Standard Operating Procedures (SOPs) are an integral part of regulatory compliance for any facility that adheres to Good Manufacturing Practices. These documents ensure consistency and accuracy in every step of the production process. Yet, two of the most common reasons manufacturing facilities fail a GMP audit are “lack of documented SOPs” and “failure to follow SOPs”.
Why do so many facilities fall victim to these violations? Though SOPs are essential for regulatory compliance and validation, the process of creating these documents is often hindered by an inability to interpret FDA regulations to match facility procedures, a lack of understanding the specific roles and responsibilities involved in the various production processes, poorly defined task instructions, or burying the details in language that is far too technical and not easy to understand.
In the following article, InstantGMPTM defines SOPs, explains their importance, and demonstrates how the Full PRO Standard Operating Procedures Set from InstantGMPTM makes creating these vital compliance documents easier for manufacturing facilities.
What are SOPs?
Standard Operating Procedures (SOPs) are essentially the step-by-step operating instructions that production facility personnel follow in order to ensure consistency and safety during the production process and the quality of a finished product. SOPs must be created and easily accessible for every task performed in the manufacturing of all regulated biopharma, dietary supplement, pharmaceutical, and herbal products. These active documents must be routinely reviewed to ensure accuracy and revised whenever production processes are adjusted or facilities are updated.
The Importance of SOPs
Standard Operating Procedures are vital to manufacturing facilities in multiple ways. Primarily, they are used as a facility’s foundation for the FDA-required quality system for Good Manufacturing Practices. Additionally, these documents not only provide the necessary instructions for properly performing a task to achieve consistency and quality of a finished product, they also support the training and development of new and existing employees. When properly trained personnel follow the required steps in the production process, it limits the amount of deviations and corrective actions.
Plus, these documents are also necessary for passing audits and inspections. One of the first things an inspector or auditor reviews during their process is a facility’s SOPs. They do so to verify that every task is clearly defined and meticulously followed to adhere to all regulations and compliance.
Difficulties of SOP Creation
Since implementing a quality system for Good Manufacturing Practices is required by the FDA, manufacturers must create SOPs based on the agency’s rules and regulations. Unfortunately, the FDA’s regulations are laid out in very general terms making it difficult for facilities to adapt them for the specific steps of their manufacturing operation. These difficulties often lead to facilities drafting ineffective, poorly defined SOPs or worse abandoning the SOP creation process.
However, there is one extremely helpful tool that allows manufacturers to create the SOPs needed for their quality system: Templates.
Creating SOPs with Templates
Using the FDA regulations as a guide, templates parse the essential information from this source to create a sample SOP outline that manufacturers can easily customize for their specific production process tasks. SOP templates help facilities save time, establish a consistent format, and provide the basic structure for a Quality System.
As helpful as most GMP SOP templates are, they are still limited in their scope. Although these standard templates lead to the creation of final documents, their limitations may result in SOPs that are far from perfect. That’s why InstantGMPTM took the typical SOP template a few steps further to create a more helpful tool.
The Benefits of Full PRO Standard Operating Procedures Set
As the industry’s leaders in Good Manufacturing Practices software solutions, InstantGMPTM looked at the existing SOP templates available to the industry and identified areas for improvement. Instead of offering manufacturers generic templates that do not clearly define the necessary instructions, roles, and responsibilities, InstantGMP’s manufacturing experts interpreted the FDA regulations and guidelines and used them to create 115 highly detailed SOPs that are relevant to the operations of any GMP manufacturing facility.
Using a more active voice and deliberate methodology, InstantGMP’s Full PRO Standard Operating Procedures templates include detailed information that defines the purpose, scope, responsibilities, business requirements, and actions for each specific procedure. Another feature of InstantGMP’s SOP templates that sets it apart from others is a table that identifies each responsible party and the respective action steps they are required to perform.
InstantGMP’s Full PRO Standard Operating Procedures set covers an array of SOP scenarios for facilities, including GMP Site Policies, General SOPs, Quality System SOPs, Material SOPs, Facility and Equipment SOPs, Computer System SOPs, Production SOPs, Labeling and Packaging SOPs, Safety SOPs and more. These 115 SOPs are incredibly helpful for every facility from established pharmaceutical manufacturers that need to update their existing SOPs to start-up dietary supplement manufacturers who have never written an SOP before.
To learn more about how the Full PRO Standard Operating Procedures set from InstantGMP can help your facility, contact us today!