Pharmaceutical Audit: Scope, Criteria, Methods and Objective

We all know that audit is an important part of any organization, so here we are going to talk about pharmaceutical audits. First, we will start with the scope of the audit. As we move forward, you will learn about its criteria, objectives, methods, and types of audits. So, let’s first start with the scope, and after that, we will discuss each aspect one by one.

Audit Elements:

1. Scope:

The scope is related to the boundary of the audit and its importance. The scope could be entire management system or could be defined using the following broad categories:

• Geographical: particular plant/site, office, or particular region.
• Process: Particular product or service.
• Departmental: Example: purchase activity in this month, logistics in next month, etc.
  (Especially prevalent in first-party audits where an organization will have an annual
  program of individual audits that will eventually cover the entire organization).
• Temporal: time period covered by the audit.

2. Criteria:

What will be the requirements be against which auditee will be examined? Suitable criteria are the key to success of an Audit. Without defining audit criteria, intended outcome of audit may not be achieved. Audit criteria are standards, policies, procedures, or regulatory/statutory/contractual requirements used as a reference against which audit evidence is compared ^(Source). Audit can be a combination of any of the following:

• Combination of standards, e.g. ISO 14001, ISO 45001, ISO 22000, etc.
• Industry or business standards.
• Legal or regulatory requirements, e.g. Health and Safety.
• Contractual requirements, e.g. especially applicable in second-party audits.
• The organization’s own quality manual, its quality policy, and objectives.
• Applicable standards, procedures, management system requirements, contractual requirements, legal requirements, local or international regulatory requirements.

3. Objective:

Objective of the audit is to examine the system that is to determine how well it meets preset audit criteria in terms of conformity, effectiveness, and efficiency and could include opportunities for improvement. Examples include:

1. Determination of the extent of conformity of the management system with audit criteria.
2. Determination of the extent of conformity of activities, processes, and products with the requirements and procedures of the management system.
3. Evaluation of the capability of the management system to ensure compliance with legal and contractual requirements and other requirements to which the organization committed.
4. Identification of areas for potential improvement of the management system.

4. Audit methods:

There are different approaches that can be used in conducting an audit. A description of these particular techniques is available in this annex. All of them are currently in use, and methodological choices are made with regard to the stated audit objectives, scope, and criteria, as well as time and place. The possibilities of the concerned authorities and the factors contributing to the application of the said methods should also be addressed in this aspect. An approach where several methods are used together is more ideal as one is able to maximize efficiency in the performance of the processes of auditing and the end results. The activity of auditing is carried out by people and technology within the organization undergoing audit.

The feasibility of remote audit activities can depend on several factors such as the level of risk to achieving the audit objectives, the level of confidence between auditor and auditee’s QMS/EMS, and regulatory/statutory requirements.

At the level of the audit program, it should be ensured that the use of remote and on-site application of audit methods is suitable and balanced, in order to achieve audit objectives.

Types of Audit Methods:

Based on location, there are two types of Pharmaceutical audit methods:

On-site Audit:

On-site Pharmaceutical audit activities are only done at the auditee location.

Human interaction: This audit method involves interaction with auditee and all queries arising during audit can easily discussed with auditee. This method provides more confidence in achieving audit objectives.

No human interaction: The auditor can work without being influenced by auditee. But if help is needed then auditee can resolve it quickly.

Remote Audit:

Any audit activity can be considered a remote audit when it is carried out arbitrarily other than at the place of the auditee and without any geographical limitations.

Human interaction: Avoids wasting time and finances on traveling. Maybe so that after one medium-length audit, more extended ones can be finished in one day and more audits in a span of time. Non-intrusive, thus no concerns about health and safety, security, and inductions. But also has some disadvantages like problems with reliable interactive communication methods- garbled communications, and timing issues with each other’s speech/listening. Auditors can not properly see the documents shown.

No human interaction: Time can be spent here on serious/detailed planning and review without interruption. Being isolated can help to reach a balanced conclusion. Auditee is free to do their normal job. But also has some disadvantages such as being isolated is not always the best option- especially when auditor is unfamiliar with the organization, its processes, its staff, and its site layout.