|
This newsletter is a continuation of our series on the proposed USP <795> Pharmaceutical Compounding—Nonsterile Preparations. Here, we look at some comments on selected aspects of Sections 11 and 14. The numbers on the left are the same as those actually in the chapter. Only those items with comments are reproduced.
11. QUALITY ASSURANCE AND QUALITY CONTROL
12. CNSP HANDLING, PACKAGING, STORAGE, AND TRANSPORT
| 619 | | 12.1 Handling of CNSPs |
| |
| 625 | | 12.2 Packaging of CNSPs |
| |
| 635 | | 12.3 Storing CNSPs within the Compounding Facility |
| |
| 647 | | The humidity of the storage room temperature area should be maintained |
| 648 | | at or below 60%. |
| |
| +Source of this requirement? As previously mentioned, this may be extremely difficult or impossible to obtain in coastal areas, especially in the south. Or, does this simply apply to CNSPs that are ready to dispense that could be stored in a "cabinet" and not a "room"? If they are properly packaged in "Tight-Containers," then there is no need for this requirement as a Tight-Container is impervious to moisture. |
| |
| 649 | | The compounding facility must adhere to SOPs to detect and prevent |
| 650 | | temperature excursions within the controlled temperature area. When it is |
| 651 | | known that a CNSP has been exposed to temperatures either below or above |
| 652 | | the storage temperature limits for the CNSP, personnel must determine |
| 653 | | whether the CNSP integrity or quality has been compromised and, if so, the |
| 654 | | CNSP must be discarded. |
| |
| +The definition of "Controlled Room Temperature" should be mentioned here where excursions are allowed as per the definition. There should be very few instances where the CNSP must be discarded as per that definition. |
| |
| 655 | | 12.4 Shipping and Transporting CNSPs |
| |
| 13 COMPLAINT HANDLING AND ADVERSE EVENT REPORTING |
| |
| 670 | | 13.1 Complaint Handling |
| |
| 695 | | 13.2 Adverse Event Reporting |
| |
| 707 | | 14. DOCUMENTATION |
Actually we have no comments on Sections 13 and 14.
Please let USP know of any comments you might have on the proposed chapter. Do this by going to:
http://www.usp.org/compounding/general-chapter-795
You CAN make a difference!
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
|
