Governance & responsibility

Environment, health and safety

Frameworks

Our environmental and occupational health and safety management systems are designed against ISO 14001 for environmental management and ISO 45001 for occupational health and safety, and against the applicable national environmental, factories and hazardous-waste legislation. We describe these as the frameworks the systems are built to; we make no claim of certification and depict no certificates.

Solvent selection

Solvents are selected against the ICH Q3C(R9) classification. Class 1 solvents are avoided by design rather than controlled by limit; Class 2 solvents are used only where no acceptable alternative exists and are controlled to their established limits with validated residual-solvent methods; Class 3 solvents are preferred. Solvent choice is a design decision taken with EHS at the table, not a downstream consequence.

Solvent handling

Bulk and drummed solvents are stored in a segregated, bunded, earthed and ventilated store away from production. Transfers into and out of process are closed or vapour-controlled wherever the operation allows; open charging points carry local exhaust ventilation. Hazardous areas are zoned with electrical equipment rated accordingly, flammable-vapour detection is installed and interlocked, and static control and bonding are verified as part of routine maintenance. Vapour is condensed and recovered in preference to being vented.

Air emissions

Process vents from solvent operations are condensed or scrubbed before discharge. Dust-generating solid-dose operations — dispensing, granulation, blending, compression, coating — are held under local extraction with filtration sized to the containment band of the material handled. Utility combustion sources are maintained and monitored on a defined schedule.

Effluent

Effluent is segregated at the point of generation. High-strength solvent-bearing and process-concentrate streams are collected separately and consigned to authorised off-site treatment, incineration or co-processing — they do not enter the drain. The remaining aqueous streams pass through the on-site treatment plant: equalisation, neutralisation, primary treatment and biological treatment, with monitoring before discharge to the designated route. Sludge is dewatered and consigned to authorised handlers. Stormwater is kept separate from process drainage throughout.

Waste segregation

Waste is separated by the person generating it, at the point it is generated, into hazardous, non-hazardous, recyclable and contaminated-sharps streams, in labelled and colour-coded containers held in designated areas. Solvent residues, contaminated packaging and laboratory chemical waste are consigned only to authorised handlers, under manifest, with returns reconciled. Rejected, returned and expired product is destroyed under quality supervision, witnessed, with the destruction recorded against the batch so the disposition can be reconstructed later.

Energy intensity

Sterile manufacture is energy-dense: cleanroom HVAC, pure-steam and WFI generation, chilled water and compressed air run continuously. Consumption is metered by utility and area and expressed as intensity per batch and per thousand packs, trended monthly and reviewed annually against a site reduction target. Improvement is pursued through recovery on distillation and steam systems, variable-speed drives, controlled setback of non-classified areas outside operating hours, and equipment replaced on efficiency at end of life. We publish no figures here; those we hold are illustrative of the facility standard and are reported through our partners' assessments, not as marketing claims.

Water intensity

Water is drawn for purified-water and WFI generation, for cleaning and for utilities. Withdrawal, reject and recycled volumes are metered separately and tracked as intensity per batch. Reverse-osmosis reject and selected rinse streams are recovered to non-product uses such as cooling make-up and washdown, and clean-in-place cycles are validated for the minimum water that still achieves the cleaning acceptance criteria — the constraint is always the cleaning result, never the saving.

Occupational health and safety

Active substances are assigned an occupational exposure band, and containment, ventilation and personal protective equipment follow from that band rather than from custom. Personnel handling potent compounds are enrolled in pre-placement and periodic health surveillance. Hot work, confined-space entry, work at height, line breaking and electrical isolation run under permit to work. Contractors work to the same permit system as employees. Incidents and near-misses are reported and investigated to cause, and the near-miss rate is treated as a health indicator rather than a problem to suppress.

Emergency preparedness

Solvent spill, fire, gas release and effluent-plant upset scenarios are identified, equipped for and rehearsed on a defined schedule, with the outcome of each drill recorded and acted on. Spill containment is provided where solvents are stored and transferred, and neighbouring emergency services are briefed on what the site holds.

Conduct, suppliers and personal data

• Code of conduct. One code applies to everyone who acts for Ergopharm — employees, officers, contractors, agents and distributors when acting on our behalf. It covers honesty in records and reporting, conflicts of interest declared before they bite rather than after, fair treatment and non-discrimination, confidentiality of partner information, and the plain rule that no commercial objective justifies a compromised quality decision.
• Anti-bribery and anti-corruption. We prohibit bribery in every form, direct or through an intermediary, in the public and private sector alike, and we prohibit facilitation payments without exception — including where they are locally customary. Gifts and hospitality are capped, declared and recorded in a register; payments to secure a registration, an import clearance, an inspection outcome or a tender award are forbidden and are grounds for dismissal and termination. Agents, consultants and distributors are subject to written due diligence before appointment and to contractual anti-bribery terms with audit rights and a right of termination. The programme is designed against the requirements of the UK Bribery Act 2010, the US Foreign Corrupt Practices Act and India's Prevention of Corruption Act 1988 as amended, with controls modelled on the ISO 37001 framework.
• Supplier code. Suppliers of active substances, excipients, primary packaging and outsourced services are qualified before use and work under written specifications and, where relevant, a quality agreement. Our supplier code sets expectations in four areas: GMP and data integrity for materials and services affecting product quality; environment, health and safety at the supplier's own site; labour standards — no forced, bonded or child labour, freedom of association, lawful working hours and wages, and a safe workplace; and business integrity on the same anti-bribery terms we hold ourselves to. We reserve the right to audit, we re-qualify on a risk-based cycle, and we require the code to be cascaded to sub-tier suppliers of critical materials.
• Trade and supply controls. Customers are screened before appointment and re-screened periodically, including against applicable sanctions and denied-party lists. Consignments of controlled substances are dispatched only against the import authorisations and licences the destination requires, on Incoterms 2020 terms agreed in writing, with shipping conditions and documentation defined before the first order. We do not appoint a distributor who will not accept the code, the audit right, or the obligation to pass adverse-event and quality reports back to us.
• Data protection. We collect the minimum personal data needed for the purpose at hand and keep it no longer than the purpose and our safety-reporting obligations require. This website carries no analytics, no advertising and no third-party embeds. Personal data is handled under India's Digital Personal Data Protection Act 2023 and the Digital Personal Data Protection Rules 2025, and, where personal data of individuals in the European Union is involved, under Regulation (EU) 2016/679. Safety data received through pharmacovigilance is held separately, under restricted access, and is not used for any commercial purpose. Full detail is in our privacy policy.
• Records and data integrity. GMP records — paper and electronic — are maintained to the ALCOA+ attributes, with individual system accounts, enabled and periodically reviewed audit trails, controlled changes, validated backup and defined retention. Falsifying, back-dating or selectively discarding a record is treated as a disciplinary matter of the most serious kind, whatever the result it was meant to produce.