Standard Operating Procedure and Its Implementation

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

For the Pharmaceutical Industry, the GMP implementation is ensured by following the Standard Operating Procedures for the procurement, testing, production and release and distribution of the products manufactured. In the pharmaceutical industry, success and sustainability depend on the ability of the company to continuously learn and update their knowledge base as per the changing global requirements of the health authorities and customer needs. This they achieve mainly through the continuous learning, training and effective implementation of the knowledge by using various Good Manufacturing Practices (GMP) starting from the procurement of the material, testing and release of the material, production of the desired pharmaceutical product, its packaging and release in the market and successful distribution, followed by effective handling of the customer feedback and complaints with corrective and preventive actions. In the GMP implementation, good documentation with data integrity is of utmost importance. To achieve this various tools in the form of manpower, machines, methods are used by using the Standard Operating Procedures (SOPs) written in the simple instructive language.

For the Pharmaceutical industry, SOPs are important and a must to meet the requirements of various regulatory authorities and to achieve the quality of the product manufactured along with its yield. The SOP comprises of the purpose and scope defining the requirement and application of the SOP; responsibilities of the personnel involved; references to the guidelines or other information and SOPs, policies; procedure written as simple instructions in active voice and the attachments and history of the SOP. The SOP can be as small as one page or as large as a hundred and twenty pages or more. The SOP is a very simple tool, which when used by a person, allows them to obtain the desired results. Any deviations while following the SOP may affect the outcome of the procedure. Hence, although the SOPs are simple to implement, it is necessary to provide the required training to the personnel involved.

The SOPs should be easily accessible to the users and need to be maintained up to date, in line with the regulatory requirements and the requirements of the client or user. For the ease of documentation, the pharmaceutical SOPs are categorized into different categories, including the user departments, for example, production, raw material stores, finished goods stores, human resource department, engineering, and maintenance department, Quality control laboratory, Quality assurance department and the marketing and finance departments. The SOP needs to be written by the actual user or performer of the activity and reviewed by his senior or the department head. And then these need to be approved by the quality assurance personnel considering the totality of the activity defined and its impact on the quality, considering the current regulatory and customer requirements.

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