Quality of APIs and Concern for Patient Safety

If the quality of active pharmaceutical ingredient (API) is poor and not up to the prescribed standards, then definitely the impact will be on the efficacy and safety of the finished medications. With this inconsistency, there will be concern over patient safety.

If the results of measured and tested API are inappropriate, then the biggest challenge for a pharma company is the ‘cost of poor quality’.

In fact, there should be a proper assessment of the APIs and raw materials that are either imported or locally procured. It’s only after a thorough testing and evaluation, the presence and levels of defects and/or impurities will be determined.

And to have a desired product quality, it is essential to understand the product in terms of target product profile, and thereafter there must be determination of the significant quality features, which should be within appropriate and safe limits and specifications as per the rigorous guidelines.

It’s certain that deficiencies lead to deviations. So, when production operations fail to meet conformity requirements and expectations, then there’ll be serious quality issues.

Oftentimes, we focus more on productivity levels and speed to market, but deliberately neglect significant considerations such as

• Quality and assessment of APIs,
• Due diligence for cGMP compliance,
• SOPs,
• Inspection of manufacturing sites,
• Efficient CAPA initiatives and 
• Proper investigations.

In one company, most of the staff is aware that there are routine blunders on daily basis. All feel like gossiping others’ lapses, but none takes initiatives to rectify problems. Everyone comes to senses when there’s upcoming audit or inspection and chart out what to do and who shall do as soon as possible.

It’s possible that a pharma company may have an established distributor, but if there is no supplier or manufacturer information, then this may lead to obvious failure to record incoming materials.

To sum up, there needs to be sufficient control over raw materials, finished APIs and vendors.

What happens when a supply chain department considers poorly manufactured or compromised APIs or quality unit fails to evaluate raw materials prior to release and use in manufacturing operations? Plainly, there’s possibility of batch production with particles and contaminants and that may be unsuitable as per specific standards and product requirements.

One lopsided consent may lead to batch failure, and then from destruction to loss.

If at all quality unit fails to be vigilant and carry out review of finished batch production and lab control logs and approves for release of batches for distribution, then there’s lurking danger to patient safety. If any complaint is reported, there’s bad reputation to a company besides the tedious burden of product recalls from the market.

From a progressive viewpoint, with total compliance, a pharma company can ensure safety of patients, regulate quality of its products and demonstrate to customers how responsibly it serves the patient population.

Image source: pharmamanufacturing.com – Caption by Renato Murrer