Purpose

This Quality Manual provides an overview of what Temperature Controlled Distribution Ltd (TCD) does, its quality policy, management responsibilities, and an overview of the Quality Management System (QMS).

Scope

This manual applies to all TCDs operational activity and is provided to customers for information purposes only.

All TCD policies and procedures must conform to this manual.

About TCD

Temperature Controlled Distribution Ltd (TCD) was created in 2018 when a group of individuals who had been providing distribution services to a nationwide pharmacy for a combined 25 years, merged to form one company.

TCD's primary purpose was to support the rapid growth of Baxter Healthcare @ Home by providing high quality, reliable and efficient delivery services via Polar Speed.

TCD have a person focused approach and provide a flexible, dedicated and dynamic service. We have gained the trust of Pharmacists, Business Managers and Patients alike and this is something we strive to always develop in and improve on.

We strive to establish strong and trustworthy relationships with patients, and family members, which ensures smooth transitions when delivering pharmaceutical products and installing hospital equipment safely into people’s homes.

In 2025 we expect to expand our business to provide all elements of homecare pharmacy services as a supplier to NHS procurement teams and hospitals across the UK.

What does TCD do?

TCD provides medicines transportation services to patients and hospitals on behalf of third-party clients who are MHRA and/or GPhC license holders.

TCD intends to provide Homecare pharmacy services for NHS customers under our MHRA WDA and GPhC pharmacy licenses. This includes:

• Purchasing and storage of medicines
• Dispensing and supply of medicines to patients
• Outsourced activities including clinical services

Quality Policy

TCD earns customer loyalty by consistently meeting or exceeding their expectations while helping advance health and wellness. We continuously improve our quality systems and provide high-quality products, services and solutions that:

• Are safe and effective
• Comply with all applicable laws and regulations
• Satisfy our customers

Organisational Chart & Responsibilities

Our Organisation

3.2 Leadership

Establish and maintain the Quality Manual including Quality Policy and communicating a culture that promotes Quality

Ensure adequate facilities, resources, including staff, training and equipment, are available to implement the QMS and effectively support quality goals.

Regularly review the QMS performance, through a Quality Management Review, approve quality updates, and communicate quality objectives to the wider team.

Ensure staff are aware of the Quality Policy; Objectives; their required contribution to the effectiveness of the QMS.

Ensures that company objectives and strategy are consistent with the Quality Policy.

Quality Manager

Oversee the development, implementation, maintenance, and continuous improvement of the QMS, ensuring it meets regulatory and organizational standards.

Plan, execute, and review internal audits to identify gaps and areas for improvement in the QMS.

Provide training to staff on QMS processes, regulatory changes, and quality initiatives.

Report on the QMS’s effectiveness, non-conformances, and improvement initiatives to senior management.

Staff

All staff are responsible for complying with the policies and procedures outlined in the QMS. This includes:

• Identifying and reporting quality issues and risks
• Participating in continuous improvement
• Maintaining records

Additional responsibilities are described in job descriptions, SOPs and in the rest of this section.

Quality Management System (QMS)

Overview

The QMS ensures that TCD meets regulatory requirements and good practice recommendations, delivery on our quality policy and maintain high quality standards throughout our business. It includes:

• Documented procedures for all critical activities
• Regular audits to ensure compliance
• A focus on continuous improvement based on CAPA (Corrective and Preventive Actions)
  
  

It applies personnel, procedures, activities, and processes related to the wholesale distribution of medicinal products at TCD. It includes but is not limited to warehousing, order processing, product handling, transportation, and distribution of medicines within the UK and internationally, as permitted under our MHRA WDA license.

It also includes homecare pharmacy activity including supply of medicines to patients as permitted under a GPhC pharmacy license.

This does not apply to business strategy, financial goals and clinical matters that are not specified explicitly in procedures.

• An overview of processes and their objectives are provided below. Further details can be found in individual processes – see appendix for documentation index.

Quality Management Processes

Management Review

Management reviews are conducted quarterly to assess the effectiveness of the QMS, review audit findings, assess CAPAs, and monitor overall compliance with GDP. The management review also includes setting objectives for continuous quality improvement and ensuring the Quality Policy is deployed.

Quality Audit

Verifies compliance to the QMS. Audit findings are documented, with corrective actions implemented and reviewed by senior management.

Risk Management

Implements a systematic and consistent process for identifying, assessing, mitigating and monitoring risks related to quality and compliance of products and services.

Quality Processes

Documentation Control

Ensures that all quality documents, including SOPs, work instructions and forms, are controlled and managed in the QMS.

Documents are created and maintained according to clearly defined SOP and are stored securely and accessible to authorised personnel.

Regular review and approval of documents are carried out by the Responsible Person, Quality Manager, Senior Management, Responsible Pharmacist and Superintendent Pharmacist as appropriate.

Personnel Training and Competency

Ensures that all personnel are trained in TCD processes, are qualified for their job role and training records are maintained.

Supplier and Customer Qualification

Ensures suppliers are evaluated, approved, and regularly assessed to ensure compliance with quality and regulatory standards.

Ensures that customers are authorised to receive products and services from TCD. to ensure the legitimacy of product distribution.

Complaints, Returns, and Recalls

Ensures a robust complaint, return, and recall management system is in place to handle issues promptly and in compliance with GDP and pharmacy requirements where applicable. Affected products are quarantined, and root cause analyses are conducted to prevent recurrence.

Deviation and CAPA Management

Enhance processes by ensuring that deviations from SOPs are recorded, investigated, and followed by corrective and preventive actions (CAPA). CAPA plans are documented, reviewed, and monitored.

Change Control

Ensures that changes to processes, systems, or facilities that impact product quality are managed through a formal change control process. This includes risk assessment, impact analysis, and appropriate approvals.

Distribution and Supply Processes

Storage and Handling

Ensures that products are stored and handled in accordance with GDP guidelines, with dedicated zones for receiving, quarantine, approved stock, and rejected materials. Storage areas are monitored continuously to ensure products are kept within the required temperature ranges.

Transport and Distribution

Ensures that product integrity is maintained throughout the distribution process.

Pharmacy processes

Ensures that responsibilities for pharmacy processes are defined and ensures that medicines are dispensed and supplied to patients in accordance with GPhC regulations and in accordance with homecare pharmacy services specifications.

Documentation Types

Document Type	Objective
Quality Manual	Contains a description of the QMS and its processes including the Quality Policy, scope of the QMS and management responsibilities
Standard Operating Procedure (SOP)	Give instructions on what steps need to be completed to successfully carry out an operation
Work Instruction (WI)	Give detailed step by step instructions on how to perform specific task(s)
Form	Provide a standardised method for capturing data