How to avoid quality disaster in Pharmaceutical Companys?

How to Avoid a Quality Disaster?

“Cascade of failures.” That was the FDA (Food and Drug Administration) inspector’s description in a recent case for a pharmaceutical company’s quality unit. FDA inspected their manufacturing facilities multiple times in 2022 and 2023 and several quality observations were issued by FDA as Form 483. From lack of quality oversight to destroying critical production documents on the day of inspection, it is the textbook definition of a quality disaster. What can we learn from these and other recent red flag cases to avoid more quality disasters?

Strong Quality Culture Starting with Senior Executives:

A pharmaceutical company must always remember its mission and live it daily: producing life-saving medicines. The moment the focus becomes a profit-only company, the quality of medicine produced drops as cost-cutting measures are implemented to squeeze the maximum profit possible. Quality culture starts from the top. Senior executives are not only responsible for the quality of medicine but should also empower and set an example for the company to have a quality culture of ensuring high-quality medicine. There must be a culture of transparent communication where employees will be protected or even rewarded for reporting any concerns or potential issues that could impact product quality and patient safety. It should be a culture where every company stakeholder has the confidence to hand the medicine produced by the company to their loved ones.

Establish Strong Quality Management Systems (QMS):

Control and oversight of the pharmaceutical product quality is essential. Without a quality management system, having an oversight of the quality is impossible. Regardless of whether paper-based or digital, it is crucial that there is a strong quality management system where there is a clear quality overview of all pharmaceutical operations from R&D to manufacturing and distribution. This also includes defining corrective and preventive actions (CAPAs) and timelines for their implementation. A strong quality management system also has a robust change control process where any changes, deviations, and OOX (OOS and OOT) events to the established process, equipment, or system are evaluated for their potential impact on product quality and patient safety. A strong QMS also includes the following areas:

  • Risk management: Potential risks that could impact product quality, patient safety, and compliance should be identified, assessed, and mitigated according to the severity, probability, and detectability of the impact. A regular review of the risk should be done to ensure a good oversight of risk management.
  • Record management: One critical aspect of strong QMS is accurate and organized documentation of all the processes and activities which includes standard operating procedures (SOPs), protocols, reports, and batch records. Change and version control are essential to good record management.
  • Data integrity: Appropriate controls and procedures should be implemented to prevent alteration of data and unauthorized access.
  • Validation and qualification: Critical processes, equipment, and systems should be validated and qualified to ensure that they consistently perform according to the intended use.
  • Supplier management: Suppliers should be thoroughly evaluated and qualified to ensure that they meet the required quality standards. Leveraging the supplier’s QMS is beneficial to ensure the balance of quality and efficiency.
  • Regular internal audit and inspection: Drug manufacturing can be messy at times when production is under pressure. However, it is not an excuse to have contamination or low-quality drugs. Internal audit and self-inspection at least once a year allow any potential non-compliance issues to be identified and addressed even before inspection from the regulatory agency.
  • Regular training: Education is not a one-time event. cGMP-related topics should be re-trained yearly regardless of how long an employee has been working in the company. It helps maintain a high compliance awareness and quality standard adherence.
  • Regular maintenance: Prevention is better than cure. It is much better to maintain the equipment, device, and facility regularly to prevent any impact on the drug’s safety and efficacy.


Engage Qualified Consultants:

If a strong quality culture and QMS are too overwhelming, consider hiring experienced consultants such as the GxP-CC team who specialize in pharmaceutical regulations to navigate through compliance challenges so that you can focus on producing safe and effective drugs.



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