Quality Assurance and Control in Pharmaceuticals
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Questions and Answers

What is one of the primary reasons for reducing particle size in pharmaceuticals?

  • To increase manufacturing costs
  • To facilitate powder mixing (correct)
  • To enhance color and appearance
  • To create a more complex formulation

    • Which of the following is NOT a principal means of size reduction?

  • Impaction
  • Attrition
  • Cutting or shearing
  • Granulation (correct)

    • In the selection of a milling machine, which factor is essential to consider regarding the feedstock?

  • The color of the feedstock
  • The cost of the milling process
  • The properties of the feedstock (correct)
  • The brand of the milling machine

    • Which regulatory authority corresponds with the United Kingdom?

    <p>MHRA</p> Signup and view all the answers

    What is the goal of using size reduction in the context of drug pharmacological performance?

    <p>To improve the pharmacological performance of the drug</p> Signup and view all the answers

    What is required to be stated in new documents after a revision?

    <p>Date of revision</p> Signup and view all the answers

    What must happen to obsolete documents?

    <p>They should be retrieved and archived</p> Signup and view all the answers

    Which of the following is NOT considered a record of activities related to document management?

    <p>Sales transactions</p> Signup and view all the answers

    Who is responsible for approving every document revision?

    <p>An authorized person</p> Signup and view all the answers

    Which documents should be designed, prepared, and reviewed with care?

    <p>Quality management documents</p> Signup and view all the answers

    What is the purpose of maintaining organized files in documentation?

    <p>To keep a history for a specific time</p> Signup and view all the answers

    Which aspect is crucial for ensuring product quality according to the document management process?

    <p>Systematic actions and techniques</p> Signup and view all the answers

    What kind of records must be kept as part of documentation principles?

    <p>Training schedules and evaluations</p> Signup and view all the answers

    What does the Master Record contain?

    <p>Formulation, specifications, and quality assurance requirements</p> Signup and view all the answers

    What defines a Drug Importer?

    <p>An establishment that imports for distribution or wholesale.</p> Signup and view all the answers

    What is the main purpose of documentation in drug manufacturing?

    <p>To ensure all manufacturing methods and responsibilities are specified</p> Signup and view all the answers

    Which activity requires Standard Operating Procedures (SOPs)?

    <p>Batch release or rejection</p> Signup and view all the answers

    What is meant by Theoretical Yield?

    <p>The expected output assuming no losses during production</p> Signup and view all the answers

    Which component is NOT included in pharmaceutical preparations?

    <p>Marketing expenses</p> Signup and view all the answers

    Who is classified as a drug manufacturer?

    <p>An establishment that creates drug articles</p> Signup and view all the answers

    What is a key requirement for the preparation of SOPs?

    <p>They should be designed, prepared, reviewed, and distributed with care</p> Signup and view all the answers

    What action should be taken if an incorrect entry is made on a document?

    <p>Draw a line across the original entry and mark it obsolete.</p> Signup and view all the answers

    Which of the following should NOT be included in a Batch Processing Record?

    <p>Suppliers' contact details</p> Signup and view all the answers

    What is required when documenting a correction?

    <p>The correction must be initialed and dated.</p> Signup and view all the answers

    Which of the following describes an obsolete document?

    <p>A document that should be marked 'obsolete' and archived.</p> Signup and view all the answers

    What should be included in the quality control record?

    <p>The original batch number if applicable</p> Signup and view all the answers

    What characteristics define a Quality Control number?

    <p>It is a unique identifier for tracking quality control results.</p> Signup and view all the answers

    Which of the following is NOT a component of a document's content?

    <p>Document approval rating</p> Signup and view all the answers

    What is the primary purpose of maintaining proper records in quality control?

    <p>To guarantee transparency and traceability of quality processes</p> Signup and view all the answers

    What is the primary purpose of diluents in tablet formulation?

    <p>To increase the bulk for processing and handling</p> Signup and view all the answers

    Which of these are NOT considered suitable characteristics for a good diluent?

