SOP for Temperature and Humidity Monitoring in Pharmaceutical Industry

This document details the procedure for the Daily Temperature and Humidity Monitoring. It is the policy of XYZ Limited that written procedure shall be followed for    Daily Temperature and Humidity Monitoring.  The purpose of this procedure is to ensure that all types of materials are stored in suitable storage conditions so as to prevent deterioration of contents and compliance with regulatory requirements.

 {tocify} $title={Table of Contents}

This procedure is applied during Daily Temperature and Humidity Monitoring.

RESPONSIBILITY

Persons along with their responsibilities are given below:

Executive- Corporate/Quality Assurance: - To prepare the SOP and follow the same

Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst:- To follow the SOP accordingly

Manager – Quality Assurance: - To ensure the implementation of SOP

In charge-Warehouse: - To ensure implementation of SOP 

5.0 PROCEDURE

5.0.1 ALL DRUGS AND DRUG PRODUCTS SHOULD BE STORED ACCORDING TO THE CONDITIONS DESCRIBED ON THE LABEL. WHEN SPECIFIED ON THE LABEL, CONTROLS FOR HUMIDITY, LIGHT, ETC. SHOULD BE IN PLACE.

5.02 For Daily Temperature & Humidity monitoring Digital or Manual (Wet & Dry) hygrometer can be used.

5.0.3 Temperature should be controlled and monitored using calibrated monitoring devices (Digital or Wet &Dry bulb hygrometer) and records of temperature should be maintained.  Monitoring is conducted at points representing the extremes of temperature range based on Temperature mapping.

5.04 Fix the position of the device used for Daily Temperature & Humidity monitoring. 

5.0.5 Place Wet &Dry bulb hygrometer in a position with a steady flow of air around the mercury bulbs.

5.0.6 Fill the cistern with Demineralised water to avoid the wick becoming clogged with impurities. The wick should be changed regularly to ensure a constant flow of moisture to the wet bulb.

5.0.7 Allow the mercury columns remain steady.

5.0.8 Take the reading of Wet and Dry bulb columns.

5.0.9 Subtract the reading of the Wet-bulb column from that of a dry column, thus arriving at depression value.

5.1.0 In a provided table, locate the dry bulb and the depression value given by the hygrometer and at the intersection of the two columns, read off the percentage humidity.

5.1.1 The following example illustrate the method of using the tables--

         Reading of Dry bulb--------------------------------30˚C

         Reading of Wet bulb -------------------------------25˚C 

         Hence the depression of the Wet Bulb--------30˚C- 23˚C = 7˚C

         Reading directly from the tables, the relative humidity is 53%

5.1.2 Temperature and Relative humidity monitoring shall be done twice a day i.e. morning (9.00   to 10.00) and afternoon (16.00 to 17.00) by using a Hygrometer.

 5.1.3 In the case of a Digital Hygrometer take a reading of Temperature & Humidity displayed on the screen.

5.1.4 The record of temperature and humidity shall be maintained on SOP Daily Temperature and Humidity Monitoring.

5.1.5    In the morning, check and record the current Temperature and Humidity from the hygrometer (digital/Wet & Dry bulb)

5.1.6    In the afternoon, check and record the current Temperature and Humidity  from the hygrometer  (digital/Wet &Dry bulb)

5.1.7    In case of excursion, record and explain the excursion. Written procedures should be available describing the actions to be taken in the event of temperature excursions outside the labeled storage conditions.   

5.1.8 If excursion cannot be explained, inform to Maintenance and Quality Assurance Manager for necessary action.

 Acceptance criteria (for building material section)

Temperature: 27±2°C

Humidity         : 65±5%RH 

5.2.1 The record of temperature and humidity of the Building   material  section   shall be maintained   as per   Appendix   II  APL/CQA/SOP-032/FR-02

5.3 Acceptance criteria

Temperature: NMT 27°C

Humidity:-NMT   55%RH

Note:    For a normal product that is not highly sensitive to humidity  it should be NMT 55%RH 

 but in the case of specific products humidity shall be maintained as per requirement.

Examples of certain products for which Temperature &Humidity conditions are maintained

Empty Capsules Storage-----40-65%RH

Capsule filling area& For Antibiotics ---------35-50%RH

Highly sensitive items like

 Cloxacillin sodium ------25-35%RH

Clavulanate Potassium----25-35%RH

Dry place as per USP correspondence to about 45%RH

Ranitidine,    Omeprazole,   Lasnoprazole, --------------- 35±5%RH

Rabeprazole, Pantoprazole, Ethambutol ----------------- 35±5%RH

5.4  ABBREVIATIONS

NMT:      Not more than

NLT:       Not less than

QA:       Quality Assurance

RH:      Relative Humidity

%     :       Percentage

  ˚C:       Degree Celsius