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drgopal ☆ India, 2009-09-02 13:56 (6145 d 06:11 ago) Posting: # 4141 Views: 3,565 |
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Dear all, Are there any guidelines for prerequisites in a pharmacy room? What are the minimum requirements? Thanks in advance. drgopal |
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santosh.awale ☆ Mumbai, 2009-09-11 09:06 (6136 d 11:01 ago) @ drgopal Posting: # 4189 Views: 2,793 |
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Dear drgopal, ❝ What are the minimum requirements? The minimum requirment for pharmacy room are controlled temparature cabinate to store test products, sodium vapour lamp (for dispensing of light sensitive drug), weighing balance (for powder product), measuring cylinder class A (for liquid product), hygrometer (to mesure relative humidity), stainless steel dispensing tray for test and reference product and dispensing cups. Regards, Santosh |
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drgopal ☆ India, 2009-09-11 15:36 (6136 d 04:31 ago) (edited on 2009-09-11 21:59) @ santosh.awale Posting: # 4194 Views: 2,776 |
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Dear Mr Santosh, Thanks for the reply. Can the investigative product be stored in a shelf instead of a humidity chamber while maintaining the temperature and humidity of the pharmacy room? Regards, drgopal -- Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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Ohlbe ★★★ France, 2009-09-12 00:09 (6135 d 19:58 ago) @ drgopal Posting: # 4196 Views: 2,730 |
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Dear drgopal, ❝ Can the investigative product be stored in a shelf instead of a humidity chamber No guideline that I know of requests the use of a humidity chamber. You should follow the storage conditions communicated by the sponsor (e.g. store below 25°C), and you should be able to prove it by recording the temperature and, if needed, humidity. Regards Ohlbe — Regards Ohlbe |
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Ohlbe ★★★ France, 2009-09-12 00:06 (6135 d 20:00 ago) @ santosh.awale Posting: # 4195 Views: 2,785 |
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Dear Santosh and drgopal, ❝ sodium vapour lamp (for dispensing of light sensitive drug) Have a look at this thread for a previous discussion on the dispensing of light-sensitive drugs. Remember also that you should have personnel qualified and trained to do the dispensing. Dispensing is a critical step in your trial. According to presentations made at the EGA meetings in 2007 and 2008, European inspectors tend to consider this as packaging and not just dispensing. Which means that they expect it to be done under GMP - and to be documented as such. Regards Ohlbe — Regards Ohlbe |
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