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.
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
PSC Software Solutions
PSC Biotech Services provide fast, budget-friendly, high-level expertise.
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