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Standard operating procedures (SOP) - Back Bone of Pharmaceutical Industries

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Abstract

In the face of a challenging regulatory environment, some leading Pharmaceutical companies have found ways to improve quality and costs significantly. To drive this kind of beneficial change, companies must first create a culture where quality objectives are transparent, well understood, and undoubtedly these goals can be achieved by following certain sets of procedures called as “Standard Operating Procedures” (SOP). Procedures are essential for any plant’s effectiveness and efficiency, and they are regulatory requirement in the Pharmaceutical Industry. A typical Pharmaceutical Industry has an average of 1200- 1300 SOPs. A Parenteral Drug Association (PDA) survey found that a typical pharmaceutical company must manage an average of 1250 CGMP-required SOPs and that the average maintenance burden is 15,000 h per firm. A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization. The development and use of SOPs are an integral part of a successful quality system. It provides information to perform a job properly, and consistently in order to achieve pre-determined specification and quality end-result.

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... SOP supports the application of ongoing processes and procedures, so that organizations can avoid inconsistencies and safety risks if personnel changes occur [17]. It is necessary to guarantee the progression of processes to accomplish quality performance and quality products in term of preparations that at certain occasion can take much consideration in term of financial and human resources as well simulation process [18]. If there are errors in the final SOP, such as printing quality issues, typographical errors in term of color and shape, incorrect page numbers or misaligned sentences, or errors that do not affect the scope of the procedure, they may be immediately reprinted correctly. ...
... SOPs should be prepared with full adherence to guidelines and organizations and reflect current organizational practices [19]. Ideally, the SOP should include some or all of the following: those who do the work, those who maintain the equipment related to the SOP, the engineers or others who design the equipment or processes, the technical initiators, Safety officer, environmental officer, equipment manufacturer [18]. Placing value only on production, ignoring safety, health and the environment, is ultimately expensive. ...
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