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This Guide applies to the manufacture of APIs for medicinal products for both human and veterinary use. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered but should be performed in accordance with the principles and guidelines of GMP as laid down in national legislations and interpreted in the GMP Guide including its Annex 1.

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The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate, and do not place patients at risk due to inadequate safety, quality or
efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers, and by its distributors. To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Pharmaceutical Quality System should be adequately resourced with
competent personnel, and suitable and sufficient premises, equipment, and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Authorised Person(s).

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Harmonization will help ensure that there is a consistent view across inspectorates of what constitutes a “Critical” deficiency and what constitutes a “Major” deficiency. Risk management principles will be applied to the
categorisation of these deficiencies dependent on the type of product manufactured or process. The reference in the relevant code of Good Manufacturing Practice or local legislation should be established for each
deficiency to ensure that a reported deficiency has a regulatory basis and is accurately applied.

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this guideline describes questions and answers like;

  1. Are Health-Based Exposure Limits (HBELs) required for all medicinal products?
  2. Is there a framework that could be used to define the significance of the Health-Based Exposure Limit (HBEL) such that there can be broad guidance on the extent of Quality Risk Management (QRM) and control measures required?
  3. How should manufacturers use the HBELs?
  4. What competencies are required for the person developing the HealthBased Exposure Limits (HBEL)?
  5. What responsibility do contract givers have to contract manufacturers in relation to data to support a HBEL assessment?
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CMPs are issued in the framework of the World Health Organisation (WHO) certification scheme on the quality of pharmaceutical products moving in international commerce. According to such a scheme, the CMP is intended for use by the competent authority within an importing country when the product in question is under consideration for a product licence that will authorise its importation and sale and when administrative action is required to renew, extend, vary or review such a licence.

The procedures for authorisation and, consequently, certification of medicinal products in the European Union (EU) are complex. The objective of this document is to provide a brief and understandable summary of the arrangements.

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Once granted by the European Commission, the centralised marketing authorisation is valid in all EU and EEA-EFTA states (Iceland, Liechtenstein and Norway). This allows the marketingauthorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EEA.

This guideline describes following points;

  • How long does it take?
  • Which products must be centrally authorised?
  • Which products may optionally be centrally authorised?
  • Can I get pre-submission advice from the Agency?
  • How is my product evaluated?


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The primary objective of toxicokinetics is:

  • to describe the systemic exposure achieved in animals and its relationship to dose level and the time course of the toxicity study.

Secondary objectives are:

  • to relate the exposure achieved in toxicity studies to toxicological findings and contribute to the assessment of the relevance of these findings to clinical safety.
  • to support (Note 1) the choice of species and treatment regimen in non-clinical toxicity studies.
  • to provide information which, in conjunction with the toxicity findings, contributes to the design of subsequent non-clinical toxicity studies.
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This guideline extends and complements the “ICH Guideline on Safety Pharmacology Studies for Human Pharmaceuticals” (ICH S7A). This guideline applies to new chemical entities for human use and marketed pharmaceuticals when appropriate (e.g., when adverse clinical events, a new patient population, or a new route of administration raises concerns not previously addressed). Conditions under which studies are not called for are described in ICH S7A.

this guideline describes following points;

  1. Introduction
  • Objective of the Guideline
  • Background
  • Scope of the Guideline
  • General Principles

2. Guideline

  • Objectives of S7B Studies
  • Considerations for Selection and Design of Studies
  • Non-clinical Testing Strategy
  • Timing of S7B Non-clinical Studies and Integrated Risk Assessment in Relation to Clinical Development
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