List of Documents and SOPs for Food Drug Authority (FDA)

The list of Documents and SOPs are as follows:

1. STANDARD OPERATING PROCEDURE FOR ARCHIVING THE DOCUMENTS AND SUBSTANCES

2. STANDARD OPERATING PROCEDURE FOR DISPOSAL OF ARCHIVED MATERIAL

3. State FDA inspections following points should be considered In India for Laboratory Animal Facilities.

4. Drug and Cosmetic Act 1945, Rules, Schedule -Y 

5. List of Pharmacopeial Tests Quality Control Tests or Batch Testing Parameters (In-vivo)

6. List of Seven Central Drug Testing Laboratories under CDSCO in India

7. List of Items or Substances that can be Archived in the Laboratory

8. STANDARD OPERATION PROCEDURE TO MAINTAIN ARCHIVE 

9. THE NEW DRUGS AND CLINICAL TRIALS RULES, 2019

10. Frequently Encountered Deficiencies in  Animal Testing Facilities During FDA Inspections

11. List of Documents and Guidelines Used for Medical Devices Testing

12. List of Private Drug Testing Laboratories in India

13. State-Wise Pharmaceutical Manufacturing Units in India (Archived-2007)

14. List of Medical Device Companies In India

15. State-Wise Pharmaceutical Manufacturing Units in India

16. Manufacture for Large Volume Parenterals (LVP’s) in various states of India

References:

1. Central Drugs Standard Control Organization. Drug and Clinical Trial Rules. New Delhi: Central Drugs Standard Control Organization; 2019. Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI2MQ== [Last accessed on 2013 Jan 13].

                                                                    END OF DOCUMENTS

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You may like to read these links: 

1. Check Out the Tricks and Tips with Some Trouble Points While Conducting in OECD 407 and 408

2. List of OECD Guidelines or Toxicological Studies

3. List of Guidelines Used for Medical Devices Testing 

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