Serious Quality Concerns at Manufacturing Operations of Common Pain and Fever Drugs

Serious quality concerns at manufacturing operationsof common pain and fever drugs

Paracetamol (Acetominophen) and Aspirin (Acetyl Salicylic Acid), basic drugs for pains and fever, could face a serious supply shortage due to quality inspection problems at sites of major manufacturers. The entire industry has been looking upon these popular, active ingredients (APIs), as basic commodities for years now. However, it looks like some warning letters are going to disturb the peace which has prevailed in these markets.

French based Novacap’s subsidiary, Novacyl had their aspirin producing facility in Thailand recently receive a warning letter from the FDA. Novacyl produces almost 7,000MT of aspirin at their facilities in Thailand and Saint-Fons in France. In the last three months, this is the second time that Novacyl has been at the receiving end from the FDA as their paracetamol facility in Wuxi, China was cited in late December.

Earlier in the year, India’s large paracetamol manufacturer, Sri Krishna Pharmaceuticals, received a non-compliance report from the Italian Ministry of Health AIFA. The facility, which was inspected, Unit II in Nacharam, produces Paracetamol Direct Compression (DC) granules, and has an installed annual capacity of 3,600MT of DC granules.

The concerns raised in the three manufacturing facilities ranged from:

Investigators found a chromatogram in the trash (Novacyl Wuxi)
Drug products that failed to meet established quality control criteria were not rejected (Sri Krishna)
All CGMP activities were not recorded at the time they were performed (Novacyl Wuxi)
The Master Batch Record had been back-dated by the most responsible persons within the firm (Sri Krishna)
Inadequate controls over access to data raised questions about the authenticity and reliability of the quality of the APIs produced (Novacyl Thailand)
Analysts routinely used the PC administrator privileges to set the time and date to over-write failing and/or undesirable sample results. The practice continued until passing and/or desirable results were achieved (Sri Krishna)

After the FDA inspection in Thailand, which highlighted that they had observed similar data integrity concerns at Novacyl’s Wuxi site, the FDA has recommended that Novacyl management undertake a comprehensive evaluation to ensure compliance.

The concern in Europe was a lot higher since it was recommended that national competent authorities should consider immediate recall of released batches, and prohibition of future supply of Sri Krishna sourced granules.

With global oil prices at record low levels, the cost of sourcing commodity APIs like aspirin and paracetamol was supposed to come down substantially in 2015. However, in view of the failure of established majors to sustain their quality standards, we wonder if the era of commodity APIs is finally over?

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