20 Oct
|
Gladwin International
|
Hyderabad
20 Oct
Gladwin International
Hyderabad
Audit begins with product truth
In pharmaceutical manufacturing, the financial statements depend on a deeper record: whether materials were controlled, processes performed as approved, deviations investigated, data preserved and product released on sound evidence. The Audit Committee Chair must treat quality and data integrity as foundational to revenue, inventory, provisions, liability and licence to operate—not as a specialist presentation delivered after the accounts.
Assurance architecture
The Chair will align internal audit, quality assurance, statutory audit, compliance and enterprise risk so that gaps do not fall between their scopes. High-risk themes include batch and laboratory data, access and audit trails, deviations, out-of-specification results, change control, vendor qualification, stability, complaints, recalls, pharmacovigilance interfaces, computer-system validation and corrective-action effectiveness.
Management should report the age, recurrence and product/site consequence of observations.
Closure requires proof that root cause and control behaviour changed; a revised procedure or training record alone is weak evidence. The committee must be able to see where quality pressure, capacity or delivery incentives influence escalation.
Financial judgements beneath the operation
Inventory valuation and shelf life, rejected or quarantined stock, yield, scrap, product returns, customer claims, regulatory remediation, litigation, impairment and capitalised development require operating evidence. Revenue should be reconciled to release, shipment, acceptance and rights of return. Capital investment needs post-completion review against validated capacity, yield, compliance and actual cash benefit.
The Chair will also scrutinise related parties, distributor or customer credit, foreign exchange, tax positions and material third parties. Private sessions with external and internal auditors, the quality leader and the compliance officer should be routine when
📌 Independent Director (Hyderabad)
🏢 Gladwin International
📍 Hyderabad