Pharmaceutical Audit Checklists

In this article

• How Often Does FDA Audit Pharmaceutical Companies?
• Pharmaceutical Audit Checklist For Internal Audits
• Pharmaceutical Audit Checklist For Vendor Audits
• FAQs about Pharmaceutical Audit Checklists
• SafetyCulture (formerly iAuditor) Pharmaceutical Audit Checklists
• Featured Pharmaceutical Checklists

How Often Does FDA Audit Pharmaceutical Companies?

The FDA audits pharmaceutical companies based on the CDER (Center for Drug Evaluation and Research) – ORA (Office of Regulatory Affairs) site selection model (SSM). The 5 main risk-ranking factors to include in a pharmaceutical audit checklist are:

Section A: The compliance history of the establishment

Section B: The record, history, and nature of recalls linked to the establishment

Section C: The inherent risk of the drug manufactured, prepared, propagated, compounded, or processed at the establishment

Section D: The inspection frequency and history of the establishment, including whether the establishment has been inspected in accordance with FDASIA 704 within the last 4 years

Section E: Whether the establishment has been inspected by a foreign government or an agency of a foreign government recognized under FDASIA 712; below are the FDASIA (Safety and Innovation Act) Title VII (Drug and Supply Chain) sections to refer to when choosing a pharmaceutical audit checklist:

• 705: Risk-based Inspection Frequency
• 704: Electronic System for Registration and Listing
• 712: Recognition of Foreign Government Inspections

Section F: Any other criteria deemed necessary and appropriate by the FDA Secretary for purposes of allocating inspection resources

Pharmaceutical Audit Checklist For Internal Audits

Internal audits are key in maintaining and ensuring the efficiency of processes. Aside from providing an unbiased review of operations, internal audits are also used in enforcing compliance with safety and quality standards. This is especially important to pharmaceutical companies as releasing unsafe or ineffective products can lead to lawsuits or fines. To avoid product recall, follow these three simple steps in conducting internal audits:

1. Create an internal audit program

• Use a risk-based audit frequency (similar to FDASIA 705)
• Establish the minimum frequency of audits
• Decide if audits will be based on systems or functions

2. Form an internal audit team

• Enroll potential team members in auditor certification programs
• Ask experienced internal auditors in the team to train new members
• Schedule team meetings to discuss changes in regulation

3. Prepare an internal audit calendar

• Assign internal audit team members to areas independent from them
• Inform internal audit team members about their audit schedules

Pharmaceutical Audit Checklist For Vendor Audits

While the vendor is responsible for ensuring compliance with CGMP for the manufacturing activities it performs, the pharmaceutical company remains responsible for ensuring its products are made in compliance with CGMP. To fulfill this requirement, pharmaceutical companies should follow these five steps when conducting vendor audits:

1. Ensure that the audit team has no connections with the vendor
2. Set the criteria for evaluating the vendor’s quality management system
3. Inform the vendor of when the audit is to be performed
4. Ask the following questions when conducting the audit:

• Can the vendor satisfy government regulations and company standards?
• Is the vendor committed to maintaining quality operations?
• How does the vendor handle its products and data?
• Are there any signs of mismanagement on the part of the vendor?

5. Analyze audit results to determine if the vendor meets the criteria