SOP for procedure for recording of Temperature and Humidity in Stores Department:Pharmaceutical Guidelines

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SOP for procedure for recording of Temperature and Humidity in Stores Department

LABELS: HUMIDITY MONITORING, STORAGE AND RETRIEVAL, STORAGE TEMPERATURE, TEMPERATURE HUMIDITY MONITORING

Pharmaguideline

Pharmaguideline

1.0 OBJECTIVE: To lay down a procedure for recording of Temperature & Humidity in Stores Department. 2.0 SCOPE: This SOP shall be applicable for Dispensing Room, Sampling Room, RM Store, Foil Store, PM Store, BSR & Cold Storage at Stores Department. 3.0 RESPONSIBILITY: Regulatory Guidelines Stores Officer/Assistant What is cGMP? 4.0 PROCEDURE: ISO Guidelines 4.1 Store person shall ensure that all the air conditioners and AHUs of the respective store area WHO Guidelines are ON. US-FDA Guidelines 4.2 Store person shall note down the temperature & humidity twice in a day for Dispensing ICH Guidelines Room, Sampling Room & RM Store. MHRA-UK Guidelines 4.3 Store person shall note down the temperature twice in a day for RM Store, Foil Store, PM MCC Guidelines -South Africa Store, Bonded Store Room and Cold Storage. TGA Guidelines-Australia 4.4 Specific time for noting temperature shall be 8.00 to 9.30 am & 12.00 to 13.30 pm Hrs MCA Guidelines-Zimbabwe 4.5 If any abnormalities are observed during the recording, store person shall inform to Store Schedule M-India Head. European Guidelines
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SOP for procedure for recording of Temperature and Humidity in Stores Department:Pharmaceutical Guidelines

4.6 Store Head in turn shall inform the observed abnormalities to HOD QA & QC, Unit Head and MEDSAFE Guidelines -Newzeland Engineering Head for further rectification and action. GCC Guidelines -Gulf PDMA Guidelines -Japan NOTE: Temperature and relative humidity is important from the point of PANDRH Guidelines -American view of PIC/S Guidelines To avoid degradation of products. IPEQ Guidelines Drugs & Cosmetics Act-India To avoid damage to hard gelatin capsule shells. APIC Guidelines Ensure the thermometer / temperature indicator is calibrated. EU Guidelines Acceptance Criteria for Temperature & Humidity Dispensing Room : Temp. NMT 25C & Humidity NMT 555% Sampling Room : Temp. NMT 25C & Humidity NMT 555% Recent Updates RM Store-I : Temperature NMT 30C FDA Draft New RM Store-II : Temp. NMT 25C & Humidity NMT 555% WHO Recent Publications Foil Store : Temperature NMT 25C WHO Pharmaceuticals Newsletter PM Store : Temperature NMT 30C Drug Alerts BSR : Temperature NMT 25C Cold Store : Temperature between 2C to 8C

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Disclaimer: The information provided here is only for education purpose. We don't have any contract or relation with any health organization or agency of any country. Our aim is to share knowledge to pharmaceutical professionals and students. www.pharmaguideline.com will not liable for accuracy, correctness, errors in information or any loss or damage due to the information published on the site. Copyright 2008-2013

2. SOP for procedure for recording of Temperature and Humidity in Stores Department 3. SOP for procedure for storage of temperature sensitive raw materials 4. SOP for procedure for conduct a temperature mapping exercise in store to identify the
http://www.pharmaguideline.com/2010/03/sop-for-procedure-for-recording-of_19.html[1/21/2013 11:09:25 AM]

SOP for procedure for recording of Temperature and Humidity in Stores Department:Pharmaceutical Guidelines

location of the worst point at which the thermometer and hygrometer for daily monitoring needs to be placed

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