Quality & Documentation Hub

Distributors are risk managers. We make quality proof simple, accessible, and complete β€” so you can import cleanly, register confidently, and trust every batch.

GMP-Certified Manufacturing

Pharmacare operates under Good Manufacturing Practice (GMP) standards aligned with WHO guidelines. Every product in our portfolio is manufactured, tested, and released under a rigorous quality management system.

We understand that for a distributor or importer, our quality documentation is as important as the product itself. Registration authorities, tender committees, and hospital procurement boards all require verifiable quality proof β€” and we provide it.

Our Quality Assurance team handles documentation requests alongside every order, ensuring you receive everything you need before shipment.

WHO GMP Standards

Manufacturing processes and facilities comply with World Health Organization Good Manufacturing Practice guidelines.

ISO Quality Systems

Quality management systems aligned with international ISO standards for pharmaceutical manufacturing.

Batch-Level Traceability

Every batch is fully traceable from raw material sourcing through manufacturing, QC testing, and release.

Everything You Need to Import and Register

We provide a complete documentation package with every order. Below is what we offer, what it covers, and how to request it.

Certificate of Analysis (CoA)

Issued per batch confirming that the product meets all specified quality parameters including identity, purity, potency, and physical characteristics.

  • Issued: Per batch, upon request
  • Format: Official company letterhead
  • Covers: All finished product categories

Material Safety Data Sheet (MSDS)

Provided for all API and chemical products, detailing handling, storage, hazard classification, and emergency information.

  • Issued: Per product/API
  • Format: GHS-compliant
  • Covers: All API products

Batch Release / QC Records

Official batch release documentation confirming that each batch has passed all QC testing and is approved for distribution.

  • Issued: Per batch
  • Format: Internal QA sign-off
  • Covers: All product categories

Stability Overview

Stability data confirming shelf life under defined storage conditions. Essential for import registration and tender submissions.

  • Format: Summary or full data
  • Conditions: ICH Zone IVb (tropical)
  • Available for: Key product lines

Dossier / CTD (on request)

Common Technical Document (CTD) dossiers available for selected products to support national registration processes across African markets.

  • Format: CTD / ACTD format
  • Availability: Selected products
  • Enquire: Via RFQ form

GMP Certification

Official GMP certificate available for tender submissions, registration authorities, and distributor due diligence requirements.

  • Issued by: Regulatory authority
  • Scope: Manufacturing site
  • Available: Upon request

Documentation FAQs

Standard documentation (CoA, batch release) is prepared alongside your order and delivered before or with shipment. Dossiers and special documentation packages may require additional lead time β€” please specify your requirements in your RFQ.

Yes. Our manufacturing standards and documentation are designed to support registration across African regulatory frameworks including NAFDAC (Nigeria), KEBS/PPB (Kenya), SAHPRA (South Africa), and others. We can advise on documentation requirements for specific countries.

Yes. Stability studies are conducted under ICH Zone IVb conditions (30Β°C / 75% RH), which represent tropical and subtropical climates common across African markets. This data is available for key product lines.

Every batch undergoes full in-process and final QC testing including identity confirmation, assay, dissolution (where applicable), microbiological testing, and physical inspection before batch release. No product ships without QA sign-off.

Sample availability varies by product. Please submit a sample request via our RFQ form specifying the product, intended market, and purpose. Our team will advise on availability and logistics.

Need a Documentation Package?

Tell us the products and your destination market and we'll prepare a complete documentation overview for you.