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SOP Management in Pharmaceutical Industry

by | May 16, 2022 | Pharmaceutical

Standard Operating Procedures (SOPs) are an integral part of the day-to-day operations in the pharmaceutical industry, and every department must have its own SOPs.

It is against regulatory requirements to execute operations without a properly developed, approved, and controlled SOP.

The best way to ensure safe and compliant operations is to implement Standard Operating Procedures (SOPs). SOPs provide a framework for each department within the organization to follow when conducting daily activities, and they can be used as a training tool for new employees.

This article will look at the definition of SOPs and their importance in the pharmaceutical industry. This article will also explore various types of SOPs, their format, and the role of using digital software for managing SOPs.

Jump to sections:

What is a Pharmaceutical SOP?

Pharmaceutical Standard Operating Procedure (SOP) is a tested, verified, approved, and documented way of executing operations that form the pharmaceutical industry’s basis. It provides step-by-step guidance for the personnel to perform a specific process.

For example, pharmaceutical finished products are sterilized according to the approved SOP, i.e., sterilization time and temperature for every product type are defined in the SOP.

The ultimate purpose of SOP is to streamline the Pharmaceutical Quality Management System (QMS) that contributes to the overall product quality, and safety.

Some examples of day-to-day operations that involve SOPs include, but are not limited to:

  • SOP for orientation of the new employee
  • SOP for preventive maintenance of a packaging machine
  • SOP for batch manufacturing in the production department
  • SOP for operating process machinery such as blister machine, filling machine, and labeling machine

Using an all-in-one pharmaceutical QMS software by SimplerQMS gives a centralized and secure repository for all your SOPs. This makes search and retrieval of all the necessary documents much easier, especially during audits and inspections when gathering any current documents on demand.

Why SOPs Are Important in the Pharmaceutical Industry?

SOPs in the pharmaceutical industry serve many purposes and are as crucial as other essentials such as equipment and personnel.

Every critical process, procedure, and operation must have its SOP, and it is against regulatory requirements for them to be executed or initiated without its SOP.

Let’s look at some of the main reasons why SOPs are so important in the pharmaceutical industry.

It Is a Regulatory Requirement

Various standardization and regulatory bodies such as EU GMP and FDA require Standard Operating Procedures (SOPs) as a part of their regulatory requirements.

During their process inspection, they start by first reviewing the SOP for that particular process.

They inspect whether the process or procedure has its SOP and whether the process is executed according to the SOP. They can issue a warning or non-conformance if there is no SOP or there is a deviation between executed process and the approved SOP.

Ensures Consistent Results

SOPs are rigorously tested and verified for accuracy by relevant personnel.

If it passes acceptance criteria, only then are they implemented in the production process.

The SOP testing and verification activity help produce consistent results for every manufacturing process, batch or lot.

It also prevents deviations from standard results and helps prevent failure.

Recommended Reading: Guide to Deviation Management Process

Improves Efficiency

SOPs are constantly updated in response to changing process requirements or due to the latest trends. It helps increase the efficiency of a pharmaceutical process in the most beneficial, effective, and proven way.

Provides Accurate Delegation of Staff Responsibility

Staff responsibility is clearly defined and explained in the SOP, enabling the departmental supervisor to depute specific personnel for a particular job.

It prevents overlapping of responsibilities and helps in an effective delegation of duties.

SimplerQMS software solution gives complete control over your SOP management processes, making it easy to create, update, track SOPs, and ensure regulatory compliance.

What Are the Different Types of SOPs in the Pharmaceutical Industry?

EU GMP and 21 CFR part 211 provide manufacturing guidelines for Europe and the United States, respectively. Every pharmaceutical manufacturer who intends to manufacture or sell products in these markets must comply with their requirements.

These bodies also guide the creation of SOPs in line with their requirements.

According to these organizations, there are various types of SOPs, including the following.

FDA 21 CFR Part 211

FDA 21 CFR Part 211.160 – General Requirements states that the quality control unit must approve the establishment of laboratory procedures or controls, and any deviations must be appropriately recorded or justified. Additionally, calibration of associated instruments, gauges, and other recording devices must be carried out per an established written procedure.

FDA 21 CFR Part 211 Subpart F – Production and Process Controls states that there shall be written procedures to ensure identity, strength, quality, and purity in drug products. The written procedures must be drafted, reviewed, and approved by the relevant department, with final approval from the quality control unit.

FDA 21 CFR Part 211.56 – Sanitation indicates written procedures for responsibilities of sanitation of buildings and facilities, including cleaning schedules, methods, equipment, and cleaning materials. These procedures must be applied to full-time employees, temporary employees, and external contractors hired to perform the job of sanitation.

