Key areas of focus
Whenever we talk about a greenfield pharma facility, GMP and its compliance have always been 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. Today, as regulatory expectations evolve and technologies advance, staying aligned with modern interpretations of cGMP guidelines is more critical than ever. This article throws light on how small to mid-sized manufacturing facilities can achieve 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 protects the end-user — the patient — it also ensures that the risk of contaminating the product is reduced or detected and controlled quickly. This, in turn:
- Maximizing operational efficiency
- Eliminating wastes
- Improving organization’s bottom line
With the latest CGMP guidelines emphasizing risk-based approaches and data integrity, staying compliant also means staying competitive.
What equipment does the facility rely on when coordinating aseptic/sterile processing activities?
Many alternative automated methods can replace traditional approaches that 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.
Today, smart sensors, AI-enabled monitoring systems, and integration with building automation systems (BAS) have become integral to achieving real-time GMP compliance. These are especially relevant in pharmaceutical engineering where efficiency, safety, and traceability are crucial.
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 particularly 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, creating higher throughput in the lab’s general operation. It also reduces staff stress and anxiety by minimizing the chances of error, the need for retests, and the potential burden of performing investigations for root cause. These factors alone can greatly improve the overall value, utility, and employee satisfaction in an organization.
With shift toward Industry 4.0, integration of digital twins and modular automation is becoming the gold standard for aseptic processing. EPC companies with domain expertise are leading the way in helping manufacturers embed these innovations effectively.
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 rely on the comfort of traditional methods. However, they fail to realize that as a startup, they have the perfect opportunity to innovate and use modern methods right from the start, rather than try to overcome inertia later. Investing time to gain the knowledge and experience of using the best available methods early on will set up startups for success in the long term.
Using rapid, alternative methods not only ensures GMP compliance from day one, but also 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:
- No cleaning validation
- Easy product changeover (ideal for multi-product facilities)
- No risk of cross-contamination
Additionally, digitized validation protocols, paperless documentation systems, and centralized compliance dashboards are reshaping how startups handle CGMP requirements.
Working with a reliable and trusted partner like Pharma Access — with a deep understanding of pharmaceutical engineering and experience in engineering consulting — ensures that revalidated components are easily incorporated into processes. We also provide effective support and verification of your supply chain.
At Pharma Access, we bring deep expertise in GMP compliance documentation, supporting both greenfield and brownfield pharmaceutical projects. As an experienced EPC partner, we work closely with you to design and build facilities that are compliant, efficient, and ready for future growth.
Reach out to us at sales@pharmaaccess.net or visit www.pharmaaccess.net to learn how we can support your next project.
