In the pharmaceutical industry, Standard Operating Procedures (SOPs) provide the foundation for efficiency and success for a company. SOPs allow a pharmaceutical company to follow the regulations set forth by the FDA (Federal Drug Administration), as well as the laws put in place to uphold quality assurance and control.
The documentation of pharmaceutical procedures allows for the standardization of vital processes, including sanitation, cleaning, and maintenance of equipment, production and process control, sampling and testing, etc. Documentation is also needed to keep all this information accessible and organized. Any inadequate documentation of these procedures can be extremely costly for a pharmaceutical company. In particular, a lack of well-documented SOPs can result in a loss of product. This in turn can cause potential danger to the public, FDA fines, and litigation.
In efforts to avoid FDA penalties, market setbacks, and harm to potential consumers, technical writers are a vital resource in creating precise SOPs. Technical writers have the necessary skill set to produce documentation that outlines all aspects needed in standard operating procedures as required by the FDA. Additionally, technical knowledge and the ability to translate difficult material into clear, precise information ensures that readers can understand and make use of SOPs. A technical writer helps ensure the development of written policies that are easily understood and followed.
The Purpose of SOPs
At its core, SOPs are guides that meticulously detail all steps for a procedure that employees must follow. This will ensure employees know how to complete their jobs successfully. Through this, SOPs provide such benefits as improving quality assurance and consistency, training new employees, and helping to reduce mistakes in the manufacturing process, among a myriad of others. In addition, in the pharmaceutical industry, these written procedures help employees achieve other tasks required by the FDA.
Without adequate documentation of these procedures, a pharmaceutical company may become vulnerable to product recalls and governmentally imposed penalties, which can deeply affect public confidence in a company’s products. Unfortunately, the lack of proper written documentation is one of the most common regulatory compliance issues that plague the pharmaceutical industry.
A solution to this issue lies in developing clear and concise documentation of SOPs. Highly technical procedures may be difficult for employees if they are vague or too complex to follow. Straightforward SOPs permit employees to carry out their tasks confidently. This lessens the chance of errors occurring, saving the company money and ensuring consistent product quality. As previously mentioned, technical writers help significantly with this, as they specialize in making complicated information more easily understandable.
Benefits of SOPs
SOPs provide several benefits to pharmaceutical businesses. First off, they give pharmaceutical workers a consistent source of guidance and information on how to perform their duties. Through SOPs, important information about tasks or duties can be preserved and taught to new employees even if the original performer of that task leaves the company. In addition, standard operating procedures provide a degree of order and organization to a business. When workers have the information needed to know what they are supposed to do and how to do it, a business’s operations will run much more smoothly.
SOPs and FDA Regulations
Under the FDA’s Code of Federal Regulations Title 21, the FDA stipulates that pharmaceutical companies must have written production and process control procedures. This confirms that their products have the identity, strength, quality, and purity stated by the company. SOPs fulfill the role of such production and process control procedures. These written procedures are vital for the use of employees to complete procedures, including but not limited to the following:
- Responsibilities and procedures of the quality control unit
- Sanitation procedures
- Sampling and testing of in-process materials and drug products
- Prevention of microbiological contamination of drug products purporting to be sterile, including validation of any sterilization processes.
- Proper performance of automatic, mechanical, and electronic equipment
- System for reprocessing batches that do not conform to standards or specifications to ensure that reprocessed batches work with all established standards, specifications, and characteristics
- Testing and release for distribution
In addition, each of these procedures needs professional documentation. They also need to be updated periodically. The extensive documentation required for compliance with FDA regulations can be a difficult task. However, it is necessary for all pharmaceutical companies. Including technical writers, they have the know-how to develop and update SOPs to comply with FDA regulations.
The Consequences of Inadequate Documentation
The FDA conducts inspections of pharmaceutical manufacturing companies to ensure they adhere to good manufacturing practices. However, if FDA inspectors find any potential regulatory violations during the inspection, they may issue a Form 483. This form will flag the system to escalate an FDA warning letter of severe violations. Additionally, rectifying the violation(s) covered by Form 483 and warning letters can be costly. This could cost the company anywhere from hundreds of thousands of dollars to millions.