EU GMP

Standard Operating Procedures (SOPs) are also mentioned in the EU GMP.

More specifically, Chapter 4 (section 4.29) of EU GMP describes some SOPs that can be used as a reference which is mentioned below.

  • Validation and qualification of processes, equipment, and systems
  • Equipment Assembly and Calibration
  • Technology transfer
  • Maintenance, cleaning, and sanitation
  • Investigations into deviations and non-conformances
  • Environmental Monitoring
  • Recalls
  • Change Controls
  • Supplier Audits

Recommended Reading: What are Current Good Manufacturing Practices (cGMP)?

World Health Organization

World Health Organization (WHO) is also an important regulator in pharmaceutical and medical health and is chartered to operate worldwide by the United Nations.

The guideline “WHO guide to good manufacturing practice (GMP) requirements – Appendix 1” mentions SOP as an essential requirement for its accreditation.

There are more than 75 SOPs in the WHO guideline.

These SOPs are divided into:

  • Raw Materials
  • Biological Products
  • Facility
  • Equipment (production & QC)
  • Production
  • Packaging
  • Quality Control
  • Quality Assurance

SOP Format

There is no fixed format or structure for SOP, and every individual organization decides on its own.

However, some sections must be included in every SOP for their effectiveness and easy understanding.

Let’s look at one common SOP format.

SOP Format Illustration

Header

The header is the SOP’s top section, which gives essential information about the SOP.

Examples of such information include Title, department, and revision number.

Purpose

This section indicates the reason for creating an SOP and describes why it is necessary to create this particular SOP.

Scope

This section defines the SOP limits and describes what purpose this particular SOP will be used.

It can include processes, departments, or personnel.

References and Related Documents

It describes any source of information or inspiration used in the preparation of SOP.

It is indicated for cross-referencing in the later stages of the SOP implementation.

For example, a machine manual is taken into consideration when creating an SOP for machine maintenance.

Roles and Responsibilities

This section indicates the list of concerned personnel responsible for implementing the SOP.

Procedure

This section details all the necessary steps to execute a process.

The procedure should use clear and simple language to avoid any confusion.

Consider using active voice, bullet points instead of paragraphs, and avoid long sentences.

Appendices

It contains the list of all appendices that are being used with the SOP.

Revision History

It indicates the number of times the SOP has been updated.

It is commonly indicated by abbreviations comprising letters, numbers, or alphanumeric series.

Signatures

This section includes the signature of all the concerned personnel directly involved in preparing the SOP.

Common signatures include:

  • Prepared by: includes the signature of the person who has prepared the SOP.
  • Approved by: includes the signature of who has reviewed the SOP.
  • Authorized by: includes the signature of the personnel that allowed the implementation of SOP. Commonly departmental heads authorize the implementation of SOPs.

An SOP format might differ depending on which industry a company operates in. Most SOPs include the sections mentioned above such as the header, purpose, scope, references, responsibilities, procedure, appendices, and revision history.

The customizable templates/forms within SimplerQMS allow you to create SOP templates that suit the needs of your organization.

Effective SOP Management Process Steps

Conventionally, SOPs are managed manually, where each SOP undergoes extensive paper-based work, chasing signature and rigorous follow-ups.

A better approach is to use modern QMS software with robust document control features like SimplerQMS. It takes control of all the SOP functions, from creation to approvals and finally to distribution. It enables you to focus more on process and effectiveness.

Let’s go through the main steps of the SOP management process and see how QMS software makes these processes more efficient.

Initiation

An SOP is initiated when there is a change or addition of a new process in the existing process. 

An example could include the addition of a new packaging machine.

This will trigger an SOP preparation, and the Quality department will not allow production until the relevant department prepares and approve the SOP for operating the machine.

With SimplerQMS, you can easily create SOPs based on customizable document templates. This provides the flexibility to accommodate the needs of each department within your organization.

Preparation

Thereafter, the relevant department prepares the SOP by utilizing all the needed resources and expertise. As mentioned above, SOP must be realistic rather than depending on idealistic assumptions.

With the SimplerQMS solution for document control, it’s easier to prepare and revise SOPs because the system provides an inter-departmental collaboration that allows a user to see other people’s input. This way there is no need for duplicate work or efforts lost in translation between departments!

Approvals

After preparation, SOPs are sent for approval. First, the departmental head approves.

If they are satisfied with the contents of the SOP, then the SOP is forwarded for approval from higher management. Typically, the Quality head gives the final approval, and then it is allowed to be implemented and used.

