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 SYSTEMS Comparison , differences and summary Prepared and presented by, “QUALITEAM” AnkithDevunapalli DarshikaDoshi Harsh Dharamshi SindhuraGaddamanugu Srikanth Reddy Vattipalli Qualiteam

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

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

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

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

20. DMR and DHR are not provided.

21. Feedback system in place of complaint files

22. No Q10 equivalentQualiteam

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28. Manufacturer should identify and distinguish returned medical devices from conforming productsNo special requirements are mentioned Qualiteam

30. Manufacturer should establish, maintain and document procedures to ensure proper handling, storage,Distributionand installation of the product to avoid mix-ups , damage ,contamination and adverse effects.It is not described in detail when compared to QSR There is no special requirements Qualiteam

32. Particular requirement for active implantable medical devices and implantable medical devices is neededThere is no special requirements Qualiteam

34. knowledge management

35. management of change in product ownership.

36. Each and every clause specified special requirements at different stages of product life cycle.Qualiteam

37. SUMMARY: 21 CFR 820, ISO 13845:2003 and CGMP show similarities in documentation control ,design control management responsibilities , corrective and preventive actions and nonconforming products. 21 CFR 820 and ISO 13845:2003 mention similar requirements under purchase controls with CGMP’S showing the same with respect to medical devices. Labeling and packaging control is another clause where 21 CFR 820 and CGMP’S show similar requirements. CGMP for combination products ,ISO 13485:2003 and 21 CFR 820 also mention the same requirements for handing, storage, distribution and installation. Qualiteam

38. The differences are listed below: 21 CFR 820: no requirements for planning, internal communication, product realization and its planning and absence of special requirements for sterile medical devices and customer related processes. ISO 13845:2003 : mentioned additional requirements under management responsibility which include management commitment, customer focus, review output and input, no requirements with respect to DMF, automated process, distribution, labeling and packaging. ICH Q10: no special requirements for documentation control, identification and traceability , labeling and packaging., handling ,storage, distribution and installation in Q10. Non conforming products were not given special requirements under Q10. Their handling was mentioned under corrective and preventive actions. Also there was no mention of verification and validation and management review under corrective and preventive actions in Q10. Purchase controls were not highly defined. Certain requirements were found exclusively in Q10. Emphasis was made on quality risk management, knowledge management and management of change in product ownership. Each and every clause specified special requirements at different stages of product life cycle. CGMP for combination products : when regulated by 21 CFR 820 ,additional requirements as per 21 CFR 210 and 211 which include drug product inspection , expiration dating , testing and release for distribution ,stability testing , reserve samples and testing and approval or rejection of components , drug product containers and closure are considered . When regulated by 21 CFR 210 and 211 , additional requirements like design controls , purchasing controls, corrective and preventive actions are considered Qualiteam