You should know that in general terms, pharmaceutical products manufacturing has to comply with certain strict standards in order to ensure quality and purity of the finished products.
In addition, every pharmaceutical production site must have internal procedures that aim to comply with these FDA regulations. Note that FDA or the Food and Drug Administration is an American agency of food and drug products.
It is a government department responsible for pharmacovigilance. Its mission is to ensure the study, control and regulation of drugs before they are marketed. In addition, FDA’s objective is to ensure the quality of products marketed in its territory by guaranteeing compliance with the rules it imposes on companies. In this context, it carries out inspections within both American companies and foreign ones that export to the USA.
However, several manufacturers find it difficult to measure and improve their operational efficiency to optimize their compliance. In this article, we will offer you essential points that it is important to focus on in order to comply with FDA standards.
Introduction to pharmaceutical production process
In pharmaceutical industry, it is essential to respect procedures and steps of each operation within the pharmaceutical manufacturing. In fact, you should know that each project is rigorously regulated and processes have to take place according to a precise order.
Generally, pharmaceutical companies collect and analyze data throughout the whole production processes in order to ensure that the finished products meet quality and security standards.
This information must be complete, accurate and permanently protected against accidental or malicious modification.
It is important to highlight that data play an essential role in every pharmaceutical production operation. Data loss or dissemination of erroneous data can expose the company to fines, delays in product approval or even criminal prosecution.
Therefore, manufacturing data protection is vital at each stage of production and access, from initial registration to validation and archiving.
Real time visibility
Note that paper work instructions do not enable you to gather important information such as photos, videos or even comments. In addition, by working with paper work instructions, you cannot share the completion status of operations in real time. This prevents optimal visibility into the progress of operations. As a result, using digital work instructions, the operator in charge of operations sends live information on a “no- code” platform.
In order to ensure your company’s compliance with FDA regulations, it is important that your pharmaceutical industry guarantees data visibility in real time. To do this, it is recommended that you use a digital tool that will record and share live data pertaining to pharmaceutical processes.
A connected workshop can increase productivity and allows a better decision-making.
Communication between teams in real time
To comply with FDA standards, a pharmaceutical industry must also rely on real time communication between teams. In fact, this helps to ensure easy information transmission in the workshop. The most important thing is to establish the right information exchange method without having an erroneous message.
It is highly recommended that you set up a real time notification system. This will help to notify the right people or the right team of an event pertaining to the ongoing operation or change of status. This way, visibility is increased and waste of time reduced.
Therefore, we can say that a good communication allows data transmission in an accurate and clear manner. This will help to improve work within the industry and ensure a significant amount of time.
Data collection and process improvement
You should know that paper data management is no longer the best way to save information. In fact, over time, writing can be sometimes illegible.
In addition, using paper work instructions has shown that it is a counterproductive method that might lead to extra workload. In fact, these manual tasks become long and redundant on a daily basis which can quickly turn into a real obstacle to efficient data collection. Also, paper work instructions will restrain optimal collection and use of company data. Besides, it is important to highlight that hand-recording and manual data entry are prone to human error. In fact, even though the level of alertness is at its highest, distractions still occur and this is of course at the expense of time.
Using a digital solution guarantees that data collection and entry are done only once. Also, this helps to ensure that the collected information is both accurate and reliable.
On the other hand, data monitoring helps to analyze where operations can be improved. In this respect, in addition to gathering a company’s data and integrating it directly into its Business Intelligence tools, the advantage of a digitalization tool is to make an optimal analysis.
Thanks to Picomto, you can digitalize your work instructions. In fact, this tool helps you to digitalize all your operations and thus comply with FDA standards while optimizing your production processes. In addition to offering you the possibility to create and easily manage work instructions, this software will help you gather and share the data you need to monitor each aspect of production.
Picomto is able to record data pertaining to pharmaceutical processes in digital form so that data would be available in real time.