1.
Standard operating procedures (SOPs) are key for operating an efficient Quality Management System. The QMS is mainly based on this procedures. In clinical research, standard operating procedure (SOPs) are defined by the International Conference on Harmonization (ICH) as \”detailed, written instructions to achieve uniformity of the performance of a specific function\”. These standards are necessary for a clinical research organization whether it concerns a pharmaceutical company, a sponsor, a contract research organization, an investigator site, an Ethics Committee or any other party involved in clinical research to achieve maximum safety and efficiency of the performed clinical research Operating. In summary standard operating procedure are the essential ruling processes to ensure that operations are done following regulatory standards and expectations.
2.
Standard Operating Procedure, abbreviation SOP, is widely used but specifically in the manufacture of drug products, APIs (Active Pharmaceutical Ingredients), biologics, devices and the food and cosmetic industry. It contains instructions having the force of a directive, covering those features of operating that lend themselves to a definite or standardized procedure or process without loss of effectiveness. Standard operating procedures, Policies and Procedures can be effective catalysts to drive performance improvement and improving organizational and operating results. Standard operating procedures assure that processes and manufacture will be done in a similar way and lead always to the expected quality of product.
3.
Standard Operating Procedures (SOPs) must be written, approved and followed for any routine operation, activity or task that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient, pharmaceutical product (i.e. drug product) or medical devices to ensure consistent application. In general these procedures should be standardized and systematized. A Standard Operating Procedure is therefore an authorized written procedure, giving instruction for performing operation not necessary to a given product or material but of more general nature. This Standard Operating Procedure than is applicable for all GMP relevant areas within a site or company.
4.
All Standard Operating Procedures must be reviewed and approved by the Quality Assurance (QA) Unit. It is the responsibility of the Quality Assurance to assign a unique number to each SOP. The QA must assure that the current Standard Operating Procedures are distributed and superseded Standard Operating Procedure are retrieved.
5.
The Quality Assurance (QA) is responsible to create, approve and issue the quality system Standard Operating Procedure (SOP). The reconciliation must be documented. The QA is responsible for the retention and the destruction of “invalid” Documents. Functional operating units are responsible that all processes and equipments do have the necessary Standard Operating Procedures in place. It is the responsibility of the functional units to prepare and review these documents. The functional unit managers must assure that SOPs are displayed at appropriate places in their areas. The functional unit managers are responsible that adequate training is performed in sufficient time before a Standard Operating Procedure becomes effective. The successful training must be documented and the trained personnel must sign for the training received.
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