Monday, June 22, 2009

Good Storage Practices"

The new WHO document on GMP-compliant storage represents a complement to existing GMP regulations issued by WHO. These new Good Storage Practices are valid not only for manufacturers of medicinal products, but also for pharmaceutical importers, contractors and wholesalers.

The focus topics are:

  • Personnel
  • Premises and facilities
  • Storage requirements
  • Returned goods
  • Dispatch and transport
  • Product recall

Compared to the former FIP Guideline, several new requirements have been added, some old ones, specified. Here some examples:

  • Precautions must be taken to prevent unauthorised persons from entering storage areas.
  • Materials and pharmaceutical products must not be stored directly on the floor.
  • There should be written programmes for many work routines (sanitation, pest control, measures in case of spillage, cleaning procedures for the sampling area, handling of returned goods, etc.).
  • Computerised systems used for storage administration (incl. quarantine and storage of rejected materials) have to be validated.
  • The traditional term "First in – First out" (FIFO) is now replaced correctly by the more specific "first expired/first out" (FEFO) principle.
  • In addition to the usual GMP requirements on the monitoring of storage conditions (temperature recording with calibrated equipment), temperature mapping should prove the uniformity of the temperature.
  • Returned goods may only be returned to saleable stock after the quality has been re-evaluated.
    In case patients have returned pharmaceuticals, these must not under any circumstances be returned to the saleable stock.
  • As for transport, especially the use of dry ice in cold chains is discussed (danger of damaging materials by freezing them accidentally) and the monitoring of transport conditions with the help of appropriate recording devices is recommended.

An appendix to the new WHO Guideline lists standardised storage and labelling conditions for drug products, which had already been fixed by WHO in this form in 1996.

Unfortunately, this list does not contain any reference to the Controlled Room Temperature mentioned in the USP under "Stability" in the General Chapter <1151>. The controlled room temperature takes the mean kinetic temperature into account and allows thus for a certain flexibility regarding deviations from the prescribed storage temperature.

By the way, this concept of mean kinetic temperature has also been mentioned in the European CPMP Note for Guidance on Declaration of Storage Conditions for Medicinal Products in the Product Particulars and Active Substances (CPMP/QWP/609/96/Rev.1).

Therefore, it would also have been desirable to read this term in WHO's new Good Storage Practices. But the new Guide just says that temperature deviations may be tolerated only during short-term interruptions, e.g. during local transportation.


Author:
Dr G√ľnter Brendelberger
CONCEPT HEIDELBERG

No comments: