Wednesday, 8 November 2017

Ensuring Product Safety & Effectiveness

The Role of Pharmaceutical Quality Assurance in Ensuring Product Safety & Effectiveness

Quality Assurance – A Systematic Approach to Overcoming the Surge of Substandard Medical Products by Edward Simpson


Quality assurance entails all the arrangements made to ensure that pharmaceutical products are safe, effective and have the desired quality according to their intended use. Quality assurance is considered a good manufacturing practice for meeting the standards and specifications of pharmaceutical products in terms of quality, reliability, efficacy and safety. To ensure the safety of public health, standard operating procedures are designed in compliance with scientific regulations and executing the SOPs is the responsibility of the QC department.

Calibration services play a vital role in various aspects of quality assurance right from manufacturing of medical devices to ensuring adherence to product releases. Calibration services ensure compliance with pharmaceutical quality standards for patient safety.

Ensuring Quality on the Floor

The quality assurance unit of highly specialized organizations is responsible for delegating the operations to quality employees who must ensure that the law is complied to and the end-users are protected from the potential accidental defects in the manufacturing process. Every pharmaceutical company knows the risks involved in the mass manufacturing of products for patient use but not many are aware of how to combat these hazards efficiently. Calibration services reduce the risk and improve product safety.

Today medical device manufacturing practices are governed by FDA and ISO and more and more companies are accustomed to the impact of instrument calibration on product liability. This has compelled companies to follow safety oriented procedures and reduce the risks associated with product liability.

Steps Involved in Quality Assurance

Quality assurance is a broad concept that encompasses monitoring and management of production processes, documenting, and analyzing data to maintain product quality
  • QA starts with consulting the program advisor and the technical crew on developing and designing QA measures to fulfill the standards mandated by the regulatory authorities.
  •  Locating calibration services to perform the required external checks Evaluating in-house resources and capabilities to identify the limitations
  • Making recommendations for process improvements that can be implemented over time

The Solution

Professional organizations need to actively cultivate a culture where quality management is the core focus. For this, organizations need to develop a robust training program that efficiently addresses quality management issues and covers technical documentation and reporting obligations for timely investigation of quality issues. Internal and external checks should be performed by quality employees and field technicians at the project sites.

Internal Checks should include the Following Verifications:

  •          The use of de-ionized water for identifying contamination
  •          Filtering of buffered water used for testing results in positive and negative plates
  •          Field duplicates are collected at the same time and at the same place for sampling precision 
  •         Samples are segregated into subsamples before they can be analyzed for precise comparison
  •          The instrument is set to zero using de-ionized water and blanks are employed to check for         drifts.
  •         Instruments are calibrated against multiple standard concentrations of a specific indicator

External checks should be performed by a licensed QC lab while ensuring that:

  •          The duplicated sample collected at the site is analyzed at the same time and at the same place by an independent sampler.
  •         One sample is analyzed by both the project lab and the independent lab and both the results are compared for discrepancies.
  •          All the field duplicates are sent to an independent lab and the results are duly compared with the measurements.
  •          All the labeled samples with known concentrations are sent to the QC lab for analysis before the first run is performed and the results are compared for discrepancies.
  •          For unknown samples, the findings should be compared with known values by an independent QC lab and any discrepancies should be reported.
Pharmaceutical companies that ignore these quality checks are likely to suffer serious consequences. Focusing on compliance is not enough to succeed, companies need calibration services to make sound decisions regarding product quality.

 Quality Assurance V/s Compliance  

While industries have a singular focus on quality, regulatory authorities concentrate on compliance. Both the terms are used interchangeably but there is a considerable difference between the two. Quality assurance entails all the processes and procedures implemented in an organization to ensure high-quality standards that meet regulatory requirements while compliance is a function that simply documents the quality of your manufacturing processes and products. It is possible to ensure quality even without compliance checks but there can be no compliance in the absence of quality. Compliance treats the symptoms of a problem but quality treats the cause itself.

Author Bio: Edward Simpson works for RS Calibration Services and has a knack for finding faults in machines and does not rest until they are rectified to perfection. He lives in Pleasanton, CA and loves to write about how machines work and about the importance of proper care and calibration of equipment. When he's not working or writing, he loves to run to stay fit.