Documentation has long been an important aspect of quality assurance roles across the pharmaceutical industry. While good documentation practices can be especially helpful during audits, inspections, and investigations, their utility doesn’t stop there. Documentation is a mandatory aspect of production at all levels to ensure that the products and processes of the facility remain up to standards.
With quality assurance training from the Academy of Applied Pharmaceutical Sciences, you will have the opportunity to work in a state-of-the-art laboratory that simulates working in a GMP environment. By practicing what you’ll be doing in your career down the line, you can establish strong foundational skills to maintain compliance. Continue reading to learn about documentation best practices to help you in your career.
Good Recordkeeping Habits for Reliability and Accuracy
Documentation covers the events that have occurred, when the task was completed, who was involved, and what happened next. When it comes to good documentation practices, there are a few things you should get into the habit of doing to protect your work. These include:
- Recording while doing
- Making sure your entries are legible
- Only using your signature when necessary
- Ensuring notes are as precise as possible
Strong recordkeeping skills will help your team establish consistent practices that reduce the risk of data entry errors, misinterpretations, and miscommunications. This will all come together to ensure great product quality.
Forming strong documenting habits during pharma courses will help you in your career.
Apply the Checklist Method After Pharma Courses
Creating your own set of checklists will help you remember each component of a document. You will have access to your facility’s formal standard operating procedures (SOPs) after your pharmaceutical certification program. But laying out the task at hand in your own work style will help you make sure you don’t miss a step.
Creating acronyms for memory, keeping a checklist on your desk, and referring back to your SOPs will help you master the process of documentation. Internal audits are required a few times per year, but it’s good to perform these more frequently.
Find a system that helps you stay compliant with all documentation requirements.
Going over the previous work from yourself and your colleagues will help you spot any errors or non-compliance before it becomes a larger issue. Here are a few things to remember when it comes to ensuring regulatory compliance:
- Review facility policies to ensure they are up to date and adjust as needed
- Evaluate the results of any internal audits–were there any errors?
- Consider customer feedback and any complaints received
- Create guidelines to stop problems from reoccurring
- Make sure the product at hand continues to meet customer needs
Don’t Alter or Erase Data from Records
A potential issue in pharmaceutical quality assurance is data that gets altered or erased after recording. Any amendments made to formal documentation need to be properly recorded with a time, data, and signature approving the change. You should also include a note as to why the record was altered to prove that it was a mistake that needed to be corrected. Your facility will have a procedure to follow when this situation occurs.
As a quality assurance professional, you’ll need to take documentation seriously.
Erasing and altering data is something that should not be taken lightly, as it can have rippling effects on data security and data integrity. As a quality assurance professional, you’ll want to pay close attention to any issues that may arise and be sure to follow your facility’s procedures for correction.
Are you interested in taking pharma courses to enter the world of quality assurance?
Contact AAPS for more information!