Guide to Good Manufacturing Practice Volume IV of Rules Governing Medicinal Products in the European Community

Guide to Good Manufacturing Practice Volume IV of Rules Governing Medicinal Products in the European Community.

Where the guides to good hygiene practice referred to in paragraph 1 are developed, they shall be developed as follows:

Member States shall forward to the Commission those guides to good hygiene practice which they presume to comply with Article 3.

whereas this Directive does not therefore impose observance of guides to good hygiene practice, which have no legal force;

ensure that the relevant guides to good hygiene practice drawn up in accordance with paragraphs 1 to 3 are taken into account,

the need for the producing establishment to be in full conformity with the guidelines for good manufacturing practices (GMP);

In developing the European guides to good hygiene practice referred to in paragraph 6, all necessary measures shall be taken in order to:

Current version of the 'Guide to good manufacturing practice', Volume IV of Rules governing medicinal products in the European Community.

In doing so, due consideration shall be given to the guides to good hygiene practice referred to in Article 5 of this Directive, where they exist.

The latest version of the 'Guide to good manufacturing practice', Volume 4 of the rules governing medicinal products in the European Union and amendments thereto

Member States shall assess the guides to good hygiene practice referred to in paragraphs 1 and 2 with a view to determining the extent to which they may be presumed to comply with Article 3.

Council Directive of 31 March 1992 on the wholesale distribution of medicinal products for human use (92/25/EEC) (OJ L 113, 30.4.1992. p. 1) and Guide to Good Distribution Practice

Member States shall encourage the development of guides to good hygiene practice which may be used voluntarily by food businesses as a guide to compliance with the provisions of Article 3.

Whereas, in order to have the general rules of hygiene for foodstuffs and the guides to good hygiene practices implemented, the application of standards of the EN 29000 series should be recommended;

Unless specific definitions are given, the definition of terms in the "OECD principles of good laboratory practice" (Annex II to OECD Council Decision (C(81)30(final)), the "Guides for compliance monitoring procedures for good laboratory practice" (Annex I to Council Decision-Recommendation (C(89)87(final)), the "Application of the good laboratory practice principles to field studies" (GLP consensus document, OECD series on principles of good laboratory practice and compliance monitoring), and all amendments made thereto shall apply.

Where one or more Member States, or the Commission, consider that, for the purposes of harmonization, there may be a need for guides to good hygiene practice to be developed on a European basis (hereafter referred to as 'European guides to good hygiene practice'), the Commission shall consult Member States in the framework of the Standing Committee on Foodstuffs in accordance with Article 14. The object of this consultation shall be to consider the case for such voluntary guides in the sectors or activities concerned, and, where such guides are considered necessary:

Whereas Member States shall encourage and participate in the development of guides to good hygiene practice to which food businesses may refer, based, where appropriate, on the Recommended International Code of Practice, General Principles of Food Hygiene of the Codex Alimentarius (4);

As part of the internal approach referred to in paragraph 1, establishments may use guides of good manufacturing practice drawn up by appropriate professional organizations and acceptable to the competent authorities.

Whereas the Commission, assisted by Member States and other interested parties, is to encourage the development of guides to good hygiene practice to which food businesses may refer where necessary throughout the Community;

The titles and references of European guides to good hygiene practice developed in accordance with the procedure in paragraphs 6 and 7 shall be published in the C series of the Official Journal of the European Communities.

Member States shall, if they consider it appropriate, recommend food business operators to apply the European Standards of the EN 29000 series in order to implement the general rules of hygiene and the guides to good hygiene practice.

Unless specific definitions are given, the definition of terms in the "OECD Principles of Good Laboratory Practice" [Appendix II to OECD Council Decision of 12 May 1981 C(81)30(Final)], the "Guides for Compliance Monitoring Procedures for Good Laboratory Practice" [Appendix I to Council Decision-Recommendation of 2 October 1989 C(89)87(Final)] and GLP Consensus documents, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, and all amendments made thereto, shall apply.

The principles and guidelines of good manufacturing practice for veterinary medicinal products referred to in Article 50(f) shall be adopted in the form of a Directive addressed to the Member States in accordance with the procedure referred to in Article 89(2).

When not taken from regulatory standards (e. g. frozen storage temperature) or from existing and validated guides of good manufactoring practices, the team should ascertain their validity relative to the control of identified hazard and critical points.

(2) Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use fn is to be incorporated into the Agreement.

