An investigational medicinal product must exist before a process can be defined as reconstitution. The process of reconstitution has to be undertaken as soon as practicable before administration. This process has to be defined in the clinical application / IMP dossier and clinical protocol, or related document, available at the site. Glossary: no changes, from the fact that the definitions of packaging’ and packaging’ from PE 009-8 Nil Nil ‘Immediate ‘Outer have been deleted in PE 009-10 as in practice these two terms were perceived as confusing because for non-investigational medicinal products the terms packaging’ and packaging’ are commonly used ‘primary ‘secondary Clauses 1 and 2: no change 3. All personnel involved with investigational medicinal 3. All personnel involved with investigational medicinal Additional Nil products should be appropriately trained in the products should be appropriately trained in the clarification on requirements specific to these types of product. requirements specific to types of product. situations of staff numbers, Even in cases where the number of staff involved is small, 4. The Authorised Person should in particular be which was there should be, for each batch, separate people responsible for ensuring that there are systems in place already required responsible for production and quality control. that meet the requirements of this Annex and should based on GMP therefore have a broad knowledge of pharmaceutical Chapter 2; 4. The Authorised Person should ensure that there are development and clinical processes. Guidance for the systems in place that meet the requirements of GMP and Authorised Person in connection with the certification of Correction of have a broad knowledge of pharmaceutical development and investigational medicinal products is given in paragraphs error changing clinical processes. Guidance for the Authorised Person 38 to 41. into ‘Annex’ in connection with the certification of investigational ‘GMP’ medicinal products is given in paragraphs 38 to 41.
An investigational medicinal product must exist before a process can be defined as reconstitution. The process of reconstitution has to be undertaken as soon as practicable before administration. This process has to be defined in the clinical application / IMP dossier and clinical protocol, or related document, available at the site. Glossary: no changes, from the fact that the definitions of ‘Immediate packaging’ and ‘Outer packaging’ from PE 009-8 have been deleted in PE 009-10 as in practice these two terms were perceived as confusing because for non-investigational medicinal products the terms ‘primary packaging’ and ‘secondary packaging’ are commonly used Nil Nil Clauses 1 and 2: no change 3. All personnel involved with investigational medicinal products should be appropriately trained in the requirements specific to these types of product. Even in cases where the number of staff involved is small, there should be, for each batch, separate people responsible for production and quality control. 4. The Authorised Person should ensure that there are systems in place that meet the requirements of GMP and have a broad knowledge of pharmaceutical development and clinical processes. Guidance for the Authorised Person in connection with the certification of investigational medicinal products is given in paragraphs 38 to 41. 3. All personnel involved with investigational medicinal products should be appropriately trained in the requirements specific to types of product. 4. The Authorised Person should in particular be responsible for ensuring that there are systems in place that meet the requirements of this Annex and should therefore have a broad knowledge of pharmaceutical development and clinical processes. Guidance for the Authorised Person in connection with the certification of investigational medicinal products is given in paragraphs 38 to 41. Additional clarification on situations of staff numbers, which was already required based on GMP Chapter 2; Correction of error changing ‘Annex’ into ‘GMP’ Nil
consult-manuf-automatic-adoption-pics-130529-comparison.docx