What are SOPs?

Critical compliance documentation.

A Standard Operating Procedure (SOP) is a document that provides guidelines for the execution of day-to-day operations and processes within a company that essentially captures the when, where, what and by whom those operations are performed.

In the pharmaceutical industry SOPs are not only an essential component of basic operations, they are a regulatory requirement, with each relevant department and area having its own set of SOPs.

Effective SOP management involves the systematic process of creating, implementing, and maintaining these procedures, ensuring that all procedures are appropriately documented, regularly reviewed, and communicated efficiently to relevant personnel.

Well-defined and well-maintained SOPs therefore play a critical role in enabling pharmaceutical companies to streamline their Quality Management System (QMS), allowing them to consistently conduct routine operations, enhance process efficiency, maintain uniform performance, and facilitate the effective onboarding of new employees.

Click here for more information from the EMA on SOPS.

Key reasons for SOPs.

They are a regulatory requirement.

Both the EU and FDA require SOPs as a part of their regulatory requirements and the review of an SOP for a particular process will be the first step in any inspection. If a process or procedure is not executed according to its SOP there is a risk of a warning of non-conformance or deviation.

They maintain consistency.

SOPs ensure consistency throughout a process to ensure results are within an acceptable or absolute tolerance. This is critical across the entire product life cycle, from laboratory, through trials and onto marketing and production. It is easy to see how important SOPs can be for manufacturing and distribution where deviations can destroy batches and lots before they arrive with patients.

They can help improve efficiency.

SOPs allow improvements from their review and update from a known and consistent baseline. This could be in response to changing information, systems, or new manufacturing and storage processes.

They facilitate knowledge transfer and responsibility.

SOPs allow the effective onboarding of employees working at all product life cycle stages, and clearly define who is responsible for which work duties to avoid overlapping.

Typical SOP management process steps.

Preparation – Recognising the necessity for an SOP, collecting pertinent information regarding the task to be outlined in the SOP, and formulating a preliminary procedural document.
Review – Following the development of the initial draft, subjecting it to scrutiny by the relevant individuals or authorities.
Approval – Following the review phase, obtaining approval from personnel with the authority to endorse the procedure. The approval serves as confirmation that the SOP is prepared for training and implementation.
Training – Providing comprehensive training to employees on the SOP before full implementation to ensure a clear understanding of the procedures and the ability to adhere to them accurately.
Implementation – Putting the SOP into effect and integrating it into practical operations.
Maintenance – SOPs are dynamic documents with the potential need for periodic updates due to changes in regulations, processes, or advancements in best practices.

The role of SOP signatures.

Signatures play a crucial role in the Preparation, Review, Approval, and Implementation stages of an SOP. They serve as a means of establishing accountability and authorization by capturing the dates, times, and names of individuals responsible for reviewing and approving the document.

Typical signatures required for the compliance of an SOP include:

Prepared by: The signature of the person responsible for creating the SOP.

Reviewed by: The signature of the individual who reviewed the SOP.

Approved by: The signature of the individual who approved the SOP.

Why choose Aegisana's SOP Creation & Review services?

Our depth of coverage.

Aegisana’s internal teams have extensive expertise in developing effective SOPs, covering a wide range of activities such as Clinical, Post-marketing, Veterinary, Cosmetics, Manufacturing, and Distribution. We are well-equipped to support your requirements in nearly all areas.

The review, improvement, and creation of client SOPs are overseen by either our compliance or pharmacovigilance experts, depending on the specific areas and activities involved.

Additionally, our external safety partners adhere to either client SOPs or the internal SOPs within our own Quality Management System.

The review, improvement, and creation of client SOPs is led by either our compliance and/or our pharmacovigilance experts depending on the areas and activities involved.

Common SOP areas that we support.

Training.
GCP – Clinical Safety.
GVP – Post-marketing Safety.
VGVP – Veterinary.
Cosmetovigilance.
GMP – Production, Quality Control, Cleaning, Equipment Maintenance.
GDP – Product Distribution.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.