Profecta is a player of excellence in the manufacture of self-adhesive labels for the pharmaceutical industry. For this reason, the company has been developing and improving a pharmaceutical program for more than 15 years to ensure that our manufacturing processes comply with the standards of good manufacturing practice.

 

                Good Manufacturing Practices (GMP) ensure that products are always manufactured and controlled to the applicable quality standards for intended use. These good practices enable Profecta to provide a guarantee of the quality of its products and also create a sense of trust with its customers. The requirements of these GMPs are rigorously checked for our quality team. These requirements are applied to premises, equipment, personnel, raw material control, manufacturing control, quality control department, finished product control and records.

 

Premises

                All Profecta premises where products are manufactured and stored are designed, constructed and maintained in such a way as to allow operations to be carried out in a clean, hygienic and orderly manner and to allow the efficient cleaning of all surfaces that are found there. An independent and fenced section also allows for increased control over the production of pharmaceutical grade labels.

 

Equipment

                Profecta uses equipment specifically designed for the production and inspection of pharmaceutical grade labels, and these inspection equipment carries out a 100% inspection of the final product to ensure compliance. Our quality assurance system provides calibration and maintenance of our control equipment in order to preserve their reliability and cleanliness. In addition, this equipment does not contribute to the contamination of products with foreign materials.

 

Personnel

                Our staff has been rigorously trained on the GMP principles. The expertise gained allows us to assign production teams exclusively for our pharmaceutical projects, access to the reserved area for final control is restricted to personal authorized to perform work related to pharmaceutical grade orders.

 

Raw Material Control

                As soon as the raw material is delivered to Profecta, an inspection is carried out to confirm that it is the correct material as well as to confirm that there is no damage on it. The analyzes to validate the functionality characteristics of these materials are carried out by our suppliers.

 

Manufacturing Control, Quality Control and Finished Products Control

                Controls are made throughout the manufacturing stages from the receipt of the order until the final release of the product. Monitoring of controls is done using a checklist specially designed for pharmaceutical grade orders, this document must be followed by all members of the team working on this type of project. We also retain samples at each stage of manufacture to keep product traceability sent to customers.

 

Records

                In order to keep the traceability of the production of each project, all the files are kept. All control documentation as well as the selected samples are archived for a period of 5 years. The identification of pharmaceutical grade records is unique in our ERP system as well as in our physical archives, as soon as the new version of a client's product comes into effect all the elements of the old version of the file are destroyed. This practice allows us to avoid making obsolete versions. The work instructions related to the client files are kept for reference purposes. Our document control system manages the approval of the new versions as well as access to the documentation.