Study Process Map

 

Quality

 

BLS maintains a comprehensive Quality Assurance Unite that includes experienced and well-trained QA professionals.
BLS conducts non-GLP studies in GLP-like quality. GLP-like means that our QA staff assures GLP compliance through operational audits.
Current and comprehensive SOPs, which undergo rigorous and frequent review, are key in assuring high quality. All studies and reports are inspected at periodic intervals and are thoroughly audited.


Final reports are generated according to the following regulations:

 

  •  Good Laboratory Practice Regulations enacted in Germany in the chemical Act (Chemikaliengesetz), current edition


  •  OECD Principles of Good Laboratory Practice Documents No 1 and 13


  •  FDA Good Practice Regulations 21 Code of Federal Regulations, Part 58, current edition

 
 
Time table

time table.jpg
 
Reporting

 

Comprehensive and concise reports are generated for all research programs by the dedicated and experienced Report Service department at BLS.

Final reports are generated according to the following regulations:

 

  •  Good Laboratory Practice Regulations enacted in Germany in the chemical Act (Chemikaliengesetz), current edition

  •  OECD Principles of Good Laboratory Practice Documents No 1 and 13


  •  FDA Good Practice Regulations 21 Code of Federal Regulations, Part 58, current edition


Final Reports include at least following contents

 

 

 

TABLE OF CONTENTS

 

1                    Statement of Compliance

2                    Quality Assurance Statement

3                    Abbreviations used in this Report

4                    Summary

            4.1       Conduct of Study 

            4.2       Observations

                        4.2.1     Imaging (x-ray, micro-CT, biofluorescence)       

                        4.2.2     Haematology 

                        4.2.3     Histology 

                        4.2.4     Histomorphometry

                        4.2.5     Biomechanic

            4.3       Conclusions 

 

5          General Informations

            5.1       Aim of study 

            5.2       Applicable guidelines 

            5.3       Study duration 

            5.4       Study sponsor

            5.5       Test facility 

            5.6       Test sites 

            5.7       Responsible persons 

            5.8       Time schedule and experimental phases 

            5.9       Data transfer to the sponsor

            5.10      Archives 

 

6          Deviations from the study plan

7          Materials and methods

            7.1       Test Materials 

            7.2       Identification of the Test Materials

            7.3       Test System  

            7.4       Experimental Design 

                        7.4.1     Animals 

                        7.4.2     Administration / Implantation / Autopsy 

                        7.4.3     Sample processing

                        7.4.4     Imaging 

                        7.4.5     Haematology 

                        7.4.6     Histology 

7.4.7     Histomorphometry

7.4.8     Biomechanics

 

8          Results and Discussion

            8.1       Clinical observations 

            8.2       Laboratory Examinations 

                        8.2.1     Image evaluation

                        8.2.2     Haematological evaluation

                        8.2.3     Histological evaluation

                        8.2.4     Histomorphometrical evaluation

                        8.2.5     Biomechanical evaluation          

8.3              Conclusions      

                                                          

9                    References

                       

10                Retention of Specimens 

                       

                       

11                Tables and Figures included in the report

 

12        Tables and Figures not included in the report

            12.1      Individual animal weight on arrival and at the start of in-life phase

            12.2      Hematology test site results

            12.3      Images

            12.4      Histology

            12.5      Histomorphometry

            12.6      Biomechanics

            12.7      Schematic Presentation of Implantation Site

12.8      Method for Implantation Site Preparation

 

13        Appendices

            13.1      Standard operating procedures

            13.2      Test material certificate of analysis

            13.3      Diet composition

            13.4      Drinking water composition

            13.5      List of imaging documents

            13.6      List of histological and histomorphometrical samples