Furthermore, these violations may take months of fixing and testing to correct. During this time, a business may suffer further problems or setbacks. Therefore, one of the main aspects FDA investigators look at during inspections in compliance with SOPs is where inspectors find violations. To avoid receiving Form 483 or warning letters, pharmaceutical companies must have detailed SOPs to ensure that employees are well-trained and consistently follow written procedures.
By all means, to achieve this outcome, an SOP document must be well-written and updated when needed. This may be quite a lengthy process. However, it saves pharmaceutical companies time and money in the long run. In addition, technical writers understand how to craft easy-to-follow yet thorough written procedures. This ensures that employees are not confused about their roles, leading to fewer mistakes.
Types of Pharmaceutical SOPs
Numerous kinds of pharmaceutical SOPs exist under FDA policy, each of which has its purpose. A pharmaceutical company must know the kinds of SOPs and what they are used for to comply with the FDA’s regulations. The most common kinds of pharmaceutical SOPs include:
Production and Quality Control
This type of SOP describes the methods of ensuring the quality, strength, and usefulness of a company’s products. These SOPs are mostly intended to be read by those workers who make the products. Production and quality control SOPs should have detailed instructions about how to do the work required to make the product. Unclear or confusing SOPs on this topic risk the distribution of poor-quality or faulty products, which can be very dangerous.
Distribution
Distribution SOPs cover the processes related to distributing and marketing a pharmaceutical business’s products. This includes coordinating the delivery of the business’s products to pharmacies, informing the public about the product and its effects, etc.
Safety and Sanitation
In the pharmaceutical industry, safety and sanitation SOPs outline the procedures for the maintenance of important resources. This includes processes such as cleaning facilities and equipment, making sure that they are safe for use, and lowering the risk of any accidents. Like with production and quality control SOPs, the instructions and procedures should be detailed to prevent confusion and accidents.
What is Required in a Pharmaceutical SOP
To ensure that a pharmaceutical SOP is sufficiently informative to avoid a form 483 or a warning letter, said SOP should have certain information, qualities, and details. First, it should clearly state what the procedure or task involves, so that workers know exactly what they need to do. This part of the document will also explain the purpose of the procedure. It should be both detailed and easy to understand when explaining how to perform the task, so workers can easily follow along. Furthermore, the SOP should make clear what resources or training is needed to accomplish the task. In addition, pharmaceutical companies should make their SOPs traceable to make sure they comply with FDA policies and rules.
Conclusion
The pharmaceutics industry involves several complicated processes, rules, and concepts that any pharmaceutical company needs to know. SOPs help significantly with this by organizing the information and making it consistently accessible. Technical writers, in turn, write the SOPs and make them as understandable and effective as possible. In essence, SOPs play a vital role in the pharmaceutics industry, while technical writers are just as necessary for SOPs to play that role.
How EDC’s Tech Writers Can Help Pharmaceutical Companies
As we have seen with the FDA-mandated destruction of millions of contaminated doses of the Johnson & Johnson COVID-19 vaccines and the closure of a Baltimore factory, noncompliance with government regulations can incur serious consequences. Therefore, to create a company setting with well-trained, confident employees, SOPs provide a steady framework for quality and safety and, through them, success.
EDC’s technical writers are experienced in navigating the exhaustive and complex regulations imposed by government agencies. They know how to write the complex language found in regulatory laws so they are easier to understand in a company setting, removing confusion. It is vital to the daily operations of a pharmaceutical company that every employee can execute their task in compliance with FDA regulations to produce safe and dependable products. Our tech writers are skilled in creating standard operating procedures and understand the importance of clear and comprehensive documentation in the pharmaceutical industry.
Whether you need a single technical writer for a brief project or a team of consultants to produce a complete line of documentation, the quality of our work is guaranteed for you. Our clients work closely with an Engagement Manager from one of our 30 local offices for the entire length of your project at no additional cost. Contact us at (800) 221-0093 or sales@edc.us to get started.
Written by Diana Guerra