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GMP / Pharmaceutical Temperature Monitoring

Pharmaceutical temperature monitoring / GMP Monitoring

DRAP GMP Compliance Checklist our system addresses

Section Compliance check description (DRAP GMP audit checklist 2018)
2.3 Premises
  Does the facility have appropriate controls to maintain required parameters e.g. temperature, relative humidity and pressure differentials etc?
9.1 Stability studies
  Does the company have a prospective and concurrent stability studies program based on SOP and utilizing proper equipment i.e. climatic chambers maintained at 30° C / 65% RH for ambient and 40° C / 75% RH for stress conditions and continuously monitored for temperature & RH?
14.1 Manufacturing area equipment, material / component
14.1.4 Does the equipment & facilities have appropriate controls to maintain required parameters e.g. temperature, relative humidity, pressure differentials etc?
14.1.6 Equipment / Instruments calibration & preventive maintenance Does the facility have approved written procedures for checking and calibration of each piece of measurement equipment? Are records of calibration checks and inspections maintained in a readily retire able manner?
14.2 Raw Material
14.2.2 Does the store premises allow storage of raw materials at various temperatures?
14.2.3 If answer yes to the above what are the controls to log any irregularities?
14.3 Purified and water for injection system
14.3.22 Is the system capable of being maintained at 80 °C with continuous temperature monitoring devices?
14.3.44 At what temperature and for how long are WFI samples incubated?
14.5 Sterilizer / Oven loading room
14.5.4 Does the sterilizer meet the following criteria:

d.         Is it capable of using thermocouples in the chamber for measuring load temperatures?

e.         Is it equipped with a recording device for checking temperature and pressure?

14.5.5 Does the oven meet the following criteria?

d.         Does it have the resistance temperature device in the return air duct for control temperature?

e.         Can it maintain an empty chamber temperature distribution of +/- 25 °C at 300 °C when utilized for depyrogeration and at a 90 °C +/- 20 °C for sterilization?

f.          Is it equipped with a temperature recorder?

14.9 Environmental Monitoring
14.9.1 Are laminar flow hood and HVAC system which serve the sterile operations areas validated?
14.9.6 Is there an environmental monitoring program for the aseptic batching area, sterile filling room, sterile filling line and ancillary areas?
14.9.9 Is environmental monitoring equipment on a maintenance / calibration program?
14.9.10 At what temperature for how long are environmental monitoring samples incubated?
14.10 Aseptic batching area
14.10.10 Are the room air pressures, temperature, humidity and filter pressure drop automatically monitored, alarmed and recorded?
14.11 Filling Rooms
14.11.10 Are room air pressure, temperature, humidity and filter pressure drop automatically monitored, alarmed and recorded?
14.11.33 Is QC/QA informed of manufacturing problems that could affect product quality? (Alert Notice System).
14.16 Manufacturing – Oral Dosage Form
14.16.6 What are the controls for the temperature logging of the dryers?
14.16.15 Are there temperature log sheets maintain during the manufacturing cycle?
17 Warehousing / Distribution
17.1 Are material stored under conditions as per the storage instructions on the label?
17.6 Are minimum and maximum temperatures in the store recorded?
18 Environment, Health & Safety
18.7 Is the control of air pressure, dust humidity and temperature adequate for the manufacturing, processing storage or testing of the drug products?

Pharmaceutical temperature monitoring system in Pakistan per GMP?

DRAP (Drug Regulatory Authority) issues guidelines for pharmaceutical temperature monitoring which dictate that controlled drugs and vaccines meet certain criteria for usage to deliver maximum effectiveness and shelf-life.  The pharmaceutical industry as a whole is subject to regular compliance audits ensuring that these guidelines are met and are a part of the regulatory process.

Pharmaceutical Temperature Monitoring for Compliance

A comprehensive regimen of pharmaceutical temperature monitoring and accurate record-keeping is an integral part of the compliance strategy for any facility producing, storing and distributing pharmaceutical products. Manual pharmaceutical temperature monitoring at the level of detail needed is time-consuming and is subject to human error. Often times, qualified resources are tied up in the process.

Following Environmental parameters are considered by GMP that our system addresses

  • Temperature & Humidity of raw material storage rooms
  • Positive pressure maintained in the processing areas
  • Temperature & Humidity of processed products in storage rooms
  • Temperature & Humidity in stability chambers

Environment Monitoring to Manage Financial Risk

When manufacturing and storing pharmaceutical products, your inventory is a potential compliance risk.  Using IoTCloudware Monitoring System gives you the peace of mind that your valuable inventory is fully protected and that in process environmental parameters of each of your batch are adequate.

  • Eliminate Compliance Risk
  • Free Up Valuable Human Resources
  • Protect Invaluable Assets
  • Deliver Return on Investment

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