EAS independent consultant, Heidi Stuttz discussed how writing effective SOPs can influence compliance and build a better organization in Drug Development Delivery. Drug firms must devote time, diligence, and meticulousness in the development of safe product design, materials sourcing, manufacturing, and quality control. Additionally, SOPs are an important part of primary documentation requirements under good manufacturing practices (GMPs).
STANDARD OPERATING PROCEDURES – How Writing an Effective SOP Can Influence Compliance & Build a Better Organization
Heidi Stuttz, EAS Independent Consultant
INTRODUCTION
When it comes to developing internal procedures, drug firms must devote time, diligence, and meticulousness in the development of a safe product design, materials sourcing, manufacturing, and quality control. Per the Food and Drug Administration (FDA) regulations, standard operating procedures (SOPs) are an important part of the primary documentation requirements under good manufacturing practices (GMPs), and they must be in place to successfully navigate an FDA inspection.
It is important to note the FDA has no requirement for what constitutes an SOP or how it should be formatted, yet one of the first items a consultant or FDA auditor will request is a list of SOPs for the system or subject area in question. SOPs are expected to be written clearly, concisely, and easy to follow. They are the driving force behind every activity in your organization. A well written SOP is essential to compliance and business efficiency. Writing a clear and concise SOP should not be a task taken lightly and its development, when done properly, can be more detailed and complicated than initially imagined. An SOP can provide subjective evidence that your company is organized and has the instructions for your employees to carry out tasks in a consistent, compliant manner.
THE TEMPLATE
Creating a template with a framework of expectations is a simple, yet effective way to drive compliance in your organization. This template should lay the groundwork for expectations across the various departments in your organization. Templates support alignment, provide an opportunity for consistency, and promote an environment in which everyone can follow instructions in a consistent manner.
The following summarizes a common outline used in many companies and will explore the essential elements of a well written SOP. This template will be effective whether developing an SOP from scratch or remediating a current system of SOPs and will foster success in every area of your company in which it is implemented.
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Posted in Drugs, EAS in Action.