Pharmaceutical Audit Illustration

Guide to Quality Audits in the Pharmaceutical Industry

by | Apr 28, 2022 | Audits, Pharmaceutical

Quality audits are crucial to ensure compliance with regulatory requirements in any industry. Similarly, quality audits are conducted in the pharmaceutical industry to ensure that the complex system of processes and operations of your pharmaceutical company meets industry standards.

Let us take the example of metformin (the most commonly used prescription for type 2 diabetes) that your pharmaceutical company is planning to manufacture and sell in a new market. It is only based on regular quality audits that you, the regulatory agencies, and the public, will have the assurance that this product is safe and efficacious for use.

Quality audits can be daunting, but by understanding what will be audited, having accurate documentation, and preparing for questions from the auditor, you can make the process less stressful and more efficient.

This article introduces pharmaceutical audits and offers tips on how to prepare for them.

We will look at the following in more detail:

What Is a Pharmaceutical Quality Audit?

A pharmaceutical quality audit is a systematic and independent examination wherein you will establish whether the activities that your company performs are compliant with standard regulations. You will also determine whether they are effectively implemented to achieve the required objectives.

Quality audits, whether internal or external, are essential to a good pharmaceutical quality management system. With the help of quality audits, your pharmaceutical company will effectively evaluate compliance with regulatory requirements and get the required feedback, which is needed for improvement.

With the help of the SimplerQMS audit management software solution, you can significantly reduce the time and effort needed to pass audits by automating audit-related tasks, such as document routing, data collection, notifications, approvals, and escalation of activities.

Types of Audits in the Pharmaceutical Industry

In general, your pharmaceutical company will face three types of quality audits:

  • Internal audits
  • External audits
  • Unannounced audits

Internal Audits

As a pharmaceutical company, you will audit your facilities, systems, and standard operating procedures (SOPs) under a process called internal auditing. These audits are conducted regularly, and you must have procedures and programs available for conducting such audits.

Depending on the complexity of the internal auditing process, it can be categorized into multiple categories:

  • Tier 1
  • Tier 2
  • Tier 3

Using an audit management solution, you can facilitate planned internal audit activities by managing audit schedules, creating regular assignments, setting due dates, and automatically sending out notifications to the right people at the right time.

Tier 1 Internal Audits

These audits are the least complex of the internal audits. They are conducted by personnel of the concerned department or section.

These audits are normally of short duration, are frequent, and concentrate on issues such as auditing the housekeeping or documentation of a particular department or section.

For example, personnel in the manufacturing section may audit the thorough cleaning of all scoops, vessels, and sieves used there.

Even for tier 1 auditing, the personnel assigned to do the auditing need to have received basic training before auditing.

Tier 2 Internal Audits

Tier 2 internal audits are more complex when compared to tier 1 internal audits. They focus more on the system and the frequency is less when compared to tier 1 audits.

For example, this could include auditing the purity of the products developed by the R&D department constitutes a tier 2 example.

These audits, by their nature, will be of longer duration, and the auditors need to have rigorous training with an emphasis on the quality systems and techniques. Also, the auditors will be personnel independent of the concerned department or section.

Tier 3 Internal Audits

Tier 3 internal audits are the most complex and least frequent of the internal audits.

They can be carried out to assess the readiness of the pharmaceutical company for a forthcoming regulatory audit. Additionally, tier 3 internal audits may be conducted before beginning a crucial activity within the company.

For example, if your company is going to start manufacturing metformin for the first time, a tier 3 internal audit is advocated.

The auditors for tier 3 internal audits need to be highly trained with the necessary expertise and knowledge of all regulatory requirements in the pharmaceutical industry.

You can also bring in external consultants to do these types of audits. If you are interested in learning more about how to choose the right consultant, we suggest reading the article on the key areas when selecting a pharmaceutical consultant.

External Audits

External audits are also referred to as second and third-party audits.

Second-Party Audits

Second-party audits are conducted by parties interested in the audited company.

They could be both customers and suppliers.

Supplier audits come under second-party audits because as a manufacturer, you must know your supplier(s) thoroughly.

Let us take the example of metformin. The active ingredient is metformin hydrochloride, along with various inactive substances such as cellulose acetate, magnesium stearate, and others.

You will want to do a supplier audit of the vendor supplying metformin hydrochloride before manufacturing metformin. This is needed to reduce any potential risks, ensure vendor compliance and knowledge, confidence in supplier agreements, and increase efficiency.

With integrated audit management capabilities like SimpleQMS you can also manage relevant information derived from supplier audits, and other supplier-related activities such as deviations, non-conformance reports, supplier corrective action requests (SCARs), CAPAs, and quality information in one centralized location.

Recommended Reading: The Simple Guide to Supplier Qualification in Life Sciences

Third-Party Audits

Third-party audits are conducted by external independent organizations, such as notified bodies or authorities.

