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Regulatory Affairs

Active Substance Guidelines:

Guideline on Summary of requirements for active substances in the quality part of the dossier

Guidance for the template for the qualified person’s declaration concerning GMP compliance of active substance manufacture “The QP declaration template”

European Pharmacopoeia

EMA

Medicinal Product Guidelines – Manufacturing

Guideline on manufacture of the finished dosage form

Guideline on process validation for finished products - information and data to be provided in regulatory submissions

Medicinal Product Guidelines – Impurities

Guideline on control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “substances for pharmaceutical use” and general chapter “control of impurities in substances for pharmaceutical use”

ICH Q3B (R2) Impurities in new drug products

ICH Q3C (R8) on impurities: guideline for residual solvents

ICH Q3D (R1) on elemental impurities 

Medicinal Product Guidelines – Specifications, analytical procedures and analytical validation

ICH Q6A - Note for Guidance and specifications – Test procedure and acceptance criteria for new drug substances and new drug products – Chemical substances

Specifications and control tests on the finished product

ICH Q2 (R1) Validation of analytical procedures: Text and methodology

Medicinal Product Guidelines – Excipients

Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product

Guideline on the quality of water for pharmaceutical use

Medicinal Product Guidelines – Packaging

Guideline on plastic immediate packaging materials

Medicinal Product Guidelines – Stability

Guideline on stability testing: Stability testing of existing active substances and related finished products

ICH Q1B - Stability testing: photostability testing of new drug substances and products

ICH Q1E - Evaluation of stability data

Guideline on declaration of storage conditions

Note for Guidance on in-use stability testing of human medicinal products

Note for Guidance on start of shelf-life of the finished dosage form

Medicinal Product Guidelines – Pharmaceutical development

Guideline on plastic immediate packaging materials

ICH guideline Q8 (R2) on pharmaceutical development

ICH Q10 on pharmaceutical quality system

ICH Q8, Q9 and Q10 – questions and answers volume 4

Note for Guidance on development pharmaceutics

Medicinal Product Guidelines – Specific types of products

Guideline on the pharmaceutical quality of inhalation and nasal products

Medical Devices

Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

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