Certifications &
Regulatory Excellence
Afro Pharmacy operates under the most rigorous international quality frameworks. Our India and Germany facilities are independently audited and certified to meet WHO-GMP, EU GMP, ISO standards, and ICH Q7 guidelines — ensuring every API batch meets the highest pharmaceutical grade requirements.
Globally Recognised Quality Standards
We maintain a comprehensive portfolio of certifications and accreditations that validate our commitment to pharmaceutical quality, environmental responsibility, and regulatory compliance.
WHO-GMP
India FacilityGood Manufacturing Practices certification from the World Health Organization — validating that our India site meets international standards for pharmaceutical manufacturing.
- Certified since 2022
- API manufacturing scope
- Regular surveillance audits
EU GMP
Germany FacilityEuropean Union Good Manufacturing Practice certification — our Germany facility is fully compliant with EudraLex Volume 4, enabling API supply to EU pharmaceutical markets.
- EMA-aligned standards
- Qualified Person (QP) release
- European reference site
ISO 9001:2015
Both FacilitiesQuality Management System certification covering all aspects of API development, manufacturing, quality control, and distribution across both sites.
- Process-based QMS
- Continuous improvement
- Customer focus
ISO 14001
Environmental ManagementCertified environmental management system — demonstrating our commitment to sustainable manufacturing, waste reduction, and solvent recovery.
- Green chemistry initiatives
- Effluent treatment compliance
- Carbon footprint reduction
ICH Q7
GMP for APIsFull adherence to the ICH Q7 guideline — the international standard for Good Manufacturing Practice guidance for Active Pharmaceutical Ingredients.
- API-specific GMP
- Change control & validation
- Traceability systems
USP / BP / EP
Pharmacopoeial GradesAll API products are manufactured and tested to meet the monographs of United States Pharmacopeia (USP), British Pharmacopoeia (BP), and European Pharmacopoeia (EP).
- Reference standard alignment
- Full compendial testing
- Certificate of Analysis provided
Dual-Site Certification Status
Each of our manufacturing hubs maintains independent certifications, providing regulatory flexibility and supply chain security for our global partners.
India Facility
Primary Manufacturing Hub · WHO-GMP
Germany Facility
European Hub · EU GMP
Quality Standards We Adhere To
Beyond certifications, our entire quality system is designed around internationally accepted pharmaceutical guidelines and best practices.
| Standard / Guideline | Scope | Status | Applicable Sites |
|---|---|---|---|
| ICH Q7 (GMP for APIs) | Active Pharmaceutical Ingredient manufacturing, packaging, and testing | Fully Implemented | India & Germany |
| ICH Q3A / Q3B (Impurities) | Control of organic impurities and degradation products | Compliant | India & Germany |
| ICH Q1A (Stability) | Long-term, intermediate, accelerated stability studies | Active Program | India & Germany |
| ICH Q6A (Specifications) | Setting acceptance criteria for new drug substances | Implemented | India & Germany |
| USP General Chapters | Residual solvents, elemental impurities, microbial limits | Routine Testing | India & Germany |
| EMA Guidelines | EU-specific API GMP and environmental risk assessment | Germany Facility | Germany |
| WHO TRS 986 (Annex 2) | WHO GMP for pharmaceutical products | India Facility | India |
Complete Documentation Packages
We support our clients’ regulatory filings with comprehensive, audit-ready documentation for each API batch.
- Certificate of Analysis (CoA) — Full compendial and non-compendial test results
- Safety Data Sheet (SDS) — Globally harmonised format
- Drug Master File (DMF) — Support for US, EU, and other regulatory submissions
- Stability Study Reports — ICH-compliant stability data
- Method Validation Packages — Full analytical method development reports
- Impurity Profiles — Characterisation of related substances and degradation products
Request Documentation
Need CoA, DMF support, or stability data for a specific API? Our regulatory team is ready to assist.
Request Documents →Third-Party Audits & Inspections
We welcome customer and regulatory audits at both our facilities. Our quality systems are designed for full transparency and traceability.
Open to Client Inspections
We regularly host quality audits from multinational pharmaceutical companies, veterinary drug manufacturers, and regulatory consultants.
- ✓ On-site or remote audit options
- ✓ Full document access (subject to CDA)
- ✓ Quality system walkthroughs
Proactive Compliance
Both facilities have successfully passed regulatory inspections by national authorities and notified bodies.
- ✓ WHO inspections (India site)
- ✓ German competent authority oversight
- ✓ ISO certification audits annually
Request Our Certification Package
Receive our complete certification portfolio, including current certificates, scope documents, and site-specific regulatory details.
Contact Quality Team →