Questions and Answers
The ability of a particular formulation in a specific container to remain within its physical, chemical, therapeutic and toxicological specification is called:
The color for quarantine sticker is:
An example of primary packaging material is:
The following are important documents in the manufacture of drugs and cosmetics, EXCEPT:
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Retention period for finished products should be:
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Overages in the manufacture of pharmaceuticals are justified on the following conditions:
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A standard document, which gives instructions to the Production Department to produce a pharmaceutical product for distribution/sale in the market:
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A section of the warehouse which houses products which have been bottled, stripped or blister-packed, but not yet labelled or packed into boxes/cartons is called:
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CGMP means:
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This statement is true of the FIFO Policy:
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Study Notes
Drug Formulation and Stability
- Stability refers to a formulation's ability to remain within its physical, chemical, therapeutic, and toxicological specifications over time.
- Shelf-life is the period during which a product remains effective and safe for use.
- Overages in pharmaceuticals allow for stability, especially when active ingredients may degrade or be inconsistent in concentration.
Packaging Materials
- Primary packaging materials include components directly in contact with the drug, such as labels and seals.
- Quarantine stickers are usually colored yellow to indicate products awaiting testing or approval.
Manufacturing Documentation
- Key documents in drug and cosmetic manufacturing include manufacturing monographs, batch records, CGMP guidelines, and standard operating procedures. Not all documents are essential, with one type being excluded.
- The retention period for finished products generally extends up to two years post-distribution of the first lot.
Quality Control Measures
- Overages are justified when clinical studies indicate safety or when active ingredients cannot be properly standardized.
- Documents such as batch production records guide the Production Department in manufacturing pharmaceuticals.
Warehouse and Production Sections
- The Finished Goods Section houses products that are packaged but not yet labeled, waiting for quality control approval.
- The Planning and Scheduling Division works closely with the Production Control department to manage supply and distribution.
Filling and Stability Testing
- Liquid filling may use methods like volumetric filling, where liquids are pumped under constant pressure through a uniformly sized orifice.
- Stability tests, such as accelerated stability tests, assess product degradation under controlled temperature conditions.
Good Manufacturing Practices (GMP)
- CGMP stands for Current Good Manufacturing Practice, ensuring that products are produced consistently and controlled according to quality standards.
- FIFO policy is used in inventory management to ensure the oldest stock is used first, minimizing waste and expiration risks.
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Description
Test your knowledge on pharmaceutical packaging concepts and regulations. This quiz covers topics like stability, quarantine stickers, primary packaging materials, and essential documents in drug manufacturing. Challenge yourself and see how well you understand these critical aspects of the industry!
