Key areas of focus
Whenever we talk about a greenfield pharma facility, GMP and its compliance has always in discussion. Taking the proper steps to comply with current good manufacturing practices (cGMPs) for aseptic and sterile processing in an efficient and effective manner is necessary for pharmaceutical manufacturing facilities and labs and this article will throw some light on how some small to mid sized manufacturing facilities can achieve its compliance, by adopting simple cost-effective methods.
Why is compliance to cGMP so important?
While practicing GMPs ensures a safe, efficacious, and high-quality product that preserves the safety of the end-user: the patient, it also ensures
that the risk of contaminating the product is reduced or detected and controlled quickly, thereby
- Maximizing operational efficiency
- Eliminating wastes
- Improving organization’s bottom line
What equipment does the facility rely on when coordinating aseptic / sterile processing activities?
Many alternative automated methods can replace traditional methods that can pose a risk of non compliance with GMPs. As far as possible, equipment fittings and services should be designed and installed so that operations, maintenance and repairs can be carried out outside the clean area. Equipment that must be taken apart for maintenance should be re-sterilized after complete reassembly, wherever possible.
What are the best practices for manufacturers to improve / enhance their aseptic / sterile processing activities?
A further way of enhancing aseptic / sterile processing is to reduce risk through automation. A particular critical unit operation during biomanufacturing is the final filling of the drug product. To this end, equipment such as an automated vial filler and capping unit could be used to provide an aseptic environment and control of process steps.
Day-to-day improvements to workflows are easily achievable through implementing more automation in the microbiological quality control lab. This speeds the time to result of many assays, which creates higher throughput in the lab’s general operation. It also reduces stress and anxiety on the staff by reducing the chances of error, the need for retests, and the potential burden of performing investigations for root cause. These alone can greatly improve the overall value, utility, and employee satisfaction in an organization.
How can Pharma Access help new organizations (e.g., small start ups), specifically on how to practice and comply with GMPs?
Startup organizations often mistakenly feel they don’t have the expertise or capacity to implement rapid methods in the beginning and trust the ease and comfort of traditional methods. However, they fail to realize that as a startup, they have the perfect opportunity to innovate and use modern methods in the beginning, rather than try to overcome inertia and reliance on these methods later. Investing the time to gain the knowledge and experience of using the best available methods early will set up startups
for success for years down the road. Using rapid, alternative methods not only ensures GMP compliance right out of the gate, but ensures successful business operations by optimizing production, improving product quality, and reducing risks.
For new companies, there are a number of ways to comply with GMP regulations. The increasing use of pre-sterilized systems such as single-use assemblies offers several advantages that include: no cleaning validation; easy product changeover, particularly for multi-product facilities; and no cross contamination. Additionally, working with a reliable and trusted partner like Pharma Access with knowledge of GMP regulations means that revalidated components are easily incorporated into processes and they can also provide effective support and verification of their supply chain.
We at Pharma Access have our subject matter experts who boast hands on experience in GMP compliance documentation of greenfield and brownfield pharmaceutical projects.
Get in touch with us at sales@pharmaaccess.net or visit us at www.pharmaaccess.net to know more about the services we offer.
