Quality assurance representatives play the following important roles in the pharmaceutical industry: –
– Review and approve all documents: Reviewing all documents and having them approved by Quality Assurance ensures that all documents and their contents are controlled by Quality Assurance to ensure that the contents of the documents only change in a controlled manner.

– Internal and external audits: Internal audit to ensure that the system is effectively implemented in each department of the pharmaceutical manufacturing site.
External audits are usually required to ensure that suppliers supplying raw materials, services, etc. have a quality system in place so that the occurrence of quality problems is minimized.
In some cases, after a quality problem is reported, Quality Assurance may conduct an external audit to determine the root causes and ensure whether or not the seller has taken the necessary protective and preventive measures.

– Investigation of quality complaints: In the case of quality-related complaints, the quality assurance representatives are responsible for determining the root causes together with the appropriate persons inside and outside the production site.

– Corrective and Preventive Actions (CAPA): Development and implementation of corrective and preventive actions that enable effective application of quality systems and avoid recurrence of past equality problems.

– Training: One of the measures to ensure quality is to train staff to avoid non-compliance and consider this as a proactive measure to maintain the quality system.

– Compliance: This ensures that all processes at the production site comply with the rules of Good Manufacturing Practice (GMP) (example: In Process Control or IPC).

According to the above roles, Quality Assurance Managers must have the skills and experience to perform all of the above critical and essential roles in the pharmaceutical industry to ensure the production of safe, effective and stable medicines.

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