Maintenance of cost records: pharmaceutical companies must enable per unit costing and reconcile cost statements with audited financials.

Companies in the pharmaceutical industry must keep cost records per Proformae A-I each financial year to permit calculation of per unit production or operation costs, cost of sales and margins on a regular basis; maintain records in accordance with generally accepted cost accounting principles and applicable cost accounting standards with explained variations; ensure managerial control and supply required data; reconcile all cost records and statements with audited financial statements identifying excluded items and explaining variations; and preserve such records and reconciliations for the prescribed historical period, with responsible officers taking reasonable steps to secure compliance.

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