STANDARD OPERATION PROCEDURES IN PHARMACEUTICAL INDUSTRIES

Standard Operating Procedure (SOP) is a?document that provides directions on how tasks and processes should be carried out within a company.

Standard Operating Procedures (SOPs) are an integral part of the routine operations in the pharmaceutical industry and every department has its SOPs.

Having well-defined and well-maintained SOPs helps pharmaceutical companies consistently carry out routine operations, improve process efficiency, have uniform performance, as well as onboard new employees effectively.

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

There are different types of SOPs in the pharmaceutical industry. The SOP type varies depending on the departments, roles, and responsibilities.

The following are some examples of the most common types of SOPs in the pharmaceutical industry:

• Training SOP:?Outlines training procedures, ensuring employees have the necessary knowledge and skills to perform their tasks.
• Safety SOP:?Specifies the steps involved in ensuring the safety of employees and drug products. This includes procedures for handling hazardous materials, as well as procedures for responding to accidents and emergencies.
• Product Distribution SOP:?Governs the distribution and transportation of pharmaceutical products. It ensures proper handling, storage, and documentation throughout the supply chain to maintain product integrity and prevent deviations during distribution.
• Cleaning SOP:?Provides instructions for cleaning and sanitization processes within the pharmaceutical facility. It details cleaning agents, frequencies, and actions to maintain a sterile or non-sterile environment and prevent contamination.
• Production SOP:?Covers the step-by-step procedures for drug manufacturing. It ensures consistency and compliance with GMP requirements, specifying the processes from raw materials to the finished product.
• Equipment Maintenance SOP:?Outlines the steps in maintaining and calibrating critical equipment. This includes procedures for inspecting, testing, and repairing equipment.
• Quality Control SOP:?Defines the steps involved in testing pharmaceutical products to ensure they meet established quality standards and specifications. This includes procedures for sampling, testing, and analyzing products.

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Why Are SOPs Important in the Pharmaceutical Industry?

The main objective of an SOP is to ensure that tasks are performed consistently, correctly and to the required quality standards, which can lead to several benefits for pharmaceutical companies.

The SOPs are important in the pharmaceutical industry because they ensure that drug products are manufactured and handled in a consistent and controlled manner. This helps to reduce the risk of quality issues and non-compliances.

Here are some reasons why SOPs are so important in the pharmaceutical industry.

• Compliance With Regulations

• Ensure Quality and Safety

• Improve Efficiency

• Transfer Knowledge

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What are the SOP Management Guidelines in the Pharmaceutical Industry?

In the pharmaceutical industry, SOP management guidelines encompass the regulations, standards, and requirements that dictate the creation, implementation, and maintenance of SOPs.

Below are some key guidelines applicable to the pharmaceutical industry.

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FDA 21 CFR Part 211

Regulation?21 CFR Part 211?establishes the current Good Manufacturing Practice (cGMP) requirements for finished pharmaceutical products.

It requires pharmaceutical companies to have written SOPs for all aspects of drug manufacturing, including production, testing, and packaging.

Drug manufacturers must create and follow written procedures for production and process control to ensure their drug products have the intended identity, strength, quality, and purity, according to?21 CFR 211.100.

EudraLex Volume 4 GMP

The?EudraLex Volume 4 GMP?contains guidance for interpreting the principles of GMP for manufacturers of medicinal products for human and veterinary use within the EU member states.

It requires companies to have written SOPs for all aspects of pharmaceutical production, from quality control to documentation and personnel training.

Documents containing instructions should be approved, signed, dated, and organized in a clear and easy-to-understand way by authorized persons, as indicated in?EU GMP Chapter 4 Section 4.3.

ICH Q7

The?ICH Q7?provides guidelines and recommendations for the GMP requirements specific to manufacturing Active Pharmaceutical Ingredients (APIs).

Written procedures should be established for several processes, such as equipment maintenance, batch production, customer complaints, change control, and more.

SOPs related to the manufacture of APIs should be prepared, reviewed, approved, and distributed utilizing version control as per?ICH Q7 Section 6.11.

WHO GMP Guideline

The?WHO GMP Guideline?is a framework to aid manufacturers in assessing their planned or existing documents describing their production methods.

It lists different types of SOPs as required documents for demonstrating compliance. The list includes SOPs related to facilities, equipment, production, quality control, quality assurance, and more.

The?WHO GMP Guideline Section 6?states that quality assurance procedures should be in place to ensure that SOPs are enforced and properly used.

The specific guidelines that would apply to a pharmaceutical company will vary depending on the applicable regulatory requirements. It is important to know the applicable requirements to determine the necessary SOP types and their formats.

