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As a supplier to the pharmaceutical, biopharmaceutical or medical device industry, the documentation must be adapted to the high demands made by the industry. In connection with deliveries, it is expected that you as a supplier can provide detailed documentation that meets international applicable authority requirements according to e.g. GMP and FDA, as well as specific customer requirements in relation to procurement, installation and commissioning.
AL Engineering A/S is a consultancy with more than 20 years of experience within the pharmaceutical industry, biopharmaceutical industry and Medical Devices. We offer specialists with competences within qualification and validation of equipment and facilities who can assist with support for the following tasks:
The validation and qualification process can be a large and very complex part and often requires a lot of resources to perform. We start from your and your customer's organization and work procedures and draw up a plan for the validation/qualification, which ensures an easy and flexible handover of the documentation together with your plant or equipment, and which at the same time meets all authority and customer requirements.
Risk analysis is about identifying any risks and handling them in connection with the implementation of new processes, functions and systems. Based on "best practice" from the industry, we can prepare risk assessments that meet the authorities' expectations for the area. We have detailed knowledge of the analysis techniques FMEA/FMECA and HAZOP and have extensive experience with planning and implementation using the mentioned techniques as well as reporting risk analyses.
Through our experience within the pharmaceutical industry, we can be your partner when protocols and test plans must be prepared according to the specific requirements and standards that must be observed in the pharmaceutical industry. Or you can choose to outsource the qualification and validation part to AL Engineering, and we can be your partner throughout the process, also when the test work has to be carried out. Regardless of the scope, we can ensure that the qualification and validation proceed as planned and that the equipment is put into use on time.
Quality assurance covers all aspects that can have an influence on the quality of the manufactured pharmaceutical product. Depending on a product's purpose and use, there can be a big difference in the level of qualification and validation of both plant and equipment. Our consultants are trained in and have many years of experience in qualifying equipment and plants according to our pharmaceutical customers' quality systems. With our experience, we can ensure that the quality of your plant or equipment is in accordance with a pharmaceutical company's quality assurance system at all times.
AL Engineering A/S
Tuse Næs Vej 7C
DK-4300 Holbæk
Phone +45 59 45 13 68
Email: info@al-engineering.dk
VAT: 25730011