Editorial: First Pharmaceutical Compounding Quality Assurance Seminar
Many thanks to the sold-out crowd of the first Pharmaceutical Compounding Quality Assurance Seminar, which was supported by Spectrum Laboratories, Analytical Research Laboratories (ARL), and the International Journal of Pharmaceutical Compounding (IJPC). "Developing a Quality Compounding Practice that Meets and Exceeds USP Standards" was held in Oklahoma City this past weekend (April 1-2). Participants were actively involved in a "first of its kind" educational experience for pharmacy compounding.
The first session began with presentations on the source and scope of quality control in pharmacy compounding (Loyd V. Allen, Jr, PhD, RPh; IJPC), followed by in-house and out-sourced testing issues (Tom Kupiec, PhD; ARL). The final topic was on the Pharmacy Compounding Accreditation Board (Ken Baker, JD, RPh; Executive Director).
The participants were divided into two groups for the second and third sessions. Each group participated in a more detailed seminar on quality issues related to United States Pharmacopeia Chapters <795>, <797>, and <1075>, and practical issues related to their implementation. The groups also participated in four hours of "hands-on" laboratory exercises with practical experience on the use of different analytical and microbiological methods in testing compounded preparations. These exercises included specific gravity, spectroscopy, sterility, endotoxin, refractive index, osmolality/tonicity, viscosity, gas chromatography, high-performance liquid chromatography, melting point, microscopy, and pH. In addition, the group was introduced to a new research-grade spectrophotometer by way of a demonstration. The spectrophotometer, which can be used in a compounding pharmacy, uses 2 microliters of sample and provides results in 10 seconds.
We want to thank all the participants who attended the seminar, and we look forward to the next program, which is tentatively scheduled for September 2006.
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief |
CompoundingToday.com continues to expand its online, searchable database of compounding related literature. This week forty items were added on COPD with emphasis on drug delivery by inhalation, as well as seven items on miscellaneous topics mentioned on the IJPC Compounder's Network List (CNL). Some examples of this week's additions are:
- Dolovich MB, Ahrens RC, Hess DR et al; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest 2005; 127(1): 335-371.
- Drobnic ME, Sune P, Montoro JB et al. Inhaled tobramycin in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection with Pseudomonas aeruginosa. Ann Pharmacother 2005; 39(1): 39-44.
- O'Callaghan C, White J, Jackson J et al. Delivery of nebulized budesonide is affected by nebulizer type and breathing pattern. J Pharm Pharmacol 2005; 57(6): 787-790.
- Poole PJ, Black PN. Preventing exacerbations of chronic bronchitis and COPD: Therapeutic potential of mucolytic agents. Am J Respir Med 2003; 2(5): 367-370.
- Rau JL, Restrepo RD. Nebulized bronchodilator formulations: Unit-dose or multi-dose? Respir Care 2003; 48(10): 926-939.
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Better Exhaust System Ductwork
When designing an exhaust system to remove air and particulates from a nonsterile work area (e.g., powder hood), use smooth-surface ductwork, not the accordion-type ducts. The reason is that powders will collect in the "valleys" of the ductwork and when the system is turned off and a change in pressure results, the powder may drift back into the room. Even though the accordion ductwork is easier and cheaper to install, in the long run, the smooth ductwork will be more cost-effective.
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