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SOP Format

An SOP format is a template used to write effective standard operating procedures.

There is no single SOP format that all pharmaceutical companies use. However, some common elements are found in most SOPs.

SOP documents can then be sent through an automated workflow for authoring, review, and approval.

Header

The header includes essential information about the SOP, such as the title, SOP number, version, and effective date.

The information on the header helps identify the SOP and keeps track of its version number.

Purpose

The purpose section states the reason for creating the SOP.

This section defines the specific goals, objectives, or outcomes the procedure aims to achieve.

Scope

The scope outlines the boundaries and limitations of the SOP.

A well-described scope clarifies what the procedure covers and specifies the areas it does not address.

References and Related Documents

This section lists any external documents, regulations, or standards mentioned in the SOP.

A list of references provides sources for additional information and for demonstrating compliance with specific requirements.

Roles and Responsibilities

The roles and responsibilities section defines the individuals or job roles involved in executing the specific processes.

This part of the SOP clarifies who is responsible for each step or task.

Procedure

The procedure section is the core part of the SOP. It provides a comprehensive set of instructions for carrying out the process.

Each step should be clear, concise and in chronological order.

Using active voice, bullet points instead of paragraphs and short sentences are recommended.

Appendices

Appendices contain supplementary information, such as forms, templates, or supporting documents that complement the written standard operating procedure.

Abbreviations

Abbreviation section contains the full forms of all the short terms used throughout the SOP.

Revision History

The revision history lists the changes made to the SOP over time, including the version number, revision date, and a summary of the modifications.

This section helps ensure that employees are working with the most up-to-date SOP version. Providing an overview of how the SOP has developed over time and why specific changes were made.

Signatures

The signatures section contains the names, dates, times and signatures of authorized individuals who have reviewed and approved the SOP. It ensures accountability and authorization.

Typical signatures in 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.
• Authorized by:?The personnel’s signature granting permission for the SOP’s implementation. Usually, departmental heads approve SOP implementation.

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What Are the SOP Management Process Steps?

The SOP management process steps involve a series of actions aimed at creating, implementing, and maintaining standard operating procedures.

The typical SOP management process steps are listed below.

1. Preparation
2. Review
3. Approval
4. Training
5. Implementation
6. Maintenance

1. Preparation

The first step in the SOP management process is to prepare for the creation of an SOP.

This involves identifying the need for an SOP, gathering information about the task that the SOP will describe, and developing a draft procedure.

The specific people who prepare SOPs in a pharmaceutical company will vary depending on the size and complexity of the company. Usually, an SOP writer is an individual who either performs the task or person that is responsible for leading the people doing the job.

2. Review

Once the draft has been developed, it needs to be reviewed by the appropriate people.

This includes the person responsible for checking all the content of the SOP and ensuring that the Scope and the purpose of the SOP are fulfilled.

3. Approval and Authorization

After the review process, the SOP is approved and authorized by responsible personnel who have the authority to sign off on the procedure. This authorization signifies that the SOP is ready for use.

4. Training

Employees are trained on the SOP to ensure they understand the procedures and can follow them correctly. Training is essential to ensure process consistency and compliance with requirements.

Training assignments in the system can include various materials for training, such as training videos, documents to learn, questionnaire to fill and more. All training records are stored in the system so that training can be tracked easily.

5. Implementation

Once approved and the personnel are trained, the SOP is implemented and put into practice.

After implementation, the SOP becomes an official document that guides employees in performing the specified tasks or processes.

6. Maintenance

SOPs are routine documents and may require updates over time due to changes in regulations, processes or best practices. Regular maintenance and revision of SOPs help keep them up-to-date and relevant.

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What Are the Best Practices for Writing an SOP in the Pharmaceutical Industry?

To maintain clarity and accuracy in standard operating procedures, it is essential to follow best practices for SOP writing.

Have a Clear and Concise Scope

The scope of an SOP should be clearly defined at the beginning of the document. This will help ensure that the SOP only covers the specific procedure or process it is intended for.

Use Plain Language

SOPs should be written in plain language that is easy to understand by anyone who needs to use them. Avoid using jargon or technical terms that the reader may not be familiar with.

Be Specific

The SOPs should be as specific as possible. Provide detailed and specific instructions for each step to leave no room for interpretation or ambiguity.

Use Diagrams and Illustrations

Incorporate visual aids like illustrations, flowcharts, and diagrams to supplement the textual descriptions, making complex processes easier to comprehend.

Get Input From Experts

Involve subject matter experts to validate the accuracy and completeness of the SOP, ensuring it reflects the best industry practices.