Are Your APIs Free of Dirt?
Contamination by foreign particles
has been covered only to a small extent in
regulatory and compendial guidelines, and, even then, mostly for parenteral
The European Pharmacopoeia only covers particle contamination
of oral herbal medicines.
To cover this gap, the Active Pharmaceutical
Ingredients Committee (APIC) and the International Pharmaceutical Excipients
Council (IPEC) published position papers in 2015 explaining how pharmaceutical
manufacturers should deal with particles in APIs and excipients
PDA recently stepped in and published
Technical Report No. 78: Particulate Matter in
Oral Dosage Forms
in December 2017 to complement the pharmacopeial guidance
for oral dosage forms