A pharmaceutical facility does not prove its success when the project is commissioned, qualified and handed over. The real test begins when the project teams leave and the facility has to perform consistently, day after day. From equipment reliability and utility performance to maintenance, GMP compliance, digitalisation and sustainability, long term performance depends on how well different parts of the operation work together.
In this conversation, Narender Pal Singh, Vice President & Site Head, Operations & Projects at Panacea Biotec Ltd., draws on more than 26 years of experience across pharma manufacturing, engineering and operations to explore what separates a facility that simply starts production from one that continues to perform reliably over the years.
1. A facility may be successfully commissioned and qualified, but that does not always translate into stable production. What are the first signs that tell you a facility is genuinely settling into reliable operations?
Commissioning and qualification confirm that a facility has been designed, installed and tested as intended. Stable operations begin when those systems perform consistently under real production conditions.
The signs are practical: deviations reduce, utilities remain stable, operators become comfortable with the equipment, maintenance becomes predictable, and dependence on project teams or vendors falls. Production planning also improves as the site better understands its actual capacity and operating limits.
A mature facility also sees fewer temporary fixes and repeated interventions. Problems are identified earlier, trends become visible, and teams move from firefighting to prevention. Most importantly, the facility delivers predictable output without placing unusual stress on people, utilities or equipment.
A facility is truly stable when it stops surprising the people who operate it every day.
2. Once production starts, some project decisions prove to be very good while others become recurring headaches. Which decisions around facility design, utilities, equipment or automation tend to have the biggest impact on site performance later?
The decisions that matter most later are often the ones that appear ordinary during the project stage.
Layout and access are good examples. If equipment is difficult to maintain, filters cannot be changed easily, utilities are tightly packed, or maintenance access was not considered properly, the site pays for that decision for years.
Utility design is equally important. Redundancy, turndown capability, segregation, clean utility loops, drainage, HVAC zoning and adequate instrumentation have a major impact on reliability. A system designed only for peak load, without considering partial load or future changes, often becomes inefficient or unstable during actual operations.
Equipment standardisation also helps. If every skid, PLC, valve or instrument comes from a different platform, maintenance becomes complicated and spares inventory increases.
Automation decisions are another area where short-term savings can create long-term problems. Systems should be simple enough for operators to use, but robust enough to provide traceability, alarms, trends and data integrity.
Good project design is not only about making the facility run on day one. It is about making it easy to operate, maintain and improve for the next ten years.
3. Reliability problems are often blamed on individual equipment. In your experience, how often does the real issue sit somewhere between equipment, utilities, maintenance and operating practices? How do you get to the root cause?
Very often, the equipment is only where the problem becomes visible; the actual cause may sit somewhere else.
A repeated trip on a machine may be linked to unstable compressed air, poor chilled-water control, fluctuating power quality, maintenance practices, sensor calibration, process loading or even operator sequence.
That is why root-cause analysis should not start with the assumption that a particular machine has failed. It should begin with the complete operating system around it.
A practical approach is to look at four layers together: equipment condition, utility stability, maintenance history and operating practice. Trend data is very useful here. If we compare alarms, utility parameters, breakdown history and batch events over time, patterns often become visible.
Cross-functional review is also essential. Engineering may see a mechanical issue, operations may see a process issue, and quality may see a recurring deviation. The real root cause often appears only when all three views are put together.
Reliability problems rarely respect departmental boundaries, so root-cause analysis should not either.
4. A facility that passes its initial GMP qualification still has to remain compliant year after year. What tends to become difficult to maintain as a facility ages, particularly when production pressure and frequent changes come into the picture?
The biggest challenge is maintaining discipline over time.
When a facility is new, systems are clean, drawings are current, qualification status is fresh and everyone is conscious of procedures. As years pass, modifications are made, equipment is replaced, production priorities change and temporary arrangements can slowly become permanent.
The areas that become vulnerable are change control, documentation accuracy, preventive maintenance, calibration, alarm management, cleanroom integrity, utility performance, material and personnel flows and configuration control of automated systems.
Production pressure can also create a tendency to postpone maintenance or accept small deviations as normal. That is where risk starts accumulating.
Periodic review is therefore critical. Facilities need structured re-assessment of critical systems, trends, recurring deviations, aging equipment, obsolete controls and capacity margins. The question should not only be, “Is it still qualified?” but also, “Is it still operating within the assumptions on which it was originally qualified?”
GMP compliance is not preserved by the original qualification package; it is preserved by disciplined change management throughout the facility life cycle.
5. Engineering teams and operations teams can look at the same facility very differently. What have you found helps bring those two perspectives together when making decisions on reliability, maintenance or capacity?
