Pharma & packaged water compliance

Across both pharmaceutical production and the packaged-water market, regulators have moved from guidance to scrutiny. The World Health Organization’s revised guideline on water for pharmaceutical use makes lifecycle control explicit - design through qualification and into ongoing operation - and recognises non-distillation routes to water for injection, provided the system is designed, qualified and monitored accordingly. That shift, coupled with tougher contamination-control expectations in the EU/UK’s GMP Annex 1, raises the bar for how plants specify, validate and run water systems day-to-day. In practical terms, “documented control” has replaced “installed equipment” as the proof point.

Packaged-water oversight is tightening in parallel. Nigeria’s regulator, NAFDAC, has reiterated that no packaged water may be manufactured, advertised, sold or distributed without registration, and it has stepped up enforcement against unregistered and unsanitary sachet operations, including factory closures in March 2025. Ghana’s FDA has issued public warnings against improperly labelled or unsafe products while academic reviews continue to test sachet quality and flag inspection gaps. The message to operators is unambiguous: registration, labelling, plant hygiene and traceability are minimum conditions to trade, not nice-to-haves.

Two currents are converging. On the pharma side, the 2021 WHO update consolidated global expectations around design qualification (URS, DQ), installation/operational qualification (IQ/OQ), performance qualification (PQ) and trending control, with explicit language on membrane-based WFI that requires risk-based monitoring and robust sanitisation strategy. In sterile manufacturing broadly, the 2023 Annex 1 revision pushed the industry toward formal Contamination Control Strategies that treat water systems as part of the clean-utility ecosystem, linked to premises design, qualification, monitoring and corrective action. It is no longer sufficient to pass a one-off FAT/SAT; authorities expect a living system that proves state of control over time.

On the consumer side, regulators are reacting to scale and risk. Sachet and bottled water now serve millions of households daily; where oversight has lagged, authorities have moved to close illegal plants, enforce registration and crack down on mislabelling. Recent actions in Nigeria’s FCT and public warnings in Ghana reflect a broader regional normal: plants need documented hygiene, fit-for-purpose equipment, and product traceability that stands up under inspection. Enforcement may be uneven market-to-market, but the direction is unmistakable.

In Nigeria, NAFDAC’s playbook is clear. Operators must register products, meet facility and personnel standards, and maintain records that correlate batches to source water, treatment steps and test results. The “Guidelines for Establishment of Packaged Water Plant” spells out responsibilities, from organisational structure and sanitation to lab controls and labelling - expectations that inspectors are increasingly enforcing in the field. For pharma sites, aligning purified water and WFI loops to WHO TRS 1033 principles - sanitisation regimes based on data, alert/action levels that reflect real risk, and periodic re-qualification - is the cleanest path through pre-approval and routine inspections.

Ghana shows a similar pattern. FDA communications and peer-reviewed work point to steady improvements in sachet quality where producers are registered and audited, coupled with continued concern about inspection frequency and franchised production. The operational takeaway is simple: treat Ghana’s framework as “GDPR-grade for water” - clear notices, current licences, and evidence that your plant meets national standards and Ghana Standards Authority specifications. Doing the unglamorous paperwork is what keeps lines running when media attention spikes.

Even if you manufacture outside the EU/UK, Annex 1 shapes buyer expectations worldwide. The 2023 revision tightened expectations for contamination control across sterile operations, and many of its principles bleed into non-sterile contexts via quality risk management. Sponsors, CDMOs and auditors increasingly expect to see water systems embedded in a site-wide contamination control strategy, with trending, alarms and investigations that connect utilities to product risk. Sites exporting to - or audited by - EU/UK clients are discovering that Annex 1 is less a region-specific rule than a common language for proving control.

The pharmacopeial conversation is also moving. USP has continued to evolve <1231> Water for Pharmaceutical Purposes, clarifying design, control and testing concepts and signalling best practice around sanitisation temperatures and regimes. While USP is not law in West Africa, its influence on multinationals and their supplier qualifications means local plants benefit from aligning design choices to the latest consensus. It reduces audit friction and speeds technical approvals.

Audit-ready design is a mindset. Start by writing a user requirement specification that ties capacity, quality attributes and critical design choices to product risk. Translate that into a defensible P&ID, materials of construction and a sanitisation philosophy that your team can actually run. Then qualify honestly - DQ, IQ, OQ, PQ - with acceptance criteria that mirror WHO TRS 1033 and your own risk analysis, not wishful thinking. When inspectors arrive, what convinces them is the thread: requirements to design, design to verification, verification to ongoing trend control and CAPA. That is what turns “show us your data” from a crisis into a routine.

For packaged water, the same logic applies at different scale. Build plants that make hygienic practice the default: segregated flows, washable surfaces, validated disinfection cycles, and finished-product testing tied to lot release. Keep registration current, labels consistent with approvals, and training records live. When enforcement intensifies - as it has this year in Nigeria’s FCT - the operators who keep trading are those whose evidence is one binder or one click away.

Our position is straightforward: compliance is not a tax on growth; it is how you keep growth bankable. We design water systems and packaged-water plants to “prove control by default,” so the actions that keep you compliant are the same actions that keep you efficient. For pharma, we deliver end-to-end: URS drafting, code-aligned design, commissioning and qualification packs (DQ/IQ/OQ/PQ) built on WHO TRS 1033 and aligned with Annex 1 contamination-control thinking. We embed monitoring, alert/action levels and trend reviews into SOPs so deviations are caught early and closed cleanly. For packaged-water producers, we align your facility to NAFDAC or FDA Ghana expectations, prepare registration dossiers, and implement lab and sanitation regimes that stand up in inspections.

We also handle the quiet but crucial work: supplier qualification for filtration and membrane skids, calibration and maintenance plans tied to release decisions, and training that turns procedures into habit. When enforcement tightens - as it is doing across West Africa - our clients ship without drama because their documentation is current, their investigations are real, and their plants are designed to make the right thing the easy thing. That is where technical credibility and regulatory peace of mind meet.