    <p>Hygroscopic</p> Signup and view all the answers

    What is the main role of binders in tablet formulation?

    <p>To ensure tablet cohesiveness</p> Signup and view all the answers

    Which of the following is a characteristic of an ideal lubricant?

    <p>Low shear strength with strong cohesive tendencies</p> Signup and view all the answers

    Which mechanism of action is associated with disintegrants?

    <p>Porosity and capillary action</p> Signup and view all the answers

    What type of agents are glidants categorized as?

    <p>Fine powders to improve flow properties</p> Signup and view all the answers

    Which substance is NOT typically used as a binder in tablet formulations?

    <p>Sorbitol</p> Signup and view all the answers

    Which of the following is a function of glidants in tablet production?

    <p>Reduce friction between particles during compression</p> Signup and view all the answers

    Study Notes

    Quality Assurance and Control (QA/QC)

    • Master Record includes formulations, specifications, manufacturing procedures, quality assurance requirements, and labeling of finished products.
    • Drug Articles are substances aimed at diagnosis, treatment, prevention of disease, or altering body structure/function.
    • Pharmaceutical Preparations consist of active pharmaceutical ingredients (API) and excipients formulated for human or animal use.

    Drug Establishments and Roles

    • Drug Importer imports raw materials or finished products for distribution.
    • Drug Manufacturing encompasses creation, packaging, labeling, and testing of drug articles.
    • Standard Operating Procedures (SOPs) guide essential activities such as batch release, validation, and personnel training.

    Documentation and Procedures

    • Documentation provides an audit trail and ensures quality control responsibilities are communicated and authorized.
    • Quality Control records document test dates, material identification, supplier information, and batch numbers.
    • Document control policies include taking obsolete documents from users, archiving them, and marking them appropriately.

    Batch Processing Records

    • Prepared for each product batch, including details like product name, batch number, formula, and processing steps.
    • Must include revision numbers, approval date, preparer's signature, and quality control results.
    • Importance of accurate entries, corrections must be initialed and dated without obscuring original data.

    Regulatory Bodies

    • Global regulatory agencies overseeing pharmaceutical practices include:
      • MHRA (UK)
      • TFDA (Taiwan)
      • HSA (Singapore)
      • DCA (Malaysia)
      • NMPA (China)
      • DCGI (India)
      • TFDA (Thailand)

    Good Manufacturing Practices (GMP)

    • Guidelines include PIC(s), EU, USA FDA CFRs 210 & 211 & 820, ISO standards, and WHO GMP Guidelines.
    • Documents must maintain a complete history from starting materials to finished products.

    Unit Operations in Pharmaceutical Manufacturing

    • Size Reduction improves processing, pharmacological performance, and transportation efficiency by reducing bulk volume.
    • Methods of size reduction include cutting, compressing, impaction, attrition, and combined techniques.

    Role of Excipients

    • Diluents increase bulk for tablet processing; ideally, they should be inert, non-hygroscopic, and cost-effective. Common diluents include lactose, starch, and microcrystalline cellulose.
    • Binders ensure tablet integrity and flow by promoting cohesiveness; can be applied as solutions or powders.
    • Lubricants minimize friction during compression processes; an ideal lubricant has low shear strength.

    Glidants and Disintegrants

    • Glidants enhance flow properties during tablet compression and are added just before compression.
    • Disintegrants assist in breaking up tablets in the body, facilitating dissolution through mechanisms like swelling and capillary action.

    Objectives of Documentation

    • Document activities related to maintenance, storage, quality control, and primary distribution.
    • Ensure all records are organized, maintained for an established period, and periodically reviewed for relevance.

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    Manufacturing Good Manufacturing Practices (GMP) PDF

    Description

    Explore the critical aspects of Quality Assurance and Control (QA/QC) in the pharmaceutical industry. This quiz covers master records, drug articles, pharmaceutical preparations, and the roles of drug establishments. Test your knowledge on documentation and procedures essential for maintaining quality standards.

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