Identification of Particles in Parenteral Drug Raw Materials

Reference

1. 1.↵
   1. Barber TA

   . Control of Particulate Matter Contamination in Healthcare Manufacturing; CRC Press: Boca Raton, FL, 2000.
2. 2.↵
   1. Shearer G.

   Contaminant Identification in Pharmaceutical Products. The Microscope, 2003, 51 (1), 3–10.

   OpenUrl
3. 3.↵
   Dosage Form Drug Manufacturers cGMPs (10/93), GUIDE TO INSPECTIONS OF DOSAGE FORM DRUG MANUFACTURER'S - CGMPR'S Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Cleaning procedures should be monitored at appropriate intervals after validation to ensure that these procedures are effective when used during routine production. Equipment cleanliness can be monitored by analytical testing and visual examination, where feasible. Visual inspection can allow detection of gross contamination concentrated in small areas that could otherwise go undetected by sampling and/or analysis.
4. 4.↵
   European Pharmacopoeia, Japanese pharmacopeia, USP Chapter <790> 2014, and USP <1790> 2017.
5. 5.↵
   21 CFR 211, §211.82, Receipt and storage of untested components, drug product containers, and closures, and §211.170, Reserve samples.
6. 6.↵
   Code of US Federal Regulations as per the Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist.