Lecture 14 Flashcards
What is the difference between Internal Audits, External Audits, and Third-Party Audits?
Internal Audits: Conducted by a company on its own systems to monitor GMP (legal requirement).
External Audits: Performed by a company on its vendors or subcontractors to ensure quality control.
Third-Party Audits: Performed by an independent auditing company to verify a company meets a specific standard.
What are Trace Forward and Trace Back Audits?
Trace Forward Audits: Follow a raw material through the process to determine where it has been used.
Trace Back Audits: Use records to reconstruct the history of a product or process, identifying how it was controlled and used.
What are the tiers of auditors?
Tier One Auditors: Selected based on knowledge, with basic audit training.
Tier Two Auditors: Require more extensive training on quality systems and techniques.
Tier Three Auditors: Specialists with expert knowledge in GMP/GLP and regulatory requirements.
What is a System Audit?
A system audit reviews whether a documented system meets the applicable standard requirements. It can be done by reviewing each clause of the standard and comparing it to the system documentation.
What is a Compliance Audit?
A compliance audit determines whether the documented system is being followed in practice. It involves reviewing operations, paperwork, and comparing them to the system.
Why are audits carried out in a regulated environment?
Audits ensure quality, help assess the effectiveness of QA systems, ensure compliance with GMP/GLP, fulfill legal obligations, and build confidence in vendor partnerships.
What tools does an auditor require?
An auditor needs guides like EU GMP, Orange Guide, pharmacopoeias, previous audit reports, checklists, corporate standards, and a list of areas to audit.
What are the four types of non-conformities in an audit?
Category 1 / Critical: Systemic deficiency that must be corrected before certification.
Category 2 / Major: Breakdown in the system, requiring corrective action.
Category 3 / Other: Isolated non-conformities without systemic cause.
Category 4: Observations needing clarification to improve the quality system.
What is the three-tier approach to auditing?
Tier One: Self-audits by staff on their own section (short and limited).
Tier Two: Audits led by independent local QA groups (longer, systems-focused).
Tier Three: Audits by corporate compliance groups or external consultants to assess regulatory readiness.
What attributes make a good auditor?
A good auditor has relevant qualifications, GLP experience, regulatory knowledge, audit training, and is diplomatic, patient, and a good communicator.
What documentation and information are required before and during an audit?
Before: Gather details on the organization’s size, product quality history, complaints, recalls, and product licenses.
During: Auditors should bring guides (EU GMP), pharmacopoeias, and previous reports, and focus on the 5 Ps: People, Premises, Products, Processes, and Procedures.
