The pharmaceutical industry has an extremely high standard when it comes to ensuring the quality and safety of pharmaceutical products. This is why the Good Automated Manufacturing Practice (GAMP) was created. In simple terms, GAMP validation is a set of guidelines used in the pharmaceutical industry to ensure that automated systems and all software used in the production and supply chain of pharmaceutical products are reliable, consistent and compliant with regulatory requirements.
Why does the pharmaceutical industry need to be GAMP validated, you ask?
Let’s say, if something goes wrong and a product has unexpected side effects. The ability to trace the defected product back through the supply chain until the start of the purchase order can be easily accessed to pin-point exactly at which stage the product became defective. Patient safety is imperative in this industry, hence the need for stringent guidelines with the quality control process including computerised systems, documentation and software that help manufacture and distribute pharmaceutical products across the supply chain.
By following the steps outlined in the GAMP framework, pharmaceutical companies can navigate the complex landscape of regulatory requirements while ensuring the highest levels of product quality and patient safety. Apart from patient safety, there are certain areas that GAMP focuses heavily upon, a few of these are:
- Data Integrity – The ability to maintain accurate records of manufacturing processes and quality control is necessary. Through GAMP validation, the automated systems accurately capture and store data, preventing data manipulation or corruption.
- Risk Mitigation – Even automated systems can malfunction from time to time, GAMP can helps identify and mitigate these risks through systematic validation processes, where every process in the system is tried and tested, to ensure that malfunctioning errors can be avoided before they occur.
- Regulatory Compliance – A heavily regulated pharmaceutical industry needs to ensure the safety and efficacy of their products. Through a structured approach to validating automated systems and software, GAMP helps companies meet regulatory requirements such as the FDA CFR 21 – Part 11 and the EU Annex 11.
As each regulatory organisation periodically updates their regulations and guidelines, it can be challenging to align GAMP practices accordingly.
Our Validation Journey
OneSC was built to focus on unifying batch documentation and progress reporting specifically to provide transparency and visibility into monitoring batches and shipments through a digital network. This in turn, would minimise production delays and decrease the lack of coordination between various supply chain departments. However, quality assurance specialists and quality control teams within pharmaceutical supply chains were hesitant to use our platform as we were not GAMP validated at the time.
And so, the process began. First, we addressed each point of concern given to us by quality specialists; redesigning OneSC to account for and represent all concerns. The real challenge was going through the steps of GAMP validation. OneSC was our first product, we had no prior experience and had started from scratch, learning as we went ahead. The sheer size of the GAMP validation process was immense at each stage with lengthy documentation for each and every function of the platform. Everything has to be accounted for; from data integrity, product quality, patient safety, quality assurance and more.
Within the GAMP process, there are other validation tests to be conducted such as the Good Distribution Practice (GDP) that has their own guidelines regarding the transportation and distribution of products to ensure that OneSC does not negatively impact supply for any other supply chain partners. As we generated validation documents for each stage, our platform started to feel the weight of the process. Making changes to a pharmaceutical supply chain software for compliance is not easy, however, we did have assistance from other pharmaceutical and supply chain specialists to ensure we were on track.
The main challenge was meeting regulatory requirements such as the FDA CFR 21 – Part 11 which deals with electronic documentation and electronic signatures, and the EU Annex 11 that outlines requirements for using computerised systems operating within the European Union.
After months of dedicated effort and continuous improvement, we successfully attained GAMP validation for OneSC. Pharmaceutical supply chains can now use our platform with ease knowing that we adhere to the highest of industry standards. Thank you for your support.