Documentation is a large component of quality assurance roles. It is used to record data, abide by company policies, and guide the safe development of pharmaceutical products with the ability to track their production throughout the entire process. Good Documentation Practices, also called GDP, help protect both the company and the public with a thorough tracking of every step in the quality assurance process.
At the NeuAge Institute, students earning their certification in Quality Assurance cover a number of essential topics for a rewarding career in the field. These include Pharmaceutical Manufacturing Methods, Introduction to Quality Documents and Technical Writing, Good Documentation – Data Integrity, Advanced Pharmaceutical Auditing, and more. This wide range of courses allows for a comprehensive understanding of the role of the quality assurance professional and sets students up for success in their future careers. Continue reading to get a head start on tips for GDP for the pharmaceutical industry.
1. Make Entries Clear and Legible on All Records
It is important during a pharmaceutical quality assurance program to make note of the specifics when it comes to Good Documentation Practices. When starting out, make sure that all entries are clear and legible on any records that are being stored for the long term. Clear documentation is void of errors, clearly legible, and unobscured. The accuracy of each document is a top priority, adding to its integrity.
During quality assurance certification at the NAI, students examine the FDA’s requirement for data integrity. Data integrity is a key component in making informed decisions within any regulated organization, as reliable data promotes good decisions. Clear documentation is one component of data integrity that ensures that records are easy to extract important information from when the time arises.
2. Record Entries Contemporaneously During Quality Assurance Training
The importance of recording entries and key documentation notes contemporaneously cannot be stressed enough. In the ongoing development of pharmaceutical processes, production, and innovation, all steps of each endeavor need to be accurately recorded for review. The pharmaceutical industry is always changing, and this means that there are constant updates to FDA regulations, on-site procedures, and even data collection and recording. When entries are documented contemporaneously, it leaves less room for error and provides an accurate record of the events that occurred. Unmanaged and inaccurate data will have consequences on a company’s quality output, state of compliance, the risk to patient safety, and, ultimately, the company’s reputation. Contemporaneous documentation can help students avoid these risks during quality assurance training.
3. Ensure Each Document is Complete and Accurate
Incomplete, unfinished, and forgotten documents are inappropriate in a quality assurance setting. A tip for students entering this field is to slow down, analyze, and review each document to ensure that all necessary information is present. This way, if a colleague needs to access the document for information, they won’t need to come to find you in order to get more information or decipher what is on the record.
Another important aspect of GDP is that all records are attributable. This means that it is clear who created or recorded the document, which protects against claims of falsification or forgery. When the document is attributable, then it is clear who is responsible for the information, and it increases the likelihood that it is accurate. Handwritten signatures are common practice for this, and most facilities keep a handbook of employee signatures so that they are easily traceable and identifiable.
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