Glossary Definition: Standard Operating Procedure (SOP)

A standard operating procedure (SOP) is a set of written instructions that detail how to perform a routine activity. It includes step-by-step guidelines for how to complete a specific process. 

In order to consistently achieve a desired outcome while maintaining integrity and quality, it is crucial for the instructions to be followed exactly as prescribed, every time.

Regulated industries rely on standard operating procedures to maintain compliance.

These industries include but are not limited to: 

• Manufacturing
• Life Sciences
• Semiconductor
• Nuclear
• Warehousing
• Food & Beverage
• Hospitality 
• Education

Additionally, many non-regulated industries such as administration and A&E also use SOPs to reap the many benefits they provide, such as:

SOPs can be referred to by other names, including:

• Work instructions
• Established procedures
• Standing orders
• Standard procedures
• Set form 
• Modus operandi
• Pharmaceutical SOPs

Depending on the industry and individual business, the terms may vary. However, most regulated industries require companies that provide products or services within that industry to abide by SOPs that meet or exceed regulatory guidelines set forth for that specific industry. In this case, they are almost always referred to by the actual term or by the acronym, SOPs.

Standard operating procedures in pharma are tested, verified, approved, and controlled instructions for how to conduct and complete daily pharmaceutical operations.

There isn’t a blanket approach to SOPs in pharma. Instead, each department must define its own set of SOPs based on its unique business, process and regulatory requirements. Pharma SOPs outline step-by-step instructions for how to perform and complete specific job functions or manufacturing tasks.

Pharma companies are required to have SOPs related to:

• Quality Assurance (QA)
• Quality Control (QC)
• Validation
• Production (or Manufacturing)
• Maintenance 
• Computer Systems
• IT and Security
• Environmental, Health & Safety (EHS)
• Personnel, equipment, and material flow

SOPs help determine who is responsible for specific activities as well as the expected outcomes of each process. These guidelines help mitigate communication discrepancies, errors and out of sequence events by clearly outlining how to perform a specific process or task, who should perform it, when they should perform it, and what to expect.

Standard operating procedures are important in pharma because it’s a highly regulated industry that is required to have detailed instructions (aka SOPs) for every process, procedure, and operation.

During an FDA audit, SOPs are part of the documentation needed to complete the inspection. The regulatory auditor will review each department’s SOPs to verify a number of things, such as whether:

• Processes are being followed as outlined
• Processes are up to par with current regulations
• All processes, procedures, and operations have been thoroughly documented
• Staff have been trained on and maintained training at specified and appropriate intervals to ensure they are qualified to perform the actions, tasks or activities within associated SOPs

This is critical because it establishes medication efficacy and guarantees product and personnel safety throughout the preclinical and clinical phases, as well as during commercial manufacturing.

In conclusion, standard operating procedures are a critical component of highly regulated industries such as pharma manufacturing. They help minimize the likelihood of errors by offering step-by-step guidance for how to complete every step of every process, procedure, and operation. As a result, products can be commercialized quicker with fewer errors and greater consistency — without sacrificing quality or safety each and every time a product is manufactured.