Application of Statistical Quality Control Tools for Monitoring of Pharmaceutical Product Properties

Abstract

Pharmaceutical dosage forms are unique products that should meet the highest possible quality standards as they impact the health of the final consumers directly.Safety, identity, strength, purity and quality (SISPQ) are integral properties that should be embedded into the dosage forms through proper implementation of good practices reference guidelines (G´P).The current study was aimed to monitor and inspect the quality characteristics of the sustained release capsule product viz: average filling weight, potency determination, dissolution profile, bulk and finished product yield to ensure stability of the pharmaceutical properties of the product and to spot areas of possible improvements provisionally.Statistical process control (SPC) showed that there were intermittent states of out-of-control (OOC) in each monitored properties, although none of the batches showed out-of-specification (OOS) results.Compliance to GxP including good manufacturing practice (GMP) and good laboratory practice (GLP) is important to ensure consistent and predictable performance of the manufacturing process parameter of the product.

Cite this work

No public copy is stored for this record, so only the metadata is cited.

Stored only when both papers are in the corpus — 5 citations exist upstream.

Papers that cite the same references — the relational fallback while embeddings are still backfilling.