Pharmaceutical Compliance Consulting

Every pharmaceutical plant in India is held to the Good Manufacturing Practices of Schedule M of the Drugs and Cosmetics Rules, and increasingly to WHO-GMP for exporters. An inspection is not a paperwork formality — it examines whether the facility is designed and operated to prevent contamination, mix-ups and errors: cleanroom classification and environmental monitoring, HVAC and air-change rates, water systems for purified water and water for injection, equipment qualification, and the validation of critical processes. A gap in any of these is a finding, and serious findings can suspend a licence or stop a product line.

The revised Schedule M has sharpened the focus on pharmaceutical quality systems, data integrity and computerised-system controls — areas where older plants most often fall short. We run a structured gap assessment against the current standard, translate the findings into a prioritised corrective plan, and help implement the documentation, validation and training needed to close them. The aim is a plant that passes not because it was tidied up for one visit, but because the systems behind it genuinely hold.

• Facility & utilities — cleanroom grades, HVAC, water systems, environmental monitoring.
• Quality systems — deviations, change control, CAPA, data integrity, batch records.
• Validation — process, cleaning, analytical method and computer-system validation.
• Documentation — Site Master File, SOPs, stability data, annual product reviews.

Most compliance failures are not caused by bad intent but by drift — a procedure that stopped being followed, a validation that lapsed, a record that was completed after the fact. Our approach front-loads the work: a mock audit that stress-tests the plant exactly as a regulator would, an honest gap report, and a remediation plan with owners and timelines. We then help build the missing systems — updated SOPs, validation protocols, training records — and rehearse the team so that when the real inspection comes, the facility, the documents and the people all tell the same consistent story.

For exporters, the stakes extend beyond the domestic licence to WHO-GMP certification and the Certificate of Pharmaceutical Product (CoPP) that overseas buyers and regulators demand. We prepare plants for these audits too, and support the ongoing obligations — stability programmes, annual product quality reviews, and prompt, well-documented responses to any observation — that keep certifications live rather than lapsing between audits.