Both perspectives are valid, but they come from different priorities.
Operations looks at output, cycle time, manpower, schedule and batch continuity. Engineering looks at equipment health, maintenance windows, system loading and long-term reliability.
The best decisions come when both teams work from the same data.
For example, instead of debating whether maintenance should be postponed, the discussion should look at equipment criticality, failure history, condition-monitoring data, production impact and available redundancy.
Joint daily reviews, common KPIs and shared ownership of critical assets help significantly. Maintenance should not be something engineering “does to” operations. It should be part of the operating plan.
Similarly, capacity discussions should include both process capability and utility capability. Increasing production on paper is easy; understanding whether HVAC, water, steam, compressed air, manpower and maintenance systems can support that increase is more important.
Operations protects today’s output; engineering protects tomorrow’s output. Reliable facilities need both perspectives at the same table.
6. Digitalisation is now reaching areas that were traditionally managed through manual systems and paper records. Having started the eQMS journey at Panacea, what changes when digital systems become part of the way a site actually manages compliance and operations?
The biggest change is visibility.
In a paper-based system, information exists, but it is often fragmented across files, departments and timelines. Digital systems bring deviations, CAPAs, change controls, training, document status, audit actions and quality events into one connected environment.
This improves traceability and accountability, but the bigger benefit is the ability to see trends early.
For example, a recurring deviation may not look significant when each case is reviewed independently. In a digital system, the pattern becomes visible across equipment, department, product or time period.
Digitalisation also shortens review cycles and makes follow-up more disciplined because responsibilities and timelines are transparent.
However, technology alone does not improve quality. Poor processes only become poor digital processes if the underlying workflow is not redesigned.
The real value comes when digital systems are used not only to record compliance activity, but to support management decisions.
The shift is from recording what happened to understanding what is happening.
7. Energy and resource efficiency are increasingly being discussed alongside GMP, reliability and cost. Where have you seen sustainability initiatives make practical sense at a pharma site, rather than becoming a separate programme running alongside manufacturing?
Sustainability works best when it is integrated into normal operating decisions rather than treated as a separate programme.
Pharma facilities consume significant energy through HVAC, chilled water, boilers, compressed air, clean utilities and continuous environmental control. Many sustainability opportunities therefore also improve reliability and operating cost.
Examples include optimising HVAC air changes based on validated requirements, variable-frequency drives, heat recovery, improved insulation, efficient chilled-water systems, leak reduction in compressed air, condensate recovery, water reuse where technically and regulatory acceptable, and better monitoring of utility consumption.
Real-time monitoring can also make a major difference. When energy, pressure, temperature, humidity or utility performance is continuously trended, systems can be adjusted based on actual demand rather than operating permanently at conservative maximum settings.
The key principle is that product quality and GMP requirements remain non-negotiable. Sustainability initiatives should improve efficiency without reducing process control.
The best sustainability projects are those where quality, reliability and resource efficiency improve together.
A pharmaceutical facility should not be judged only by how well it was commissioned. Its real test begins after the project team leaves.
The facilities that perform well over time are usually not the ones with the most sophisticated equipment. They are the ones where design, operations, engineering, maintenance, quality and digital systems remain connected throughout the facility life cycle.
A successful pharma project creates a qualified facility. A successful operating model keeps that facility reliable, compliant and competitive year after year.
About the guest
Narender Pal Singh is the Vice President & Site Head – Operations & Projects at Panacea Biotec Ltd., with over 26 years of experience in pharma manufacturing, engineering and operations leadership. His career spans greenfield and brownfield facilities across pharma, oncology, vaccines and biotech, with responsibility for site performance, P&L, CAPEX, OPEX, compliance and operational strategy.
His core interests include manufacturing and process optimization, operational excellence, HVAC/IAQ, cleanrooms, utilities, contamination control, reliability, sustainability and quality systems. He is an active industry speaker, trainer and university committee member, with contributions across ISHRAE, DCVMN, ETPharma and Express Pharma platforms, and executive learning from TIET, BITS Pilani and ISB.
Disclaimer: The views and opinions expressed in this editorial are those of the interviewee and are based on his professional experience across pharmaceutical supply chains, networked manufacturing, regulatory strategy and technology-enabled operations. They do not necessarily reflect the official views, policies, or positions of Hello Pharma, its management, or its affiliates. Hello Pharma does not endorse or take responsibility for any specific technical, commercial, or regulatory interpretations presented in this article. Readers are encouraged to independently evaluate the information shared, review applicable regulatory guidance, and rely on their own experience, expertise, and professional judgement before making decisions related to manufacturing strategy, partner selection, technology transfer, or regulatory compliance.