Regulatory audits conducted by regulatory agencies also come under third-party audits. For example, national regulatory bodies such as the Medicine Control Agencies (MCA) of the UK and the US FDA will mandatorily conduct third-party audits.

In addition, regulatory bodies of one country may audit manufacturers based in other countries. For example, the FDA will audit your manufacturing plant located in Europe, if you are supplying medicines in the US.

It should be highlighted that third-party regulatory inspectors are comprehensively trained and highly knowledgeable.

Unannounced Audits

Manufacturers of pharmaceutical products are subject to random unannounced audits by regulatory agencies. Such audits can also include your third-party vendors who supply crucial raw materials for your products (i.e., unannounced supplier audits).

Such audits are carried out both in the European Union and the US, usually with some months of notice to allow for scheduling and traveling.

The frequency of such audits depends on the complexity of the products that you manufacture and may be anywhere between 3 to 5 years.

Major Pharmaceutical Audits

The major pharmaceutical audits that your company will face can be grouped under internal and external audits.

Major Internal Audits

EU GMPs 1.4 (xvii) states that:

“The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that (xvii) there is a procedure for self inspection and/or quality audit which regularly appraises the effectiveness and applicability of the quality assurance system.”

ICH Q7 D. Internal Audits (Self Inspection) (2.4) states that:

“To verify compliance with the principles of GMP for APIs, regular internal audits should be performed in accordance with an approved schedule. Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. Agreed corrective actions should be completed in a timely and effective manner.”

Your pharmaceutical company should perform regular internal audits in accordance with an approved schedule. These internal audits will check the effectiveness of your QMS and document all audit findings.

If necessary, agreed corrective actions should be completed in a timely and effective manner.

External Audits

EU GMPs 7.5 states that:

“The Contract Giver is responsible for assessing the competence of the Contract Acceptor to carry out successfully the work required and for ensuring by means of the contract that the principles and guidelines of GMP as interpreted in this Guide are followed.”

Before outsourcing to a third-party vendor, your company needs to assess the legality, suitability, and competence of the vendor. You will also ensure that the vendor diligently follows the principles and guidelines of GMP.

Directive 2004/27/EC (19) states that:

“The quality of medicinal products for human use manufactured or available in the Community should be guaranteed by requiring that the active substances used in their composition comply with the principles of good manufacturing practice in relation to those medicinal products. It has proved necessary to reinforce the Community provisions on inspections and to compile a Community register of the results of those inspections.”

Your pharmaceutical company will ensure the quality of the products you manufacture by ensuring that the active substances used in their manufacture and manufactured in accordance with GMP.

SimplerQMS audit management software helps you comply with various regulatory requirements applicable to internal and external quality audits for organizations in the pharmaceutical industry.

Ways in Which Pharmaceutical Audits Are Conducted

There are three ways in which pharmaceutical audits are conducted:

  • On-site audits
  • Remote audits
  • Self-audits

Let’s discuss each one in more detail.

On-Site Audits

As the name suggests, during the on-site audit, the concerned regulatory agencies will come to your company and will review all documents, tour the company’s premises, interview your staff, and verify that your pharmaceutical company meets all regulatory requirements.

Let us look at the example of metformin that your company wants to sell in a new market. The regulatory agency of that country will make an on-site audit and ensure that you have met all necessary regulatory requirements.

Remote Audits

As we know, the COVID-19 pandemic has upended life. It has put a lot of restrictions on both individuals and companies alike. However, one of the plus points has been a renewed interest in remote auditing.

Remote auditing is like on-site auditing regarding the document review, staff interviews, tour of your manufacturing sites, etc. The difference is that the regulatory agency will connect with you virtually using different types of technology.

Your organization will need to use various tools for file sharing, video conferencing, screen sharing, and/or Electronic Quality Management System (eQMS), like SimplerQMS, to share and review the required documents with the regulatory agencies.

To learn more about remote auditing, check out our guide on remote auditing best practices.


Self-audits are also called internal audits. As discussed before, your pharmaceutical company will conduct internal audits regularly as part of complying with regulatory standards.

These audits are valuable exercises that ensure that the documents and QMS of your company are efficiently and effectively maintained. You should ensure that self-audits are conducted by staff who are not directly involved with the audited matters.

Let us revisit the metformin example. When you start marketing this drug, you will need to conduct regular self-audits to ensure that the medication is manufactured as per documented and planned protocols. This will ensure its safety and efficacy.

What Does a Pharmaceutical Audit Examine?

The quality audits that your pharmaceutical company will undergo will assure the regulatory agencies and public at large that your organization is compliant with all the necessary requirements.

By looking at the typical ways in which audits are conducted, we will get a better understanding of what pharmaceutical audits examine.

