A lab technician examining a set of test tube experiments

In the Pharmaceutical Industry, Standard Operating Procedures (SOPs) provide the foundation for efficiency and success for a pharmaceutical company. SOPs allow a pharmaceutical company to follow the regulations. The regulations set forth by the FDA (Federal Drug Administration). Further more, laws are in place to uphold quality assurance and control. However, the documentation of such procedures allows for the standardization of vital processes. Including sanitation, cleaning, and maintenance of equipment, production and process control, sampling and testing, etc. Any inadequate documentation of these procedures can be extremely costly for a pharmaceutical company. Lack of well-documented SOPs can result in loss of product. This 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. Besides, 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. The technical writer helps assure 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 assure employees to complete their jobs successfully. In addition, the pharmaceutical industry, these written procedures help employees achieve a task required by the FDA. These written procedures  also, assist in quality assurance, consistency, training new employees, and help reduce mistakes in the manufacturing process, among a myriad of other benefits. 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. Also, 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 complex for employees if they are vague or too complex to follow. Straightforward SOPs permit employees to carry out their tasks confidently. However, this allows less chance of error, saving the company money and assuring consistent product quality.   

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 coPlus, ntrol procedures. This process confirms that their products have the identity, strength, quality, and purity stated by the company. These written procedures are for the use of employees to complete procedures including but not limited to the following:

  • Responsibilities and procedures of the quality control unit
  • Including, 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 process
  • Also, 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 daunting 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) defined by Form 483 and warning letters can be costly. This could cost the company hundreds of thousands of dollars to millions.

Further, these violations may take months of fixing and testing to correct. Therefore, one of the significant aspects FDA investigators look at during inspections in compliance with SOPs is where inspectors find violations. To avoid receiving a 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, the 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. So that employees are not confused about their particular roles, leading to fewer mistakes can only be found by an FDA inspection. 

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 establish a company setting with well-trained, confident employees, SOPs provide a steady framework for consistent quality and safety and, as a result, success.  

EDC’s technical writers are experienced in navigating the exhaustive and complex regulations imposed by government agencies. They know how to translate the complex language established in regulatory laws so they are easier to understand in a company setting, eliminating unnecessary 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 knowledgeable in creating standard operating procedures and understand the importance of clear and comprehensive documentation in the pharmaceutical industry.

Essential Data’s Engagement Manager will lead the project from start to finish, whether you need a team of consultants to produce a complete line of documentation or a single technical writer for a brief project. Essential Data Corporation guarantees the quality of our work. Contact us today to get started. (800) 221-0093 or sales@edc.us

Written by Diana Guerra