new data. Justification for this should be documented and should take into account the requirements for retention of batch documentation; for example, in the case of process validation data, the accompanying raw data should be retained for a period at least as long as the records for all batches whose release has been supported on the basis of that validation exercise. The following section gives some examples of required documents. The quality management system should describe all documents required to ensure product quality and patient safety. 4.13 There should be appropriately authorised and 4.10 should be appropriately authorised and dated Requirement for Nil dated specifications for starting and packaging specifications for starting and packaging materials, and specs for all materials, and finished products. finished products; where appropriate, they should be also intermediates available for intermediate or bulk products. and bulks has been deleted as 4.15 now allows for a risk based approach to this requirement 4.14 Specifications for starting and primary or printed 4.11 Specifications for starting and primary or printed Inclusion of an Nil packaging materials should include or provide packaging materials should include, if applicable: option to put reference to, if applicable: references in A description of the materials, including: specifications A description of the materials, including: The designated name and the internal code The designated name and the internal reference; code reference;
new data. Justification for this should be documented and should take into account the requirements for retention of batch documentation; for example, in the case of process validation data, the accompanying raw data should be retained for a period at least as long as the records for all batches whose release has been supported on the basis of that validation exercise. The following section gives some examples of required documents. The quality management system should describe all documents required to ensure product quality and patient safety. 4.13 There should be appropriately authorised and dated specifications for starting and packaging materials, and finished products. 4.10 should be appropriately authorised and dated specifications for starting and packaging materials, and finished products; where appropriate, they should be also available for intermediate or bulk products. Requirement for specs for all intermediates and bulks has been deleted as 4.15 now allows for a risk based approach to this requirement Nil 4.14 Specifications for starting and primary or printed packaging materials should include or provide reference to, if applicable: A description of the materials, including: The designated name and the internal code reference; 4.11 Specifications for starting and primary or printed packaging materials should include, if applicable: A description of the materials, including: The designated name and the internal code reference; Inclusion of an option to put references in specifications Nil
consult-manuf-automatic-adoption-pics-130529-comparison.docx