Pharmaceutical Audit Checklists

Ensure FDA compliance with digital templates

pharmaceutical audit

Published 29 Sep 2022

What is a Pharmaceutical Checklist?

A pharmaceutical checklist is a powerful tool used to assist drug manufacturers in performing systematic safety and quality audits across their facilities, products, and processes. Performing regular internal or vendor pharmaceutical audits is a proactive approach to identifying and controlling potential risks that are negatively affecting productivity and most importantly, the health and safety of both employees and consumers. It also provides organizations the opportunity to improve operational and production processes.

This article will discuss the following:

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

iAuditor by SafetyCulture Pharmaceutical Audit Checklists

We have published best practice pharmaceutical templates to help you perform self-assessments for Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and general safety inspections.

Get started by downloading these templates using iAuditor – the world’s #1 inspection app. Save hours on inspection times and wasteful data entry. Complete inspections on-site with your mobile device and securely save all your reports in the cloud. 

FAQs about Pharmaceutical Audit Checklists

A pharmaceutical audit checklist must be comprehensive enough to cover the following areas:

  • General QA controls and procedures
  • Facility controls and security
  • Equipment design and placement
  • Material component control
  • Operational control
  • Finished product control

Often, it’s recommended that the time between each pharmaceutical audit must not exceed a 12-month timeframe, or at least once a year. Pharmaceutical companies must conduct regular audits to continuously and constantly monitor the performance of their quality systems.

Preparing for a pharmaceutical audit entails the following steps:

  1. Review documents.
  2. Assign key personnel, such as auditors, and project ownership.
  3. Define audit responsibilities.
  4. Conduct the pharmaceutical audit.
  5. Record findings and recommendations.
  6. Set schedules of follow-ups and necessary actions.
safetyculture content specialist shine colcol

SafetyCulture Content Specialist

Shine Colcol

Shine Colcol is a content writer and researcher for SafetyCulture since 2019, mostly covering topics about health and safety, environmental, and operations management. She is passionate in empowering teams to build a culture of continuous improvement through well-researched and engaging content. Her experience in cross-industry digital publishing helps enrich the quality of information in her articles.

Shine Colcol is a content writer and researcher for SafetyCulture since 2019, mostly covering topics about health and safety, environmental, and operations management. She is passionate in empowering teams to build a culture of continuous improvement through well-researched and engaging content. Her experience in cross-industry digital publishing helps enrich the quality of information in her articles.