Pharmacy and Climate Zone Quiz

Climate Zones and Storage Conditions

• Climate zone 1 represents the subtropical zone.
• The recommended temperature range for refrigerated storage is 2-8°C.
• A "cool place" for storing medications is between 8-15°C.

Batch and Pharmaceutical Manufacturing

• A batch refers to a defined quality of starting material, packaging material, or product processed in one process or series of processes.
• Before commercial distribution, manufacturers should have a high degree of assurance in the performance of the manufacturing process via well-defined compendial/non-compendial tests.

Stability Testing and Analytical Methods

• Stability indicating methods are quantitative and qualitative analytical methods that distinguish drug substances from their degradation products.
• Accelerated stability testing is a modified stability method used to quickly estimate the expiration date or life span of a product when real-time data is unavailable.
• In the development phase, a reasonable frequency of testing is considered to be up to 12 months for real-time (storage conditions) studies.

Packaging and Materials

• Packaging materials are referred to as primary or secondary according to whether they are in direct or indirect contact with the product respectively.

Pharmaceutical Manufacturing and Safety

• Air-handling systems for the manufacture of penicillin shall be completely separate from those for other drug products for human use.
• Air filtration systems shall be used when appropriate on air supply to production areas.
• Adequate lighting shall be provided in all areas, and sewage shall be disposed of in a safe and sanitary manner.

Standard Operating Procedures (SOPs)

• An authorized written procedure giving instructions for performing operations not necessary to a specific product or material but of a more general nature is an SOP.