In the Pharmaceutical Industry, Standard Operating Procedures (SOPs) provide the foundation for which efficiency and success can be achieved for a pharmaceutical company. SOPs allow a pharmaceutical company to follow the regulations set forth by such government organizations as the FDA and are used to uphold quality assurance and quality control. 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, 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 the creation of precise SOPs. Tech writers have the necessary skill set that allows them to produce documentation that outlines all aspects needed in standard operating procedures as required by the FDA. Their technical knowledge and ability to translate difficult material into clear-cut information help assure the development of written procedures that can be easily understood and followed to a tee.
The Purpose of SOPs
At its core, SOPs are guides that meticulously detail all the steps that go into a procedure that an employee, or employees, must follow to successfully complete their particular job. In the pharmaceutical industry, these written procedures not only help employees complete a task, but are required by the FDA. These written procedures 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, governmentally imposed penalties, and can deeply affect public confidence in a company’s products. One of the most common regulatory compliance issues that plague the pharmaceutical industry is the lack of proper written documentation.
A solution to this issue lies in the development of clear and concise documentation of SOPs. Highly technical procedures may be difficult for employees to follow if they are vague or too complex to follow. Straightforward SOPs permit employees to carry out their tasks with confidence and with less chance of error, saving the company money and assuring consistent quality in their products.
SOPs and FDA Regulations
Under the FDA’s Code of Federal Regulations Title 21, the FDA stipulates that pharmaceutical companies must have written procedures for production and process control to confirm that their products have the identity, strength, quality, and purity as stated by the company. These written procedures are meant for use by employees in completing 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 process
- 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 conform with all established standards, specifications, and characteristics
- Testing and release for distribution
Each of these procedures not only needs to be well documented but must also be updated periodically. The extensive documentation required for compliance with FDA regulations can be a daunting task but is absolutely necessary for all pharmaceutical companies. Technical writers have the know-how when it comes to developing and updating SOPs so they comply with FDA regulations.
The Consequences of Inadequate Documentation
The FDA conducts inspections of pharmaceutical manufacturing companies to assure that they adhere to good manufacturing practices. If FDA inspectors find any potential regulatory violations during the inspection they may issue a Form 483, which can be escalated to an FDA warning letter for serious violations. Rectifying the violation(s) defined by Form 483 and warning letters can be costly, ranging from hundreds of thousands of dollars to millions. Additionally, these violations may take months of fixing and testing to correct. One of the significant aspects FDA investigators look at during inspections is compliance with SOPs and this is typically where inspectors find fault. To avoid receiving a Form 483 or warning letters, pharmaceutical companies must have clearly detailed SOPs to ensure that employees are well trained and consistently follow written procedures.
Of course, this is primarily achieved by well-written SOPs that are consistently updated when needed. This may be quite a lengthy process but in the long run, it saves pharmaceutical companies time and money. 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 that may be caught during FDA inspections.
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. In order 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 difficult 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 per 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.
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’s Engagement Manager will lead the project from start to finish. At Essential Data Corporation, the quality of our work is guaranteed. Contact us today to get started. (800) 221-0093 or firstname.lastname@example.org
Written by Diana Guerra