Annex 13 to the Good manufacturing practices guide for drugs used in clinical trials (GUI-0036): Overview

On this page

• Purpose
• Scope
• Introduction

Purpose

This guide is an annex to the Canadian Good manufacturing practices guidelines (GUI-0001). It applies to manufacturing, handling and storing of clinical trial drugs intended for use in clinical trials.

Good manufacturing practices (GMP) are internationally recognized standards that apply to drug manufacturing. They ensure drug quality and safety.

Drugs intended for use in clinical trials in Canada are regulated under Part C, Division 5 of the Food and Drug Regulations (regulations). Under section C.05.010(j), sponsors must ensure that drugs for use in clinical trials are manufactured, handled and stored in accordance with the applicable good manufacturing practices requirements referred to in Divisions 2 to 4. Exceptions are those requirements referred to in sections C.02.019, C.02.025 and C.02.026. Sponsors of clinical trials must also ensure that imported drugs are fabricated and packaged/labelled in accordance with these requirements.

The relevant sections of the regulations are noted throughout.

Retention Samples of the Drug

Although the regulations do not specifically state that samples of clinical trial drugs must be kept, in order to be able to fulfill Health Canada's request for a sample, as specified in this section, it is implicit that retention samples should be kept from the start of a clinical trial until the clinical trial report has been prepared.

Scope

This guide covers the manufacturing of human clinical trial drugs, placebo products and comparator products, which includes fabrication, packaging and labelling, and testing. It's relevant to anyone who works with such products as a:

• fabricator
• packager
• labeller
• tester
• sponsor

This document also includes guidance on ordering, shipping and returning clinical supplies.

Product categories covered by the guidelines include:

• human pharmaceuticals
• biologicals
• radiopharmaceuticals

Note: This guide is based on the Pharmaceutical Inspection Cooperation Scheme's (PIC/S) Annex 13 for the manufacture of investigational medicinal products (including changes necessary to adapt the text to meet Canadian requirements):

• Guide to good manufacturing practice for medicinal products annexes

For more information on clinical trial drugs, consult the following guidance documents:

• Part C, Division 5 of the Food and Drug Regulations "Drugs for clinical trials involving human subjects" (GUI-0100)
• Guidance document for clinical trial sponsors: Clinical trial applications

Introduction

Participants in clinical drug trials can be at higher risk of negative effects than people taking authorized drugs. The guidelines in this document are designed to minimize that risk.

Drug production for clinical trials is often more complex than for marketed products. Reasons for this include the following:

• no fixed routines/schedule
• clinical trial designs vary
• the need to randomize and blind participants

There may be incomplete knowledge of the potency and toxicity of the product and a lack of full process validation. The product specifications and manufacturing instructions may be changed during development, but full control and traceability of the changes should be documented and maintained.

As a result, producing drugs for clinical trials requires a highly effective quality system. The trial sponsor is responsible for all aspects of that system.

Note about guidance documents in general

Guidance documents like this one are not legally binding. They are administrative tools to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, ensuring that the rules enforced are fair, consistent and effective across Canada. This document is a guide to assess your compliance with the relevant GMP requirements for drugs used in clinical trials.

There is flexibility in how you meet the applicable laws and regulations. If you choose to follow an alternate approach to the principles and practices described in this document, you must provide adequate justification. Alternate approaches should be discussed in advance with the relevant program area. This helps ensure that your approach still meets all legal and regulatory requirements.

Health Canada may request additional information or material, or define conditions not specifically described in this document. These requests help us adequately assess compliance with the act and regulations. We are committed to making such requests only when necessary and to document our decisions clearly and transparently.

This document should be read along with the relevant sections of the regulations and other applicable guidance documents.

If there is a discrepancy between this guidance document and the regulations, the regulations always take precedence.