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Division PART 2: CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL/MICROBIOLOGICAL INFORMATION (QUALITY)F1

United Kingdom

Original text. Later amendments are not shown.

All test procedures shall fulfil the necessary criteria for analysis and control of the quality of the starting materials and the finished product and shall be validated procedures. The results of the validation studies shall be provided. Any special apparatus and equipment which may be used shall be described in adequate detail, possibly accompanied by a diagram. The formulae of the laboratory reagents shall be supplemented, if necessary, by the manufacturing method.

In the case of test procedures included in the European Pharmacopoeia or the pharmacopoeia of a Member State, this description may be replaced by a detailed reference to the pharmacopoeia in question.

Where available, chemical and biological reference material of the European Pharmacopoeia shall be used. If other reference preparations and standards are used, they shall be identified and described in detail.

  1. AQUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS
  2. BDESCRIPTION OF MANUFACTURING METHOD
  3. CPRODUCTION AND CONTROL OF STARTING MATERIALS
  4. DCONTROL TESTS DURING THE MANUFACTURING PROCESS
  5. ECONTROL TESTS ON THE FINISHED PRODUCT
  6. FBATCH-TO-BATCH CONSISTENCY
  7. GSTABILITY TESTS
  8. HOTHER INFORMATION

Annotations

Textual amendments

F1

Substituted by Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance).