Common Causes of Low Quality in Pharmaceuticals
Common Causes of Low Quality in Pharmaceuticals
Maintaining pharmaceutical quality is critical to ensure safety, efficacy, and regulatory compliance. Low-quality medicines can arise from multiple factors across raw materials, manufacturing, storage, and distribution.
1. Raw Material-Related Causes
-
Use of substandard or contaminated APIs.
-
Poor quality or improperly tested excipients.
-
Variability in raw material suppliers without proper qualification.
-
Lack of proper incoming material testing and sampling.
2. Manufacturing Process Causes
-
Improper mixing, blending, or granulation, leading to non-uniform drug content.
-
Incorrect process parameters (temperature, pressure, coating, drying).
-
Cross-contamination between products or batches.
-
Use of unqualified equipment or poor calibration/maintenance.
-
Inadequate in-process controls during manufacturing.
3. Personnel-Related Causes
-
Lack of proper training in GMP (Good Manufacturing Practices).
-
Negligence or non-compliance with SOPs.
-
Human errors in documentation, weighing, or labeling.
-
Insufficient staffing in quality-critical areas.
4. Quality Control / Quality Assurance Issues
-
Incomplete or incorrect testing of raw materials, intermediates, and finished products.
-
Failure to validate analytical methods.
-
Weak investigation systems for OOS (Out of Specification) or OOT (Out of Trend) results.
-
Poor documentation practices (data integrity failures).
5. Packaging and Storage Causes
-
Use of inappropriate packaging materials (leads to degradation).
-
Poor sealing or labeling errors.
-
Improper storage conditions (temperature, humidity, light exposure).
-
Absence of stability studies or ignoring shelf-life recommendations.
6. Distribution and Supply Chain Issues
-
Temperature excursions during transportation (cold chain failures).
-
Counterfeit or falsified products entering supply chain.
-
Improper handling by distributors or pharmacies.
7. Regulatory and Systemic Failures
-
Weak internal audits and lack of continuous improvement.
-
Non-compliance with GMP / GLP / GCP regulations.
-
Pressure for cost reduction leading to compromise in quality.
-
Lack of robust CAPA (Corrective and Preventive Actions) after deviations.
✅ In summary:
Low pharmaceutical quality often arises due to poor raw materials, inadequate manufacturing controls, human errors, weak QA/QC, poor packaging/storage, and regulatory lapses. A strong Quality Management System (QMS) with robust GMP practices is essential to prevent such failures.
🎓 Discover one of the best Complete Pharmaceutical Production Course available —click below to explore the course that’s shaping future Production Course skills.