Quality Assurance & Audit

We are experts in quality assurance

AL Engineering A/S is a consultancy with over 100 years combined experience within pharmaceutical and biopharmaceutical industries

We offer specialists with competences within quality assurance who can assist with support for the following tasks:

Quality assurance

Our consultants can provide support in connection with inspection, GAP analyses, review of cGMP documents, cause analyzes and treatment of CAPAs, etc. We have experience with the purchase of process and laboratory equipment as well as qualification and preparation of documentation (URS, IQ, OQ, PQ) and test protocols. Our experience helps to ensure that the quality is in accordance with GMP at all times.

Production support

We have extensive experience in supporting production departments with tasks that ensure a later QA approval of the production - i.e. we prepare deviations, examine all types of documents, write SOPs and ensure that qualifications/validations are carried out correctly in terms of quality.

Audits

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.