CERTIFICATIONS & COMPLIANCE
Bionial Lifesciences operates from a WHO-GMP certified, FSSAI licensed, and AYUSH GMP approved manufacturing facility in Mohali, Punjab. Every product that leaves our production line is backed by audit-ready documentation, pharmacopoeial testing, and internationally recognized quality credentials.
WHY CERTIFICATION MATTERS
In India's nutraceutical manufacturing landscape, certifications are not mere wall decorations — they are enforceable standards that directly impact your product's market access, consumer trust, and regulatory compliance. For brands launching health supplements, choosing a certified manufacturer is the single most important supply chain decision you will make.
WHO-GMP (World Health Organization Good Manufacturing Practices) certification ensures that a manufacturing facility follows globally harmonized quality standards for production, storage, distribution, and quality control. It covers everything from raw material sourcing and environmental controls to equipment validation and batch record integrity. For your brand, this means products that meet the same quality benchmarks expected in regulated international markets — not just domestic compliance minimums.
Beyond the regulatory advantage, certification communicates credibility to your customers, distributors, and retail partners. In an industry where consumer skepticism runs high, being able to say "manufactured in a WHO-GMP certified facility" on your label transforms perceived value and opens doors to premium positioning.
OUR CERTIFICATIONS
Each certification covers a distinct regulatory domain — together, they provide comprehensive compliance coverage for nutraceutical, dietary supplement, and Ayurvedic product manufacturing.
WHO-GMP certification confirms that our manufacturing facility meets the quality standards defined by the World Health Organization for pharmaceutical-grade production. This is the gold standard for any manufacturer intending to produce health products for domestic or international markets.
What it covers:
Why it matters to buyers: WHO-GMP certification is recognized across GCC countries, the UK, Africa, and select EU markets. Brands targeting export can use our certification to fast-track regulatory approvals in destination countries.
FSSAI (Food Safety and Standards Authority of India) licensing is mandatory for any entity involved in food manufacturing, processing, packaging, or distribution in India. Our FSSAI license covers the manufacture of dietary supplements, nutraceuticals, and health foods under the Food Safety and Standards (Health Supplements) Regulations, 2016.
License category permits:
Consumer protection: FSSAI licensing ensures every product meets safety standards for heavy metals, pesticide residues, microbial limits, and labelling accuracy — protecting both your consumers and your brand reputation.
AYUSH GMP certification, issued under the guidelines of the Ministry of AYUSH, enables Bionial to manufacture Ayurvedic proprietary medicines and classical formulations. This certification covers both patent (proprietary) and classical preparations as defined under the Drugs & Cosmetics Act, 1940.
Manufacturing scope includes:
CDSCO compliance: All Ayurvedic manufacturing follows the Central Drugs Standard Control Organisation guidelines, including proper licensing, batch-wise testing, and adverse event monitoring protocols as required for scheduled formulations.
CLIENT ADVANTAGE
When you manufacture with Bionial, you inherit our compliance infrastructure. Here is what that translates to in practical terms for your business.
Complete BMR (Batch Manufacturing Records), SOPs, validation protocols, and deviation logs maintained in audit-ready format. Your regulatory team can request any document at any time.
Every shipment includes complete batch documentation: Certificate of Analysis, batch manufacturing record summary, stability data (where applicable), and raw material traceability records.
All finished products are tested per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), or USP standards depending on your target market requirements. No generic in-house-only testing.
Accelerated stability studies (40°C/75% RH) and real-time stability data available for key formulations. Critical for shelf-life claims, export documentation, and regulatory submissions.
QUALITY INFRASTRUCTURE
Our quality infrastructure covers every stage from incoming raw materials to finished product release, ensuring consistent product quality across every batch.
Our in-house analytical laboratory is equipped with advanced instrumentation for comprehensive raw material and finished product testing. Every active ingredient is verified for identity, purity, and potency before batch release.
Critical quality parameters are monitored at every stage of production — from granulation and blending uniformity to compression, coating, and final packaging. Every checkpoint is documented and signed off by QC personnel.
Every batch shipped from our facility is accompanied by a comprehensive Certificate of Analysis. The CoA covers identity testing, assay (potency), heavy metals (As, Pb, Cd, Hg), microbial limits (TVC, yeast, mould, pathogens), and dissolution performance. CoAs are issued per pharmacopoeial standards applicable to your market.
For clients requiring independent verification, we facilitate third-party testing through NABL-accredited external laboratories. This is especially valuable for export orders, new product registrations, and brands requiring dual-source analytical validation for their quality files.
OUR PEOPLE
Our quality team brings decades of combined experience in pharmaceutical and nutraceutical quality assurance, analytical chemistry, and formulation development.
Oversees QMS documentation, deviation management, CAPA implementation, and regulatory audit readiness. 10+ years in pharmaceutical QA.
LinkedIn ProfileManages day-to-day analytical testing — HPLC method development, dissolution profiling, raw material release, and CoA generation for every batch.
LinkedIn ProfileLeads formulation development, excipient compatibility studies, stability protocol design, and technology transfer from bench scale to commercial production.
LinkedIn ProfileFREQUENTLY ASKED QUESTIONS
Yes. WHO-GMP certification is recognized internationally and accepted by regulatory authorities across GCC countries, the UK, and select EU markets. All batch documentation meets international export standards. Our certification enables seamless product registration in destination countries, and we provide all supporting documentation including site master files, product dossiers, and batch-specific CoAs formatted for international regulatory submissions.
Yes. Every batch is released with a comprehensive Certificate of Analysis (CoA) covering identity, assay, heavy metals, microbial limits, and dissolution testing per pharmacopoeial standards (IP/BP/USP). The CoA is generated by our in-house QC laboratory and signed by the Quality Manager before batch release. For export orders, we can also arrange third-party verification through NABL-accredited laboratories.
Yes. Bionial holds AYUSH GMP certification enabling manufacturing of both classical and patent Ayurvedic formulations, including Schedule E(1) herbs requiring special handling. Our Ayurvedic manufacturing wing follows all guidelines issued by the Ministry of AYUSH, and products are manufactured with full compliance to the Drugs & Cosmetics Act, 1940. We handle everything from sourcing authenticated raw herbs to final product testing.
Our QC laboratory is equipped with HPLC, UV-Visible spectrophotometer, dissolution apparatus, disintegration tester, Karl Fischer titrator, and stability chambers for accelerated and real-time studies. Additionally, we maintain calibrated balances, moisture analysers, friability testers, hardness testers, and microbiological testing facilities including a laminar air flow unit and incubation equipment for microbial limit testing.
We follow a documented OOS investigation procedure per WHO guidelines. Any OOS result triggers immediate quarantine, root cause analysis, retesting protocol, and corrective action before batch disposition. The investigation follows a phased approach: Phase I covers laboratory investigation (analyst error, instrument malfunction, sample preparation issues), and Phase II covers production investigation if laboratory causes are ruled out. No batch is released until the OOS is fully resolved and documented.
PARTNER WITH US
Whether you are launching a new supplement brand or scaling an existing product line, Bionial's certified manufacturing facility is ready to deliver. Get in touch to discuss your requirements.