The Importance of Technical Writing for Pharmaceutical Employees
- Batch Record Forms
- Bills of Materials (BOMs)
- Specifications
- Policies
- Protocols
- Standard Operating Procedures (SOPs)
- Work Instructions (WIs)
- Test Methods
- Checklists
- Forms/Log sheets
- Training Assessments
- Electronic and hardcopy Quality records (e.g. non-conformance, corrective and preventative actions, internal inspection, change control, training records etc.)
- Certificate of Analyses (CoA) or Certificate of Compliance (CoC)
- Technical transfer reports
- Validation documentation
Technical writing skills are essential in any industry, but they are especially important in the pharmaceutical industry. Technical documents are critical to managing and directing regulated operations and to meet regulatory requirements.
The stakes are high in terms of the writing's ability to enable 100% accurate understanding of the content and where applicable, performance of the task or procedure documented. That could mean the difference between life or death, safety or injury, loss or recovery, contamination or purity, success or failure.
For example, if a batch record step is unclear or contains an error, it can lead to a variety of negative outcomes. If an error is found, the product may become unusable and clients may be lost. Employees may be hurt, and lawsuits may be filed. Worse yet, the error could go unnoticed and end up affecting a patient, causing harm or death.
The Requirements
Good Manufacturing Practice (GMPs) in the pharmaceutical sector demand that instruction materials such as Standard Operating Procedures (SOPs) be error-free and well-written. Creating SOPs is a regulatory requirement. The FDA, ISO, and ICH guidelines frequently mention requirements for SOPs. Many parts of Title 21 in the Code of Federal Regulations (CFR), describe the requirements. Manufacturing documentation, problem reporting, laboratory test methodologies, batch production records, and so on all need to be crystal clear in their instructions.
The following basic Good Documentation Practices (GDP) requirements must be met by all documentation and records utilized throughout the manufacturing process, as well as supporting procedures such as quality control and assurance:
The Challenges
Employees with both content understanding of their profession and the skills required to produce a technical document are tough to come by. It's considerably more difficult to locate an employee who has taken a technical writing course, and because many colleges don't offer technical writing as a specialty in the English department, it's even more difficult to find someone with a technical writing degree.
Advanced technology may have pushed efficient communication to the side, resulting in clear writing becoming a lost skill that is now due for resurgence. In the Information Age, there is an abundance of technical data, but very little of it is expressed in plain English. Compliance auditors who need to swiftly analyze whether an unfamiliar organization meets criteria may be confused by unclear communication.
The Solution
So, if employees lack the ability to write clear, error-free instructions, how can companies compensate for the shortfall?
By sending employees to technical writing workshops that detail the general characteristics and strategies of using writing techniques.
The Advantages
Everyone in the company who creates the documentation must be able to communicate detailed manufacturing processes to achieve the end goal quickly and efficiently. As patient lives are involved, the steps must be written carefully. Gathering the information to be included in the technical document requires collaboration between the writer and the various subject matter experts that possess the knowledge to be harvested. A technical writing course can help address the most effective techniques for extracting information from subject matter experts as well as those techniques that work best when observing procedures and activities to be documented.
Effective Technical writing courses help any organization achieve excellent results by training employees to produce high-quality content and acquire the skills to customize reader-focused technical documents. Customers and clients will appreciate the company's documents and communications having a consistent professional appearance, and they will feel educated and confident in the information offered to them. As a result, more customers and clients can be attracted, the value of stakeholders can be increased, and staff relations can be improved across the board.
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