A regulatory inspection by the local competent health authority is a critical event that can have a significant impact on ongoing operations and is designed to indicate the level of quality, safety, and efficacy of the products manufactured by a pharmaceutical company. The inspections are each government’s way of ensuring that the medicines produced, imported, or distributed by that company are safe, effective, and of high quality for the patients who use them. Regulatory inspections will be conducted at regular intervals by health authorities, such as the US Food and Drug Administration (FDA), here in Ireland by the HPRA, or in the UK by the MHRA. They aim to determine if the company complies with the applicable laws, regulations, and guidelines.
A health authority inspection can be routine or can be triggered by an event, such as a complaint, a recall, or a serious adverse event. In any case, the inspection itself can be stressful and challenging for the company being inspected. This is particularly true if major deficiencies or non-compliance are revealed, which can lead to warning letters, fines, sanctions, or even product withdrawals.
It is crucial therefore for pharmaceutical companies to be fully prepared for regulatory inspections and to be able to demonstrate processes that are in control, methods and procedures that are compliant and products that are safe. To achieve this, conducting a thorough mock inspection beforehand is one of the most effective methods.
A mock inspection is a practice run of a regulatory inspection, which imitates the process, scope, and objectives of a real inspection. It is most usually conducted by senior quality staff or external consultants who possess experience and expertise in regulatory affairs and quality assurance.
A mock inspection can help the company to:
- Identify and correct gaps or weaknesses in the pharmaceutical quality system, processes, procedures, documentation, and records.
- Evaluate and improve readiness and performance in responding to inspectors’ questions, requests, and observations.
- Train and coach, its staff on how to interact with inspectors in a professional and confident manner.
- Evaluate and improve the organisation’s commitment to quality and compliance.
- Minimize the possibility of unfavourable results and conclusions during the inspection process.
A mock inspection can be conducted at any time, but it is especially recommended in the months leading up to the actual or anticipated regulatory inspection.
When conducting a mock inspection, it is important to thoroughly assess all relevant aspects of the company’s operations. This includes examining the quality management system, organization and personnel, facilities and equipment, materials management, production and process control, packaging and labelling, laboratory control, validation, change control, deviation management, complaint handling, recall management, adverse event reporting, product stability, and data integrity.
So what are the differences between a mock inspection and a regular audit?
A mock inspection and a supplier or quality systems audit are both methods of evaluating the compliance and quality of the company in question, but they have some differences.
A mock inspection will attempt to simulate a real competent health authority inspection (e.g., FDA/HPRA) and is more often conducted by specialists with the aim of preparing the company for the upcoming inspection. They will assess the company against the specific directives or federal codes within the scope of the company’s licenced operations. Whereas a supplier or quality systems audit will be a systematic and independent examination of the company’s quality system by a member of the audit team of a prospective customer or their appointed consultants to determine whether the company conforms to pre-defined criteria and will instead tend to focus on specific products and services that are to be provided by the company rather than directives or federal codes.
In order to be ready for a real inspection, it’s important to conduct a fair, unbiased, and constructive mock inspection. During the mock inspection, it’s crucial for the inspectors to provide honest feedback and recommendations for the company to improve. The company should take the mock inspection seriously and be ready to take prompt corrective actions.
Although a mock inspection does not guarantee success in the actual inspection, it is an excellent chance to learn from errors, enhance performance, and boost confidence. A pharmaceutical company can achieve its quality objectives and enhance product safety and efficacy for patients and public health by conducting a mock inspection. By using a consultancy company to help them prepare for a regulatory inspection, a pharma company can benefit from the expertise, experience, and perspective of the consultants, and increase their chances of passing the inspection with minimal or no findings. This can save time, money, and reputation for the pharma company, and ensure that their product or process meets the regulatory standards and expectations.
Sometimes lean organisations just do not have the capacity to handle all their audit or mock inspection requirements and will leverage outside organisations and contractors to help facilitate some or most of their audit and assessment programs. Selecting the right partners is critical, and we can help you with this.
Here at Orion Consulting we have built a team of GXP audit professionals with a vast breadth of experience in GMP inspections and audits of global active pharmaceutical ingredients and finished dose manufacturing sites across the world. We also have experience in managing bespoke audit requirements to assess technology transfer capabilities, manufacturing technologies, or to carry out an initial assessment or mock inspection of sites to GMP, GLP, GCP and GDP regulations.
For each assessment, we work with our clients to discuss their individual needs, review the company or site to be assessed and determine the capabilities to be assessed and regulatory standards to be applied. We then work with our client to ensure the audit is booked and to identify the best auditor for the type of assessment.
We can work closely to identify the right expert for your audit requirements, whether supplier assessments, storage sites, testing laboratories or internal or external manufacturing sites.
If you need an immediate assessment of your audit program or have a critical or urgent audit that you need to address then, please contact us at: info@oriongxp.com or phone +353 07198 10101