The document compares and contrasts quality systems requirements from 21 CFR 820, ISO 13845:2003, ICH Q10, and CGMP for combination products. It finds that 21 CFR 820, ISO 13845:2003, and CGMP show similarities in documentation control, design control, management responsibilities, corrective and preventive actions, and handling of nonconforming products. However, the standards also differ in areas like management responsibility requirements, additional clauses in ICH Q10, and additional drug-related requirements for combination products under CGMP.

1. QUALITY SYSTEMSComparison , differences and summaryPrepared and presented by,“QUALITEAM”AnkithDevunapalliDarshikaDoshiHarsh DharamshiSindhuraGaddamanuguSrikanth Reddy VattipalliQualiteam

2. ComparisonBased on:Similarities in requirements for the various aspects of a quality system.

3. Only those requirements that are similar in more than 2 of the assigned documents included in this sectionQualiteam

4. Qualiteam

5. Qualiteam

6. Qualiteam

7. Differences:Despite the similarities these quality systems differ from each other in several aspectsQualiteam

8. Guidance document for manufacturers of Combination pdts. as well as FDA

9. Guidance document for manufacturers of Combination pdts. as well as FDAQualiteam

10. Highly Defined

11. Requirements as mentioned in ComparisonApplicable as 21 CFR 820 for Medical Device as PMOARequirement as applicable to the type of productQualiteam

12. Included as a separate clause

13. Specific information regarding buildings, equipments and environment contamination control, manufacturing materials process validation automated processes control of inspection

14. Not included as a separate clause but included under resource management and product realization

15. No information regarding automated processes is provided

16. It is not included as a separate clause but some information provided under resourse management

17. No special requirements mentioned when compared to QSR and ISO Qualiteam

18. Included as a separate clause.

19. Information regarding Record Retention, device master records and device history records and complaint file is providedGeneral information regarding control of records is addressed under the clausedocumentation requirements.

20. DMR and DHR are not provided.

21. Feedback system in place of complaint files