We offer help to meet the requirements of the authorities

We are experts in the high demands of the Biopharmaceutical industry

Being compliant is not a fixed state that a biopharmaceutical company finds itself in, as there are often new requirements that the company must adapt to. Compliance can have two meanings, as it is both something the company can do and can become.

A biopharmaceutical company becomes compliant when it complies with a number of different laws, where the number and complexity of the regulatory requirements have increased significantly.  This is done by setting clear guidelines for how compliance must be achieved.

The first step in compliance is for the company to determine which laws fall within the company’s area. The second step is that the company must plan, organize and draw up internal guidelines for how it must be able to comply with these rules. Popularly speaking, compliance is an umbrella term that covers the entire process of how a company handles the rules that apply to it.

AL Engineering A/S has extensive experience in advising biopharmaceutical and biotech companies with the determination and implementation of relevant compliance policies and compliance programs. Whether upstream or downstream AL Engineering A/S has the expertise to give the advice require.

Routine monitoring

By ensuring a good environment in production, a good delivery of high-quality products is ensured. Our experience with controlled environment and cleanroom validation extends from very small cleanrooms with a single sluice, to large complex facilities of several thousand m2 with class B, C, D and CNC, UDF solutions for class A areas above machines, and sluices with PLC interlock systems for separating the different classes. Our specialists have more than 20 years of experience with environmental monitoring and validation of cleanrooms.

Audit (internal and external)

An internal audit is the company's own assessment of the effectiveness of the management system. The more impartial an internal audit is, the greater its value. It can therefore be an advantage to choose a consultant from AL Engineering to carry out an audit, as the result will often be more useful and constructive. In addition to internal GMP audits, we also have extensive experience in planning and carrying out supplier GMP audits on approved critical suppliers and/or business partners both nationally and internationally.

Qualification & Validation

AL Engineering can help define the right validation strategy and ensure implementation and execution. Regardless of whether it is large installations, new equipment or rehabilitation, we can assist with the task. As a starting point, we work in accordance with the IMDRF guideline for process validation. AL Engineering can offer to tailor templates based on best practice from the industry. We can also carry out validation activities according to your quality system (QMS) and wishes. Including design of documents such as validation plan, URS, DS, FAT/SAT, IQ, OQ, PQ IQ, OQ, PQ, RTM, Protocols/test plans and reports.

Compliance EMA & FDA

All organizations that are involved in the development, production and distribution of medical products are responsible for ensuring that they are in compliance with all standards that apply within the EU or US depending on which market the product is marketed. AL Engineering can help draw up internal guidelines according to the legislation and standards that the company must live up to.