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 consists of a quality control and quality assurance laboratory. Product quality is the responsibility of all personnel involved in its manufacture, analysis, release or market distribution.
For the pharmaceutical industry, implementation of good manufacturing practices is ensured by following standard operating procedures for purchasing, testing, producing, issuing, and distributing manufactured products. In the pharmaceutical industry, success and sustainability depend on a company’s ability to continuously learn and update its knowledge base in accordance with the changing global demands of health authorities and customer needs. They mainly achieve this through continuous learning, training and effective implementation of knowledge through the use of various Good Manufacturing Practices (GMP) from material procurement, material testing and release, production of the required pharmaceutical product, packaging and release to market and successful distribution, followed by effective handling of customer feedback and complaints through corrective and preventive actions. In implementing GMP, good documentation along with data integrity is of utmost importance. To achieve these various tools in the form of manpower, machines and methods are used using Standard Operating Procedures (SOPs) written in simple prescriptive language.
For the pharmaceutical industry, standard operating procedures are important and must meet the requirements of various regulatory authorities and to achieve the quality of the manufactured product along with its yield. The SOP consists of the purpose and scope that define the requirements and application of the SOP; responsibilities of the personnel involved; references to guidelines or other information, standard operating procedures and policies; Written procedure as simple instructions with active voice, attachments and history of the SOP. An SOP can be as small as one page or as large as a hundred and twenty pages or more. SOP is a very simple tool that, when someone uses it, allows them to get the desired results. Any deviations while following the SOP may affect the outcome of the procedure. Hence, although SOPs are easy to implement, it is essential to provide the required training to the personnel involved.
SOPs must be readily available to users and must be kept up to date in line with regulatory requirements and customer or user requirements. For ease of documentation, pharmaceutical SOPs are categorized into different categories, including user departments, for example, production, raw material stores, finished goods stores, human resources department, engineering and maintenance department, quality control laboratory, quality assurance department, and marketing and finance department. the SOP It needs to be written by the actual user or performer of the activity and reviewed by their senior or department head. Hence it must be approved by QA staff considering the entirety of the specific activity and its impact on quality, taking into account existing regulatory and customer requirements.
The simplicity of standard operating procedures and the effectiveness of training and its implementation are key to the company’s success in its journey towards consistent customer satisfaction, organizational satisfaction and market achievement.