Standard operating procedure and its implementation

For the pharmaceutical industry, the buzzword is GMP and its implementation at all levels to ensure product quality. Product quality is the main responsibility of the Quality unit, which comprises the Quality Control and Quality Assurance laboratory. The quality of the product is the responsibility of all the personnel involved in its manufacture, analysis, launch or distribution to the market.

For the pharmaceutical industry, GMP implementation is ensured by following standard operating procedures for the procurement, testing, production, and release and distribution of manufactured products. In the pharmaceutical industry, success and sustainability depend on the company’s ability to continuously learn and update its knowledge base in accordance with the changing global requirements of health authorities and the needs of customers. They achieve this mainly through continuous learning, training and the effective implementation of knowledge through the use of various Good Manufacturing Practices (GMP) starting from the acquisition of the material, testing and release of the material, production of the desired pharmaceutical product, its packaging and market launch and successful distribution, followed by effective handling of customer comments and complaints with corrective and preventive actions. In GMP implementation, good documentation with data integrity is of the utmost importance. To accomplish this, various tools in the form of manpower, machines, and methods are utilized through the use of standard operating procedures (SOPs) written in simple instructional language.

For the pharmaceutical industry, SOPs are important and mandatory to meet the requirements of various regulatory authorities and achieve the quality of the manufactured product along with its performance. The SOP understood the purpose and scope that defines the requirement and the application of the SOP; responsibilities of the personnel involved; references to guidelines or other information and SOPs, policies; written procedure as simple active voice instructions and SOP annexes and history. The SOP can be as small as one page or as large as 120 pages or more. The SOP is a very simple tool, which when used by a person, allows them to obtain the desired results. Any deviation during the SOP follow-up may affect the outcome of the procedure. Therefore, although the standard operating procedures are simple to implement, it is necessary to provide the required training to the personnel involved.

SOPs must be easily accessible to users and must be kept up-to-date, in accordance with regulatory requirements and customer or user requirements. For ease of documentation, pharmaceutical SOPs are classified into different categories, including user departments, for example, production, raw material warehouses, finished goods warehouses, human resources department, engineering and maintenance department, control laboratory of quality, quality assurance department and the marketing and finance departments. The SOP must be written by the real user or executor of the activity and reviewed by his superior or the head of department. And then these must be approved by the quality assurance personnel considering the totality of the defined activity and its impact on quality, considering the regulatory requirements and those of the current clients.

The simplicity of SOPs and the effectiveness of training and their implementation is the key to the success of the company in its journey towards constant customer satisfaction and market regulations and achievements.