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 drug manufacturer audit checklist can be used to perform systematic audits of a pharmaceutical manufacturing facility and measure compliance with GMP guidelines. This template assesses six focus areas across:
- General QA controls and procedures;
- Facility controls and security;
- Equipment design and placement;
- Material component control;
- Operational control; and
- Finished product control.
This template has been converted to iAuditor from the ISPE GMP Audit Checklist for Drug Manufacturers, this template should only serve as a guide as to how you can customize your own GMP Audit Checklists.
This article will discuss the following:
- how often does FDA audit pharmaceutical companies;
- how to perform internal audit in a pharmaceutical company;
- how to perform vendor audit in a pharmaceutical company;
- some frequently asked questions about pharmaceutical audit checklists;
- iAuditor pharmaceutical audit checklists.
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
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
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
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:
- Review documents.
- Assign key personnel, such as auditors, and project ownership.
- Define audit responsibilities.
- Conduct the pharmaceutical audit.
- Record findings and recommendations.
- Set schedules of follow-ups and necessary actions.
Featured Pharmaceutical Checklists
This Pharmaceutical Good Distribution Practices (GDP) audit checklist can be used to measure compliance with EU GDP guidelines. This template assesses seven focus areas across:
- quality systems;
- premises and equipment;
- supplier operations;
- complaints and recalls; and
Eliminate paper forms and spreadsheets with this iAuditor digital checklist. Securely perform and store all your templates and audits in the iAuditor app and cloud.
This general facility safety walkthrough checklist can be used to perform general safety checks. It covers safety checks across general areas of aisles, stairs, ladders and air emission points. Take photos of safety hazards using the iAuditor app, take notes and assign corrective actions for immediate follow-up. Download and modify this general template to suit your pharmaceutical warehouse and manufacturing facilities.