|
Click Here - To Download Your Own Free Pharmaceutical Glossary. GxP enforcement of the COLD CHAIN equipment and data.
There are known cases where the efficacy of a drug has been directly impaired because of storage in out of specification temperatures (nearly one thousand instances in one relatively small health authority). Now that the possibility of drugs being damaged in this way is common knowledge, when a drug administered in theatre, clinic or surgery, does not perform as expected, you can expect questions to be asked. After all, the drug is manufactured and tested in accordance with rigorously applied and executed rules and regulations. It is administered to the patient in accordance with set pre approved protocols. The only information that appears to be missing, is reliable validated COLD CHAIN data. There is now legislation in nearly all countries to ensure that the COLD CHAIN (manufacture – Storage – wholesale – retailer – dispensary) temperature data requirements for regulatory controlled drugs are adhered to. It is therefore a requirement that where, temperatures are specified for storage, recorded historic data is kept, and that all equipment used for temperature storage purposes conforms to cGxP rules and guidelines. As detailed by the FDA, MHRA, and the Local Health Authorities. Every refrigerator, freezer, walk-in, or chilled display cabinet must have the following attributes to ensure compliance with - cGxP’s
continuing Good manufacturing/clinical/laboratory Practices).
EUROPEAN REGULATIONS. GUIDELINES ON GOOD DISTRIBUTION PRACTICE OF MEDICINAL PRODUCTS FOR HUMAN USE (94C/ 63/03) Medicinal products subject to specific storage measures (e.g. products requiring a specific storage temperature) should, on receipt, be immediately identified and stored in accordance with written instructions and with relevant legislative provisions. Temperatures should be monitored and recorded periodically. Records of temperature should be reviewed regularly. When specific temperature storage conditions are required, storage areas should be equipped with temperature recorders or other devices that will indicate when the specific temperature range has not been maintained. Control should be adequate to maintain all parts of the relevant storage area within the specific temperature range. USA REGULATIONS. TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER C--DRUGS: GENERAL PART 205 -- GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS Sec. 205.50 Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records. (3) All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records. (2) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.
Steam Quality. clich here for full details. A continuous supply of saturated steam is required for steam sterilization. Too high a level of non condensable gases will prevent the attainment of sterilization; too little moisture carried in suspension may allow the steam to become superheated during expansion into the chamber, while excess moisture may cause damp loads. Where steam systems are either routinely or irregularly shut down, large quantities of air will be present in the distribution system on restarting. It is recommended that in such circumstances a comprehensive and validated venting procedure should be applied and testing for steam quality is appropriate. Now for less than £300 you can set up and bring your steam quality testing in house. 75% of the test gear is standard laboratory hardware, the pitot and expansion tubes are now available direct from us, by return post. Click here for full details. A fully detailed PURE STEAM QUALITY VALIDATION PROTOCOL. is available from us, by direct download. Click here for full details. Where the steam generator is steam powered, one of the biggest threats to your WFI, where the steam generator is steam powered, is a steam(industrial) to steam (pure) leaks. Where the steam generator is electric powered, the biggest risk is the cascade of heating elements that are used, when one of these blows it release several hundred grams of manganese oxide (the filer in mineral insulated element) into your system. TEST REGULARLY AND BE CERTAIN. |