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Pharmaceuticals: Sterility Test

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Questions and Answers

What is the minimum duration for which temperature monitoring data should be retained?

The duration of the storage facility's operation

The duration of the calibration cycle

Shelf-life of the material

Shelf-life of the material plus 1 year (correct)

What is the primary purpose of temperature mapping in a storage facility?

To determine the shelf-life of the stored material

To demonstrate uniformity of the temperature across the facility (correct)

To calibrate the temperature monitoring equipment

To identify the location of expired stock

How often should equipment used for monitoring storage conditions be calibrated?

At the time of installation only

At defined intervals (correct)

When the storage facility is renovated

When the equipment is moved to a new location

What information should be included in the written instructions and records in the storage areas?

The handling of expired stock, storage procedures, and the route of materials and pharmaceutical products Signup and view all the answers

What is the purpose of maintaining records for each delivery of materials and pharmaceutical products?

To document the receipt, storage, and handling of materials and products Signup and view all the answers

What is the recommended system for maintaining records of receipts and issues of materials and pharmaceutical products?

By batch number Signup and view all the answers

Why is it essential to respect pharmacopoeial requirements and current national regulations concerning labels and containers?

To ensure the quality of the stored materials and products Signup and view all the answers

What is the primary purpose of labelling and containers in storage?

To protect the stored materials and products from contamination Signup and view all the answers

What should be included in the records maintained for each delivery of materials and pharmaceutical products?

The description of the goods, quality, quantity, supplier, supplier's batch number, date of receipt, assigned batch number, and expiry date Signup and view all the answers

Why is it essential to maintain comprehensive records of receipts and issues of materials and pharmaceutical products?

To ensure accountability and traceability throughout the supply chain Signup and view all the answers