Considering the various departments within a company, one department plays a significant role in each: the quality assurance (QA) department. Quality assurance is the maintenance of a desired level of quality in every stage. QA is the last line of defense for a company, ensuring that the product is leaving the facility at top quality and that all paperwork has been reviewed and approved.  Having a strong QA department is a big key to a company’s success.

For example, production is complete, and the product is now with quality control (QC) for final testing. A member of the QC department recorded the final results but misread the results, which caused the product not to pass specification. The paperwork is now in the hands of QA for review. Let’s take a look at why strong QA support is paramount.

Quality assurance plays many roles in every stage of a company’s procedures and policies—their responsibilities consist of reviewing, inspecting, approving, and assuring compliance.

  • Reviewing – QA should be reviewing the following to make sure everything is compliant and produced correctly. Documents include Batch records, QC data, qualifications, equipment calibration certificates, deviations, CAPA, and other important documents.
  • Approvals – QA has final approvals on all documentation that goes anywhere outside of the company and to the public. QA is the final sign of approval for all products.
  • Compliance – QA is responsible for keeping the entire company in compliance with Good Manufacturing Practices (GMP) under regulatory bodies such as the FDA.
  • Inspecting – QA inspections are necessary to confirm the products are being produced with no defects.
  • Audits – Whether performing an internal audit or handling an FDA audit, QA is responsible and should always be prepared.

Quality Assurance has many different hats within the company and should always be consulted when process and procedures need to be changed. QA can also be split up into different areas such as document control, inspections, audits, documentation, and compliance. When it comes to audits by the FDA or any other agency QA is in control and should always be prepared.

In the example above, the batch record is now in the hands of QA. As it’s being reviewed, it is discovered that the final testing data was entered incorrectly, making the product out of specification and failing final testing. This was a great catch by QA, which otherwise could lead to significant problems for the company. The product could have been given to the public and caused severe side effects, or the FDA could have caught the mistake during an audit, leading to a form 483. Many issues can arise if your QA department is weak – a product that fails testing could be sent out as approved, product labels could be incorrect, equipment goes uncalibrated, and so much more.

The Quality Assurance department is here to help each department stay in regulatory compliance at every stage. QA supports the company as a whole and is there to have the best product come out of the company. PSC Biotech® has highly trained Quality Assurance consultants who can help your company with your quality needs.

Written by Ashley Castro, PSC Biotech® Consultant

Edited by Crystal McClain, PhD

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