By using SimplerQMS, you can utilize automated workflows for document authoring, review, and approval processes. The system always notifies relevant employees when they are assigned a task such as a document review or approval, and provides an option to escalate overdue tasks to a manager.

Implementation

When the relevant authorizations approve, the initiator department can start implementing them.

Again, SimplerQMS automatically notifies the initiator department when relevant personnel authorizes the SOP, allowing them to start implementing them and never miss an important assignment again.

Training

Before final implementation, the quality department trains the department for effective implementation.

Training is executed to make sure that every department member understands the SOP’s purpose, contents, and importance. It also helps the personnel to use the SOP according to the organization’s policies.

SimplerQMS solution seamlessly integrates with the training management system. It automatically sends notifications and reminders to the right personnel every time new trainable SOPs, instructions, documents, and/or videos are released. Plus, management can easily monitor which employees have completed training.

Maintenance

SOPs are not created and used for an indefinite time. Instead, each SOP must be regularly reviewed.

During this time, each SOP is reviewed and analyzed to see whether the current SOP stands relevant to the ongoing process, current regulatory requirements, or any change resulting from process improvement.

If the SOP stands relevant, the SOP continues to remain.

Otherwise, it is updated according to the current needs and requirements.

SimplerQMS allows you to review SOP within a user-defined time, such as annually or quarterly. It automatically sends notifications to relevant personnel whenever the user-defined review time arrives.

Tips for Writing and Updating a Pharmaceutical SOP

An SOP describes an actual way of executing a pharmaceutical process or procedure that must produce actual and accurate results.

If the SOP does not serve this purpose, it will lead to unnecessary documentation and, at the same time, may result in non-compliance during regulatory inspections.

Below are some tips for writing an SOP that will lead to a better process and success during pharmaceutical audits.

Familiarize Yourself With the Approved SOP Format

The format for SOP must be approved, and every department must follow it without creating a format of its own.

Before starting to write the SOP, familiarize yourself with the approved format.

This will help you in collecting the required information before finalizing the SOP.

Ensure That Expert Is Involved in SOP Preparation

The relevant personnel or the expert should involve in SOP preparation.

This will help create a practical, applicable SOP rather than idealistic assumptions.

For example, if the SOP is about inspecting glass vials or ampoules, personnel from the inspection department must prepare the SOP.

Be Clear When Writing SOPs

Do not use difficult words.

Instead, every person with basic process knowledge should be able to understand the SOP.

Always use an active voice, and present tense. Avoid including information that is not necessary.

Use Graphical Representation

Multiple decisions are always confusing, and due to the critical nature of pharmaceutical processes. 

To avoid such confusion and prevent erratic decisions in the process, use graphical representation when multiple decisions are possible.

Always Complete SOPs With Relevant Signature

Always complete the SOP with relevant signatures. An SOP is not considered complete if left unsigned.

During the audit, it is highly likely that inspectors can issue a warning or non-conformance if SOPs are without relevant signatures.

By using the SimplerQMS solution, you can let internal and external stakeholders sign documents with 21 CFR Part 11 compliant electronic signatures. This means you can manage electronically and avoid using paper.

More Efficient and Effective SOP Management With a Digital System

SimplerQMS software solution provides a great tool to handle all your SOP-related processes, function, and more.

It eliminates all issues and problems such as unsigned SOPs, outdated SOPs, and incomplete SOPs, and ensures timely distribution to all stakeholders.

Pharmaceutical QMS software by SimplerQMS streamlines the data collection processes and helps ensure that no data is left behind. The system automates SOP management processes such as data collection, task assignments, scheduling, follow-ups, as well as creation, review, approval, and escalation of document-based processes. It sends notifications and/or reminders for training when new SOPs are released and become part of the process in your pharmaceutical organization.

With SimplerQMS, your pharmaceutical organization can easily track SOPs, view the revision history, and have them all readily available during an audit or inspection.

Final Thoughts

Every pharmaceutical organization must have experts that can create accurate process-driven SOPs in line with relevant regulatory regulations.

However, to this day, organizations face challenges in managing and controlling the SOP process.

Organizations try to tackle these problems by increasing the workforce, resulting in mismanagement and problems.

A practical and proven approach is to use an all-in-one QMS software solution like SimplerQMS. It helps you perform all the SOP-related activities and allow you to keep the focus on the process rather than being stuck in data collection, documentation, signatures, approvals, and worrying about audits.

If you are interested in learning more about how SimplerQMS can help you streamline your SOP management activities, we recommend you book a tailored demo today and talk to our system experts.

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