01
Market access.
WHO-GMP and applicable national GMP are statutory prerequisites for manufacturing and export in most jurisdictions. EU GMP, US cGMP, and PIC/S GMP define access to their markets.
Product & Regulatory
GMP — manufacturing practice, evidenced.
Good Manufacturing Practice programmes built around facility, process, and documentation discipline — for pharma, nutraceutical, cosmetic, and food manufacturers whose regulators and customers audit.
What it is
A family of manufacturing-practice frameworks, regulator-facing by design.
Good Manufacturing Practice is not a single standard but a family of regulatory and industry frameworks governing how regulated products are manufactured. WHO GMP, EU GMP, US cGMP (21 CFR 210/211 for pharmaceuticals), Schedule M of India's Drugs and Cosmetics Rules, ASEAN GMP, and ICH Q7 for active pharmaceutical ingredients all occupy this space. Food GMP is separately codified under CFR Title 21 Part 117 (US) and equivalent national frameworks.
The common thread is a requirement for controlled premises, validated processes, qualified personnel, documented batch records, and an inspection regime that regulators can — and do — enforce on site. A GMP certification or inspection clearance is regulator-facing evidence that a facility is fit to manufacture for the markets it targets.
Who needs it
Regulated manufacturers — pharma, nutraceutical, cosmetic, food.
Formulation and API manufacturers in pharmaceuticals; nutraceutical and dietary-supplement manufacturers; cosmetic manufacturers including personal-care; food manufacturers where GMP is a prerequisite for HACCP or ISO 22000; medical device manufacturers where ISO 13485 and applicable GMP (e.g. 21 CFR Part 820 / QMSR) overlap; and contract manufacturing organisations producing for brand-owner customers. Export-oriented manufacturers often pursue multiple GMP frameworks in parallel for market access.
Benefits
What a well-built BIFMA system earns you.
02
Inspection readiness.
A properly implemented GMP programme handles regulator inspections as routine events rather than existential crises.
03
Customer audit durability.
Brand-owner and contract-customer audits typically align with GMP requirements; an organisation that passes regulator inspection rarely struggles with customer audit.
04
Quality and batch consistency.
Process validation and in-process controls required by GMP materially reduce batch-to-batch variation and rework.
05
Data-integrity posture.
ALCOA+ data-integrity principles — attributable, legible, contemporaneous, original, accurate, and complete, consistent, enduring, available — are increasingly a regulator priority. GMP programmes make these explicit.
06
Platform for sector standards.
ISO 13485, 22000, WHO PQ, and similar programmes all sit on a GMP base. One good GMP implementation supports several downstream certifications.
Requirements, in outline
What the standard actually asks of you.
Substantive GMP requirements vary by framework but share common pillars. Premises and facilities: qualified design, appropriate classification of clean areas, environmental controls, utilities qualification, and segregation to prevent cross-contamination. Equipment: qualification (IQ/OQ/PQ), calibration, and maintenance. Personnel: training, hygiene, health surveillance, and competence management. Documentation: a hierarchy of site master file, standard operating procedures, batch manufacturing records, batch packaging records, and analytical method records.
Operational requirements cover materials management (incoming inspection, quarantine, release), production (line clearance, in-process controls, reconciliation), quality control (sampling, testing, stability), quality assurance (review and release), packaging and labelling, complaints and recalls, change control, deviation management, CAPA, self-inspection, and vendor qualification. Validation — process, cleaning, analytical method, computer system — is a substantial requirement area in its own right. Data integrity and electronic-records controls (21 CFR Part 11 in the US, EU GMP Annex 11 in the EU) are now consistently tested by inspectors.
Our approach
Five stages, from discovery to certificate.
01
Framework mapping
Identify the applicable GMP frameworks for intended markets — WHO, Schedule M, EU, US cGMP, ICH Q7 — and define the compliance target for the facility.
02
Facility & equipment readiness
Review facility design, classification, equipment qualification status, and utility qualification. Gap closure before documentation effort begins.
03
Documentation & validation
Site master file, SOP architecture, batch records, validation master plan, process and cleaning validation, analytical method validation, and computer system validation.
04
Self-inspection & readiness
Full self-inspection cycle including data-integrity review, mock regulator inspection, and gap closure.
05
Inspection & certification
For certified schemes (WHO-GMP, ISO 22716 for cosmetics), we attend the certification audit and support findings response. For regulator inspections, we coach the inspection response and front room.
Timeline & investment
Honest ranges, not placeholder pricing.
A well-designed facility with existing documented practice typically reaches inspection or certification readiness in four to six months. Greenfield facilities or facilities undergoing significant retrofit typically run to nine to twelve months, with validation activity driving the critical path.
Fees depend on facility scale, product complexity (sterile vs non-sterile, solid vs liquid, biologics, cytotoxic), and the frameworks in scope. Qualification and validation costs — including third-party testing — are typically larger than consultancy fees themselves.
Frequently asked
Questions we answer on most BIFMA calls.
No. ISO 9001 is a generic quality management-system standard; GMP is a regulatory framework with specific, enforceable requirements for regulated manufacture. A pharma facility needs GMP as a matter of law; ISO 9001 is additional and complementary.
WHO-GMP is the World Health Organization's baseline guidance for pharmaceutical manufacture, used in many developing-market regulatory regimes. Schedule M of India's Drugs and Cosmetics Rules is the Indian statutory GMP framework and was substantially updated in 2024 to align more closely with modern expectations, including data integrity and quality risk management.
FSSAI's nutraceutical regulations require GMP-compliant manufacture. Many nutraceutical manufacturers pursue ISO 22716 for cosmetics or WHO-GMP for supplements. The specific framework depends on product category.
Data integrity is now a major inspector focus. ALCOA+ principles govern how records are created, controlled, and retained. Electronic-record systems must be validated (21 CFR Part 11 / Annex 11 compliant), audit trails reviewed, and paper-hybrid practices managed carefully. Data-integrity failures have closed facilities.
Certification scheme scope can be limited to specific dosage forms or product lines. Regulatory inspection typically covers the facility as a whole, though specific product approvals reference specific lines. We set scope honestly; selective scoping to mask weaknesses is quickly detected.
Related services
Often pursued alongside BIFMA.
ISO 13485
A QMS aligned to medical device regulations across EU, US, Canada, Japan, and India.
Learn moreISO 22000
A food safety management system that integrates HACCP, PRPs, and management system discipline.
Learn moreHACCP
Seven-principle HACCP plans that survive regulator review and buyer audits.
Learn moreGet a readiness assessment for GMP.
Half a day with a senior consultant, a clause-level gap report, and a candid timeline. No commitment beyond the assessment itself.