The requirements are formulated by the authorities in collaboration with consumers and based on historical experience. Experiences from authorities such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Notified Bodies (medical devices) and national authorities (with country-specific requirements) form together the foundation of the legal regulatory framework. In addition, there may be many requirements included in ISO standards, which are typically used as a template for developing quality systems.
Common to all applicable set of rules is that manufacturers are regularly "tested" against the requirements. At the same time, a large number of partners and suppliers are also being "tested" by the authorities.
These "tests" are referred to as "Inspections", "Audits" or "Certifications". When we talk about inspections and audits, we primarily mean the reviews that the authorities are responsible for, e.g. FDA. These inspections and audits test whether the company meets the specification requirements and authority requirements. For example, there may be requirements to the fluctuation in the amount of ingredients.
Derived from the inspections by the authorities, the companies are subject to requirements for conducting internal inspections (often called internal audits) as well as audits of suppliers with fixed frequency. The authorities expect that the manufacturers will enter into partnerships with their critical suppliers in order to ensure control of the raw materials and thus assure the quality of the final product. It is expected that the company has a multi-year plan for the audit activities required to continue qualifying critical partners.
Thus, inspection and audit activities make up a large part of the resource burden for many companies. Time should be spent on preparation, execution and follow-ups. Specialised competencies must be hired and travel costs must be budgeted. Common to all these elements are that the cost burden for many SMEs is surprisingly high
It is imperative that inspection and audit activities are included in the budget and that things are done right the first time. It prevents companies from being caught napping and ends up with a budget and resource vacuum that can be difficult to come out of.
If you do not manage your processes, or do not comply with applicable requirements, depending on the severity of the non-compliance, authorities and customers may be able to prohibit the sale of given products for shorter or longer periods, and for customers to cease the cooperation.
Ultimately, the authorities can and will withdraw the companies’ manufacturing licenses until compliance is re-established. In some cases, history tells us, that the authorities have demanded the top management dismissed.
If the inspection results show that a product potentially can pose a threat to the patients, you risk not only losing the manufacturing license, but also being required to recall the product(s) already on the market. The consequence of this is overwhelming, as in such cases at least market shares are lost, which can be extremely difficult to regain. Confidence in the company's product quality is compromised and it is quickly rumoured among users at the risk of future sales.
The above worst-case scenario can easily be prevented with the right management approach and the right compliance and quality mindset of everyone in the company. Of course, it starts with the CEO and top management.
The organisation must have the right competences. Resources must be budgeted for securing process optimisations, maintenance and preventive activities. If you fail here, it costs a lot of money to clean up.
At AlfaNordic, we have highly specialised profiles who can assist you with single or life cycle solutions within these disciplines. It can be Lead Auditors and specialists who are prepared with audit expertise and advice.
We make audits with reference to ISO9001: 2015, ISO13485: 2016, ISO22716, Food Legislation (FSSC22000) and cGMP/cGDP and MDR/2017/745