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PharmTech.com Quality and Regulatory Sourcebook March eBook 2023 Pharmaceutical Technology ® 27 Manufacturing cy totoxic, and other hazardous materials). When possible, ded icat ion of equ ipment or si ng le-use equipment should be practiced [to] reduc[e] chances of bioburden and cross contamination. Ma i nt a i n i ng t he clea n i ng records [a nd] est ab- lishing cleaning procedures for the equipment used in t he compounding process [are] a lso critica l to m a i nt a i n t he s a n it y of t he d r u g comp ou nde d . Dedicated instr uments/equipment is required to avoid cross contamination. Quality control PharmTech: How do drug compounders ensure the medicines they create meet quality standards? S i n g n u r k a r ( S y n g e n e ) : T h e c o m p o u n d i n g o f d r u g s m u s t b e r e p r o d u c i b l e t o d e - l iver t he requ i red dose con sis- tent ly to pat ient s t h roug hout m a n y c o m p o u n d i n g c y c l e s . T he compou nder shou ld h ave good k nowledge a nd sk i l l s to comp ou nd t he me d ic at ion a s required and should be qualified and trained. T he compounders shou ld es- tablish and fol low various risk m a n agement a s pec t s s uch a s: a defined set of procedures and maintain[enance of ] checklists w it h complete i n st r uc t ion s of compou nd i ng; use of dose ca l- c u l at ion tool s s uc h a s dosage cha r t s a nd for mu lae ba sed on body weig ht , c a lc u l at ion s for m e a s u r i n g / w e i g h i n g t h e i n - g red ient s a s requ i red; a sept ic h a nd l i n g i n l a m i n a r a i r f low c a bi ne t s (a s on r e q u i r e d), hy- giene, [a nd] a ny speci f ic clot h- i n g o r p e r s o n a l p r o t e c t i v e equipment (PPE), as appropriate to t he me d ic at ion b ei n g com- p o u n d e d ; n e c e s s a r y i n s t r u - me n t s/e q u ipme n t t o pr e p a r e t h e c om p o u n d e d d r u g s; c on- duct[ing] in-use stability studies to understand the stability of the compounded drug; conduct[ing] recover y studies to understand t h e d o s e t r a n s f e r r e d t o t h e pat ient f rom t he compou nded container-closure system; proper l a b e l i n g ( i f p o s s i b l e , u s i n g pre-printed labels); using an infu- sion monitoring form/checklist to mon itor t he dose ad m i n ist rat ion rate i n ca se of injectables. Schniepp/Lynn (RCA): Compounded drugs are requ i red to mee t s a fe t y a nd qu a l it y s t a nd a rd s. That means they must perform process validations, method validations, smoke studies, and stability to support the manufactured product. PharmTech: W hat reg ulations must dr ug com- pounders follow? Schniepp/Lynn: Drug compounders need to fol- low full good manufacturing practice (GMP) as de- fined by FDA. This includes 21 Code of Federal Reg- ulations 210 and 211 and FDA guidance documents Cur re nt G ood Manufact ur ing P ract ice — Guidance Kenosha WI 262.925.4740 Elkhart IN 574.295.6605 From custom folding cartons to pressure-sensitive labels and package inserts, Colbert Packaging oers a complete array of safe, smart and sustainable packaging solutions and brand protection services. With each production run, we know the most important feature is what's INSIDE. ONE CLEAN C A R T O N ® Eco-f riendly, low migration, water-based/agri-based packaging Anti-counterfeit and security features 100% vision inspection for quality assurance