Quality, Safety & Regulatory Compliance

MHRA Authorised Distribution • Licence Number: UK WDA(H) 56111

At SUPER B PLUS GROUP LTD®, patient safety, product efficacy, and strict regulatory compliance are at the heart of everything we do. We operate under strict regulatory oversight from the Medicines and Healthcare products Regulatory Agency (MHRA) and are fully authorised under Wholesale Distribution Authorisation Licence: UK WDA(H) 56111.

Our operations strictly adhere to the Guidelines on Good Distribution Practice (GDP) of medicinal products for human use, ensuring complete traceability, quality preservation, and cold-chain integrity from manufacturer to patient.

🛡️ Our Core Compliance & Temperature Framework

1. Multi-Zone Temperature Control (Ambient, Cold-Chain & Frozen)

Many life-saving therapeutics, vaccines, and specialized clinical formulas require strict, unbroken temperature management to retain their molecular integrity. We manage these lines in highly regulated, continuously validated climate environments:

  • Frozen & Ultra-Low Sourcing: Equipped to safely secure, handle, and distribute specialized low-temperature and frozen medical lines.

  • Cold-Chain Management: Continuous storage and dispatch within a strict, monitored 2°C to 8°C climate envelope.

  • Controlled Ambient: Secure warehousing and shipping within a regulated 15°C to 25°C range to prevent temperature excursions.

2. End-to-End Batch Traceability

We operate a zero-tolerance policy for diverted, counterfeit, or falsified medicines.

  • FMD Alignment: Full alignment with the Falsified Medicines Directive (FMD) validation and decommissioning protocols where applicable.

  • Rigorous Chain of Custody: Every container, vial, and box in our care is logged with complete transaction histories, original purchase orders, and manufacturer batch numbers.

3. Dedicated Quality Management System (QMS)

Our sourcing operations are governed by a live, agile Quality Management System (QMS) continuously updated by our compliance officers.

  • SOP Enforcement: Highly structured Standard Operating Procedures (SOPs) cover all aspects of procurement, receipt, storage, deviation reporting, corrective/preventative action (CAPA), and rapid recall procedures.

  • Routine Audits: Constant internal auditing of storage facilities, supply routes, and partner networks ensures we always remain audit-ready.

📥 Onboarding & Verifications

If you are a manufacturer, clinical trial sponsor, community pharmacy group, or NHS trust preparing to establish a trade account with us, please use our quick-access regulatory paths below: