AUDIT COMPLIANCE REPORT MASTER FORMULA THAT WAS NOT APPROVED

During the WHO GMP inspection conducted at the AABBCC pharmaceutical manufacturing facility, the following observation was raised:

“Master Formula that was not approved.”

The objective of this investigation is to determine the root cause of the audit observation regarding the use/availability of a master formula that was not approved by the Quality Assurance Department prior to implementation. The investigation aims to assess the impact on product quality, regulatory compliance, documentation practices, and GMP requirements and to establish appropriate corrective and preventive actions (CAPA) to prevent recurrence. The inspection team observed the following deficiencies:

This investigation covers:

• Review of the observed Master Formula document.
• Assessment of document control practices.
• Evaluation of batch manufacturing records associated with the Master Formula.
• Review of approval workflow between the Production and Quality Assurance departments.
• Assessment of product batches manufactured using the concerned master formula.
• Evaluation of compliance with applicable GMP requirements and internal procedures.
• Determination of potential impact on product quality, patient safety, and regulatory compliance.

This observation indicates weakness in the monitoring and continuous improvement elements of the pharmaceutical quality system