows: Pre-printed data 
  2. Information to be supplied by: 

A. Warehouse 

B. Quality Control

Summary Process of Material Control

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