Audit Management Software
Pharmaceutical companies place a high value on auditing. Conducting GMP audits in the life sciences industry has the goal of determining whether or not Good Manufacturing Practices are being followed and making recommendations for any required changes. To assist pharmaceutical and biotech companies to improve their quality systems, audit checklists identify weaknesses.
Objectives of Audits in GMP Environment
An audit has been established to be an effective method of assessing GMP compliance with these three quality system objectives:
- Verification of the organization’s control systems and assuring that GMP standards are followed through these controls.
- Identifying possible issues and taking remedial action to remedy them, as well as measures to avoid recurrence.
- Increasing consumer trust in drug products and drug substances and ensuring customer satisfaction.
GMP Audits Types and their Objectives
In the regulated industry, such as pharmaceutical and biotech, there are four types of audits:
Internal audits, customer audits, vendor audits, and regulatory audits carried out by the US FDA, MHRA, and WHO
- Vendor audits are needed to acquire the appropriate raw materials from authorized suppliers in order to ensure drug product realization.
- Stabilize your business by conducting regular assessments of your operations and processes. Internal audits may be used to perform such periodic assessments. The findings of these internal audits are valuable feedback for continual development.
GMP Audits in Life Sciences Industry are conducted in Three Stages:
- Stage 1 – Planning and initiating the audit
- Stage 2 – Conducting the audit in the facility
- Stage 3 – Filing the audit report, identifying corrective and preventive actions, following up, running effectiveness checks, and closing