The concept of Standard Operating Procedures
(SOP) was initially used in the U.S. Army to describe a system of military
instructions that allowed the execution of orders in a systematic and
predictable manner. In subsequent years, the concept was implemented into
medical terminology, and now it is used in other fields that require for their
efficiency repetitive but effective instructions that allow rapid achievement
of the desired objective.
But what really is SOP? Practically
speaking, SOP is a system of planned instructions, procedures enabling an
entrepreneur to achieve a certain goal without additional complications. The
SOP should describe in simple steps the next steps of conduct in particular
situations that may occur to employees of various industries. It is important
that the steps are written in a clear and transparent way that does not cause
doubts to those who will have to apply it. Through repetition and detailed
description of important issues, SOP leads to standardization and improvement
of the application of the most complex processes occurring in companies. SOP
system does not only constitute support and facilitation for employees – it
also improves the work of business owners who, thanks to it, have a better
understanding of the processes taking place in entities and are able to more effectively
supervise and respond to operations carried out in companies.
The problem of regulating diligence clauses in employment contracts in the laboratory industry is essential on the basis of Polish and EU law. These issues shall also consider the general consequences of breaching employee obligations in the form of the so-called Good Laboratory Practice (GLP) principles.
For some time in the business turnover we can observe the practice of including in employment contracts clauses concerning professionalism and professional diligence in the actions of future employees. As a rule, the clause at issue imposes an obligation on the employee to perform their tasks in a professional manner, adequate to their position and in accordance with standard operating procedures. In addition, all actions of the prospective employee must conform to the recommendations and directives of the supervisor and comply with the applicable law.
The laboratory industry is no exception in this area. It imposes an obligation on employees and contractors to act not only diligently but also based on the principles of Good Laboratory Practice. These principles have been in place since 1978 and regulate issues such as quality assurance in drug testing and development, the prevention of pharmaceutical scandals, and ensuring performance standards for laboratory areas. In addition, the principles regulate such key issues as staffing, space requirements and the quality of equipment and inspection processes for laboratory areas.
Polish GLP regulation and the consequences of violating it
KG LEGAL Kiełtyka Gładkowski TMT team is participating in The Advertising & Media Summit: The Great Consumer Reset. The event will focus on how consumer engagement and experiences evolve in a post-pandemic world. This latest Accelerate event from CDX will bring together leaders from advertising, media and entertainment, brands, technology, academia, and consumer research. Global consumers have had a full year to modify their behaviors, form new or modified habits for shopping, media consumption, and brand engagement.
The use of AI and machine learning solutions in drug manufacturing technologies with the use of machine learning and quantitative, high-throughput in vivo experiments; the EU regulations for advanced therapy medicinal products (ATMP) and the procedures for placing the most modern drugs on the world market by the European Medicines Agency.
The intensive development of medicine affects the
medical regulatory law in the European Union, which should cover more and more
new legal problems related to the increasingly common application of advanced
solutions of artificial intelligence, machine learning, telemedicine solutions
and cyber solutions to the technology of manufacturing medicinal products.
In the current legal status, however, the legality of
the use of such state-of-the-art AI and machine learning technologies in pharmaceutical
production should be assessed on the basis of the regulations on the assessment
of their final effect, i.e. the level of admissibility of placing ready-made
alternative therapy products on the market, as well as the legal aspects of
commercialization of such technologies.
On May 20, 2021 KG Legal Kiełtyka Gładkowski attended the live webinar “Disputes In Space: Mediate and Arbitrate” organized by ITechLaw organization.
The main topic of the event will be the discussion on resolving customer disputes and issues in a thriving aviation industry. The experts will discuss the issues of out-of-court settlement of disputes in order to work out the most advantageous solution for the client.