On-Site Audits

During on-site audits, some of the typical questions that the regulatory inspectors will ask your company are as follows:

  • Do the pharmaceutical facility and the various departments of your company operate under a state of control?
  • Does the QA department of your pharmaceutical company review all production records routinely to ensure that protocols and procedures are followed and documented properly?
  • Is there sufficient equipment, laboratory space, and qualified personnel on hand?
  • Are all QA procedures approved?
  • Are all production batch records and release test results first reviewed for completeness and accuracy before the release of a batch of finished products?

Remote Audits

Remote audits are similar to on-site audits, except that they are virtually conducted.

This includes a virtual tour of the entire facility. Other areas/processes that are typically audited during the remote audit include the review of documents, protocols, and policies.


During the self-auditing process, the personnel selected to conduct this will typically ask the following questions:

  • Are the personnel working in the sterile filling area properly trained?
  • Are all protocols and procedures up-to-date and authorized?
  • Is there any cross-contamination of raw materials or finished products?
  • Are the warehouses cleaned according to schedule?
  • Are all batch record entries duly filled and signed?

How to Prepare for a Pharmaceutical Audit?

The key points that your pharmaceutical company needs to focus on while preparing for an audit are as follows.

Review All Documents

First of all, you will need to review documents from past audits.

Based on this, you will next need to prepare a detailed list of all relevant documents, including, but not limited to:

  • Batch records
  • Master formula records
  • Standard operation protocols
  • Change controls
  • Deviations

These documents must be reviewed to ensure that they are validated and current. Also, ensure that all supporting documents and records are available.

It is at this stage wherein an efficient QMS software with robust document control capabilities such as SimplerQMS becomes most useful. All documents are digitized and automatically named, numbered, and versioned, following best practices of pharmaceutical document management. This will help you ensure compliance with the relevant standards and regulations of your industry.

Select Personnel and Delegate Responsibilities

You will need to select one or more individuals from every department as key people for the forthcoming audit.

The responsibilities for the various aspects of the audit will be delegated amongst them.

This personnel will have the requisite knowledge about the auditing, documents, records, systems, and protocols in place.

Prepare an Audit Plan

The third step in your plan of action is for the selected personnel to prepare an audit plan which outlines the flow of the audit.

This plan of action will be provided to the auditing inspectors.

With the SimplerQMS audit management solution, you can group all the upcoming audits under an audit plan and collect all the important details, including title, scope, objective, criteria, auditors, location, and others.

At this point, you need to note the strengths and weaknesses of the various departments. Ensure that the strongest departments are focused first, to highlight the strengths of your company.

Conduct an Internal Audit

The next logical step is to conduct an internal audit.

This will ensure that all relevant personnel is confident and that any loopholes are fixed. You may consider bringing in external experts for this part of the auditing process.

Be Prepared for Remote Audits

The COVID-19 pandemic has shown that remote auditing is here to stay.

Be prepared for remote auditing with file sharing, video conferencing, screen sharing, and an efficient eQMS solution.

10 Tips to Help You Make Auditing Smooth

1. Make sure that you and all key personnel are available on the day of the audit.

2. Make available a separate room for the use of the auditor.

3. You should be on time to meet the auditor and not the other way around.

4. Maintain a very high level of professionalism through auditing. Questions, etc, should be directed at the auditor in a polite, professional manner.

5. Take detailed notes of the entire auditing.

6. Answer all the auditor’s questions honestly. Remember not to volunteer additional information.

7. Provide only copies of documents, not the originals.

8. Never leave the auditor alone with your documents or records.

9. Have an exit interview with the auditor at the end of the auditing process.

10. As soon as the audit is completed, start preparing your arguments for any discrepancies or problems highlighted by the auditor.

Pharmaceutical Audit Management Software Solution

If your pharmaceutical company is still using paper-based systems and processes, there are limitations and challenges that you are likely to face regularly.

Recording on paper-based systems is a lengthy process. At times, the information may no longer be relevant at the time it is transcribed.

Documentation errors can lead to regulatory non-compliance. This can prove to be costly for the company in terms of brand name, time, and money.

With the help of the SimplerQMS audit management software solution, you will save the time and effort that is needed to successfully pass your audits.

The system automates audit-related activities so that you can reduce the time and effort needed to successfully pass audits.

With SimplerQMS, you can easily collect documents and reports across the product life cycle, in a single location. This makes it easy to share information with external partners. The system also allows you to easily link a response such as a nonconformance, supplier corrective action request (SCAR), or CAPA. This makes it easy to track and resolve quality issues.

Final Thoughts

Quality audits in the pharmaceutical industry are essential to ensure compliance with regulatory requirements and give confidence to the public that your products are of the best quality and efficacy.

When you invest in an efficient eQMS such as SimplerQMS, you will save both time and effort with the entire auditing process. You will find that it’s much easier to ensure regulatory complaince and will benefit from a host of other features.

Book a demo today and talk to our experts to see how we can help you streamline your audit management process and help you work more efficiently with your documentation.

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