Quality Audits in Pharmaceutical
Definition: Audits are conducted to ascertain the validity and reliability of information and to provide an assessment of the internal control of a system. They provide management with information on the efficiency with which the company controls the quality of its processes and products.
Introduction to Quality Audits
In FDA & ISO environments, auditing of both compliance and performance is essential. Pharmaceutical audit experience includes the drafting and revision of validation policies, guidelines and SOP from project qualification to performance evaluation phases. If implemented correctly, it can be one of the most effective means of improvement.
Goals of Quality Audits
The simple goal of this complex process is to evaluate existing activities and documentation and determine if they meet the established standards.
An audit will evaluate the strengths and weaknesses of Quality Control & Quality Assurance processes, the results of which will help us to improve processes and build a better system for the benefit of the company.
Objectives of Quality Audits
- Evaluating conformity of requirements to ISO 9001
- Evaluating conformity of documents to ISO 9001
- Judging conformity of implementation to documentation
- Determining effectiveness in meeting requirements and objectives
- Meeting any contractual or regulatory requirements for auditing
- Providing an opportunity to improve the quality management system
- Permitting registration and inclusion in a list of registered companies
- Qualifying potential suppliers
Types of Quality Audits
1. Internal Audits (First-Party)
Also known as self-audits. Those auditing and those being audited all belong to the same organization. Internal audits are a professional activity that consists of advising organizations on how to achieve their goals in a better way.
2. External Audits (Second-Party)
Customer conducting an audit on a supplier or contractor. Performed to evaluate the competence of contractors where we produce our products or carry out analysis.
3. Regulatory Audits (Third-Party)
Conducted by regulatory agencies (MHRA, USFDA, TGA, MCC, etc.) for compliance or certification purposes. These can be performed without warning and failure may result in restrictions or revocation of licenses.
Audit Objectives by Type
| Audit Type | Main Objectives | Conducted By |
|---|---|---|
| Internal Audits | Assist internal control system, review policies, verify accuracy, detect errors, safeguard assets | Internal audit team |
| External Audits | Develop confidence in partnership, ensure requirements are met, reduce QC testing, reduce risk | Customers on suppliers |
| Regulatory Audits | Ensure GMP compliance, verify license conditions, protect public health | Regulatory agencies (FDA, MHRA, etc.) |
Benefits of Quality Audits
- Managing Quality Management System: Provides systematic approach to quality control
- Early Detection: Identifies weak points through unsatisfactory trends
- Prevention: Prevents quality failures based on data review
- Management Information: Informs senior management about quality levels
- Standardization: Optimizes output and increases audit quality
- Continuous Improvement: Creates improvement loops in processes
- Efficiency: Combining audits reduces audit frequency
- Industry Confidence: Builds mutual confidence between partners
Audit Process and Procedure
10 Steps of the Audit Process:
- Notification: Informing the auditee about the audit
- Planning: Developing audit plan and objectives
- Opening Meeting: Initial meeting with all stakeholders
- Fieldwork: On-site investigation and data collection
- Communication: Regular updates and findings discussion
- Draft Audit Report: Preliminary findings documentation
- Management Response: Auditee's response to findings
- Final Meeting: Conclusion and agreement on findings
- Report Distribution: Formal report distribution
- Feedback: Evaluation and improvement suggestions
Classification of Deficiencies
| Defect Type | Description | Examples |
|---|---|---|
| Critical Defect | High probability of product recall or adverse physiological response | Cross-contamination, incorrect labeling, active ingredients outside specifications |
| Major Defect | Reduces usability or stability without causing consumer harm | Uncalibrated equipment, inadequate segregation, untrained operators |
| Minor Defect | Low probability of affecting product quality or usability | Incomplete records, cleaning schedule delays, documentation errors |
Recording Nonconformities
When recording audit findings, ensure they contain:
- Exact observation: Only facts, reported exactly
- Location: Identify exactly where found
- Description: Clear explanation of what was found
- Reason: Why it is nonconforming
- Evidence: Objective evidence (records, documents, observations)
- Terminology: Use local/industry terminology
- Retrievability: Make it possible to find again
Auditor Responsibilities
- Assist in team selection and inform the team
- Plan and manage all phases of the audit
- Represent the audit team with the auditee
- Control conflicts and manage difficult situations
- Direct and control all meetings
- Make decisions about audit issues
- Report results without delay
- Report critical non-conformances immediately
- Possess effective communication skills
Regulatory Standards and Audits
The ISO published ISO 9000 standards in 1987, boosting interest in quality audits. Today standards such as ISO 9001:2000, ISO 14001:2004, and ISO 13485 require internal audits of quality systems.
FDA regulations including 21 CFR Part 820 (Quality System Regulation for medical devices), 21 CFR Parts 210-211 (CGMP for pharmaceuticals), and 21 CFR Part 606 (blood components) include requirements for regular evaluation of quality standards.
Important: Failure to approve a regulatory audit may result in restrictions or revocation of production or import/export licenses. The FDA has imposed "punitive consensus decrees" on companies that did not adequately respond to audit findings.
