GUI-0036 : annex 13 to the Good manufacturing practices guide - drugs used in clinical trials. : H139-90/2025E-PDF

"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. …"--Purpose, page 4.

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