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Pharmaceutical quality is not a single activity — it is a system. The objective, as defined by ICH Q10, is to establish and maintain a state of control, facilitate continuous improvement, and ensure that products meet the quality attributes appropriate for their intended use.

The PQS applies across four lifecycle stages: pharmaceutical development (QbD, CQAs, CPPs, control strategy), technology transfer (from R&D to manufacturing and between sites), commercial manufacturing (GMP operations, continuous verification) and product discontinuation.

Underpinning the PQS are two cross-cutting disciplines: quality risk management (ICH Q9), which ensures that risk decisions are rational and documented; and data integrity (ALCOA+), which ensures that all data used to make quality decisions are reliable, attributable and reconstructible.

The following sections describe each element of our quality system. They are based on the regulations and guidelines issued by FDA, EMA, ICH, WHO, USP and Ph. Eur., and reflect current pharmaceutical industry practice.

ICH Q10 — four PQS elements

Continual assessment of process capability and product quality, including trend analysis and statistical process control. Corrective and preventive action driven by root-cause analysis and verified for effectiveness. Risk-based assessment of all changes — facility, process, materials, suppliers — with regulatory impact evaluation. Senior management oversight of PQS performance, with structured quality metrics and trend reporting.

{/* Regulatory pillars */}

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{/* Quality systems */}

{QSYSTEMS.map((s, i) => { const Icon = s.icon return (

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{/* Validation lifecycle */}

{[ { n: '01', t: 'Process design (Stage 1)', d: 'Collect and synthesize knowledge from pharmaceutical development — defining CQAs, identifying CPPs, building the control strategy. Pilot-scale batches, design of experiments (DoE), and risk assessments establish the scientific basis for the commercial process.' }, { n: '02', t: 'Process qualification (Stage 2)', d: 'Facility, equipment and utility qualification (DQ, IQ, OQ, PQ), followed by Process Performance Qualification (PPQ) — successive batches executed under commercial conditions to demonstrate the process is reproducible and capable.' }, { n: '03', t: 'Continued process verification (Stage 3)', d: 'Ongoing monitoring of process performance and product quality throughout commercial production. Statistical process control, trend analysis, periodic product quality reviews (PQR), and continuous improvement actions.' }, ].map((s) => ( {s.d} ))}

{/* Data integrity deep dive */}

{[ { t: 'Attributable', d: 'Every data point can be traced to the individual who generated it — through signatures, electronic signatures and audit trails.' }, { t: 'Legible', d: 'Data is recorded in a permanent, readable form. Corrections are made with single-line strikethrough, signed and dated, retaining the original entry.' }, { t: 'Contemporaneous', d: 'Data is recorded at the time of the activity — not reconstructed from memory after the fact.' }, { t: 'Original', d: 'The first capture of data (or a true certified copy) is preserved. Electronic primary data is preferred where possible.' }, { t: 'Accurate', d: 'Data is correct, complete and truthful, with no errors or omissions. Methods and equipment are calibrated and validated.' }, { t: 'Complete', d: 'All data — including failed runs, repeats and investigations — is retained. No selective reporting.' }, { t: 'Consistent', d: 'Data is recorded in chronological order, with consistent formats and units, and follows defined procedures.' }, { t: 'Enduring', d: 'Data is recorded on durable media — validated electronic systems or archival-quality paper — and retained for the required period.' }, { t: 'Available', d: 'Data is retrievable throughout its retention period, for review by auditors, inspectors and authorized personnel.' }, ].map((d, i) => ( {`0${i + 1}`}

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{/* Continuous improvement */}

{[ { icon: TrendingUp, t: 'Trend analysis', d: 'Statistical process control charts, control limits and trend analysis on CQAs, environmental monitoring, deviations and complaints.' }, { icon: FileCheck, t: 'Product quality review', d: 'Annual PQR per EU GMP Chapter 1 and ICH Q7 — review of all batches, deviations, changes, complaints, stability and CAPA.' }, { icon: ShieldCheck, t: 'Management review', d: 'Senior management review of PQS performance metrics, with action items tracked to closure.' }, { icon: RefreshCw, t: 'PDCA cycle', d: 'Plan-Do-Check-Act applied to every improvement initiative, with documented effectiveness checks.' }, ].map((c, i) => { const Icon = c.icon return (

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Quality partnerships

Audits, inspections and quality agreements.

We welcome customer audits, regulatory inspections and third-party certifications. Quality agreements with every commercial partner define responsibilities, communication and escalation pathways. Contact our quality team for audit scheduling and quality agreement negotiation.

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