At ProSys we are dedicated to meeting the strict standards required of the pharmaceutical industry. This is supported by having passed audits performed on our filling lines by several global pharmaceutical companies. We offer a wide range of solutions to meet your pharmaceutical filling requirements by using modern technologies and innovative concepts.
By focusing on laminar airflow around our machines we have supplied filling lines for installation in clean rooms of different classifications for major pharmaceutical companies around the world.
IQ test plan: Contains detailed information of the tests to be performed on the respective equipment in the context of the Installation Qualification.
IQ report: After completion of the Installation Qualification IQ, the results are summarized, evaluated and compiled in an IQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new IQ report.
After a successfully completed Installation Qualification IQ, this is released by the signatures in the qualification report of the persons responsible in the qualification team, countersigned by the user of the equipment, thus completing the process, or releasing the equipment for the next stage of qualification.
OQ test plan: Contains detailed information of the tests to be performed on the respective equipment in the context of the Operation Qualification OQ This test plan contains detailed specifications on the course of the test itself.
OQ report: After completion of the Operation Qualification OQ, the results are summarized, evaluated and compiled in an OQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new OQ report.
After a successfully completed Operation Qualification OQ, this is released by the signatures in the qualification report of the persons responsible in the qualification team, countersigned by the user of the equipment, thus completing the process, or releasing the equipment for use.
Performance qualification (PQ) of laboratory equipment is an important component of the validation of the entire production process over a certain period of time and for a specific product. Its purpose is to verify and document that the systems are working reproducibly within the entire specified working range and limits. The systems are not inspected individually but always as part of the overall or partial process. Even though PQ usually comprises OQ tests under process conditions (e.g. for hot air sterilizers with load), a detailed test plan has to be created based on a comprehensive process description before the validation process is started in any case.
GMP, also known as cGMP, stands for current Good Manufacturing Practices, and is a set of regulations set forth by the U.S. Food and Drug Administration (FDA) to help ensure that various products intended for human consumption and use are safe and effective.
The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "c" in cGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.
Title 21 CFR Part 11 of the Code of Federal Regulations deals with the United States Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).