The provisions for the inspection and verification of GLP which are contained in parts A and B are those contained in Annexes I (Guides for compliance monitoring procedures for good laboratory practice) and II (Guidance for the conduct of test facility inspections and study audits) respectively of the OECD Council Decision-Recommendation on compliance with principles of good laboratory practice [C(89)87(Final)] of 2 October 1989 as revised by the OECD Council Decision amending the Annexes to the Council Decision-Recommendation on compliance with principles of good laboratory practice of 9 March 1995 [C(95)8(Final)].

For the purpose of this Sectoral Annex, any term, unless otherwise defined in this Agreement, has the meaning assigned to it in the 'OECD Principles of good laboratory practice' as contained in Annex II of the OECD Council Decision of 12 May 1981 (C(81)30(final)), the 'Guides for compliance monitoring procedures for good laboratory practice' as contained in Annex I of the OECD Council Decision - Recommendation of 2 October 1989 (C(89)87(final)), the GLP Consensus Document 'The Application of the GLP Principles to Field Studies' (OECD Series on Principles of good laboratory practice and compliance monitoring, Number 6), and all amendments made thereto.

The officials representing the competent authority shall report after each of the inspections mentioned in the first paragraph on whether the manufacturer complies with the principles and guidelines of good manufacturing practice referred to in Article 51. The inspected manufacturer shall be informed of the content of such reports.

guidelines on information and guides to good practice for the public;

As part of the system referred to in paragraph 1, operators of meat establishments may use guides to good practice that have been assessed by the competent authority.

Guide to Good Distribution Practice

Guide to Good Distribution Practice (94/C63/03)

to comply with the principles and guidelines of good manufacturing practice for medicinal products as laid down by Community law.

Current version of the Guide to Good Manufacturing Practice, Rules Governing Medicinal Products in the European Community, Volume IV

Current version of the 'Guide to good manufacturing practice`, Volume IV of Rules governing medicinal products in the European Community.

"(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials.

For the interpretation of these principles and guidelines of good manufacturing practice, the manufacturers and the agents of the competent authorities refer to the detailed guidelines referred to in Article 27a of Directive 81/851/EEC.

supporting and promoting activities by the Community and the Member States with regard to good practice and to sound guidelines for public health based on scientific data.

Detailed guidance on the elements to be taken into account when evaluating products with the object of releasing batches within the Community shall be drawn up pursuant to the good manufacturing practice guidelines, and in particular Annex 13 to the said guidelines.

Where one or more Member States, or the Commission, consider that, for the purposes of harmonization, there may be a need for guides to good hygiene practice to be developed on a European basis (hereafter referred to as 'European guides to good hygiene practice'), the Commission shall consult Member States in the framework of the Standing Committee on Foodstuffs in accordance with Article 14.

Within 90 days of an inspection as referred to in paragraph 1, a certificate of good manufacturing practice shall be issued to a manufacturer if the outcome of the inspection shows that the manufacturer complies with the principles and guidelines of good manufacturing practice as provided for by Community legislation.

Within 90 days after an inspection as referred to in paragraph 1, a certificate of good manufacturing practice shall be issued to the manufacturer if the inspection established that the manufacturer in question is complying with the principles and guidelines on good manufacturing practice as provided for by Community law.

This Directive lays down the principles and guidelines of good manufacturing practice for veterinary medicinal products whose manufacture requires the authorization referred to in Article 24 of Directive 81/851/EEC.

The principles and guidelines of good manufacturing practices for medicinal products referred to in Article 46(f) shall be adopted in the form of a directive, in accordance with the procedure referred to in Article 121(2).

The principles of good clinical practice and detailed guidelines in line with those principles shall be adopted and, if necessary, revised to take account of technical and scientific progress in accordance with the procedure referred to in Article 21(2). These detailed guidelines shall be published by the Commission.

The contract acceptor shall respect the principles and guidelines of good manufacturing practice and shall submit to inspections carried out by the competent authorities as provided for by Article 34 of Directive 81/851/EEC.

In order to ensure conformity with the principles and guidelines of good manufacturing practice, it is necessary to lay down detailed provisions on inspections by the competent authorities and on certain obligations of the manufacturer.

By means of the repeated inspections referred to in Article 34 of Directive 81/851/EEC, the Member States shall ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive.

All medicinal products for human use manufactured or imported into the Community, including medicinal products intended for export, are to be manufactured in accordance with the principles and guidelines of good manufacturing practice.