QMS Consultant

Quality Management System Support

A robust Quality Management System (QMS) is the foundation of pharmaceutical compliance. I design and implement QMS solutions tailored to your specific operations—whether you're a small wholesaler or an established MAH. My approach focuses on building systems that are compliant, efficient, and scalable.

Rather than imposing unnecessary bureaucracy, I build practical systems that your team will actually use. Every procedure and process is designed with real-world operations in mind.

QMS Services

• Complete QMS design and architecture
• SOP development and review
• Quality risk management
• Deviation and CAPA management
• Document control systems
• Change control procedures
• Supplier qualification programmes
• Validation and qualification protocols

What a quality management system has to do

GDP Chapter 1 requires a documented quality system with defined responsibilities, processes and risk management. In practice that means a set of things that have to work together: procedures people actually follow, change control that catches changes before they happen rather than after, deviation and CAPA handling that closes properly, training records that match the roles people hold, self-inspection that runs to schedule, and management review that does something with the output.

The failure mode is rarely an absent system. It is a system that describes a company other than yours, because the procedures were inherited or bought and never reconciled with how the work is done.

Building, or repairing

A new WDA(H) applicant needs a system before the application goes in, because the MHRA will assess it. An established company more often needs specific parts strengthened after findings, or after growth has outrun the procedures written for a smaller operation.

Either way the first step is the same: establish what the system currently does, against what it is required to do. That is a GDP gap assessment, and it turns an open-ended project into a prioritised list.

Where the quality function itself is the gap, contract QA can cover it while the system is built. That model is explained in what contract QA is, and a working checklist of the areas involved is in the GDP compliance checklist.

Common questions

What does a pharmaceutical QMS have to cover?

For a wholesale dealer, the quality system has to cover documented procedures, defined responsibilities, change control, deviation and CAPA handling, quality risk management, training, self-inspection, and management review. GDP Chapter 1 sets the expectation; the detail depends on what your operation actually does.

Do we need a new QMS or can we fix the one we have?

Usually the second. Most companies have procedures; the gap is between what those procedures describe and what the business does. A gap assessment establishes which it is before anyone commits to rebuilding.

Will an off-the-shelf QMS template pass inspection?

A template gives you documents, not a quality system. Inspectors look at records rather than procedures, so a system that does not describe your actual operation tends to create findings rather than prevent them.

Does an eQMS solve this?

Software can make a working system easier to run and evidence. It does not decide what your processes should be, and implementing it over unclear processes tends to preserve the problem in a new format.

How does this relate to ISO 9001 or ISO 13485?

A GDP quality system and an ISO quality system share most of their structure. Where a company needs both, it is usually more efficient to design one system that satisfies both than to run two in parallel.

Official sources

• EU Guidelines on Good Distribution Practice (2013/C 343/01)
• MHRA — good manufacturing practice and good distribution practice
• Human Medicines Regulations 2012, Part 9

This page is general guidance, not regulatory advice. For advice on your specific situation, get in touch.