Cases

Below you can read about some of our previous cases in different contexts.

PRODUCTION SUPPORT IN ENVIRONMENTAL MONITORING

Purpose: Planning routine sampling, reviewing results and preparing trend reports.

For this task, we used our experience from extensive cleanroom validations according to Danish, European and American (FDA) requirements carried out for some of the country’s largest pharmaceutical companies.

It was our consultants’ task to analyze the routine measurements, decide on deviations and prepare trend reports.

Result: Approved trend reports and possibly deviation reports.

SOP WRITING FOR A NEWLY ESTABLISHED MEDICINAL FACTORY

Purpose: Plan and write SOPs for a newly established pharmaceutical factory

Within the process area utility, upstream and downstream, it was the task of our professional and experienced specialists to create SOPs that described the approved procedure that is routinely carried out in a GMP facility for the pharmaceutical company in question.

SOPs were drawn up in accordance with GMP within the three areas such as described how alarms should be handled and the equipment should be operated and operated.

Result: All necessary SOPs written and approved by QA within the set deadline

DESIGN CONTROL ANALYSIS FORM THE BASIS FOR PROCESS VALIDATIONS

Purpose: AL Engineering was contacted by a development department at a customer in relation to assistance in analyzing the compliance level around design control for one of their products. The documentation for the design of this product was compared with, among other things, ISO13485:2016 and ISO14971:2012, during which relevant stakeholders from the customer’s development and quality assurance functions were consulted.

Result: The analysis itself was documented in a report that was presented to relevant people and decision makers. The result of the analysis gave an overview of the state of design control and the links to process validations, which gave the customer a new/revised basis for process validations in their production of Medical Devices.

PROCESS VALIDATION LEADED TO OPTIMIZATION OF VALIDATIONS

Purpose: In connection with AL Engineering’s consultants being hired for assistance with process validation at a customer, our consultants identified that the number of validations could be optimized and reduced without compromising the compliance level.

Result: The experiences were discussed in the customer’s organization and the result was that the number of validations was actually reduced.