List of Items or Substances that can be Archived in Laboratory

 I. List of items that can be Archived :

1.       Project files

2.       Last unrevised SOPs 

3.       Study reports

4.       Protocol & Raw Data (of Sample tested)

5.       Scientist-assigned notebooks (Labnote Books or LNBs)

6.       Internal Audit, management review meeting, scientific meetings reports (NABL, GLP, etc )

7.       Regulatory meetings records (CPCSEA)

8.       Lab record registers (Entry-exit, weighing, Animals records, instrument log records & file)

9.       Archive disposal procedures for substances (Products) & records (documents)

10.   Previous year calibration certi

11.   Testing material is archived for 2 years or up to the expiry date (Products only) & research raw data and notebooks are maintained for 9 years or up to their expiry date (Products only).

12.  All electronic data shall be by use of a hard disk quarterly.  Records backup and retrieval: Records stored only on electronic media are supported by hardware and software necessary for retrieval. Records sorted or generated by computers have hard copies or secure backup copies. Access to archived information is documented with an access log. Records are protected against fire, theft, loss, or deterioration and are retained for a specified period if required by the regulatory authority.

13. SOP for documents, substance, and electronic data (Test substance, specimen) disposal.

14. Histopathology Laboratory Items:

a.       Organ tab (Search retention time & disposal time)

b.       Slides (Search retention time & disposal time)

c.       Blocks (Search retention time & disposal time)

c.       Tested samples  (Search retention time & disposal time)

II.  Minimum Requirements for Archive Area.

1. Specimen storage cupboards

2. Documents stored in cupboards

3. Freezer (To maintain perishable  test substances)

4. Desktop & hard disk

5. Weighing Balance with the printer (To measure the weight of the test sample)

6. Exhaust (or provision to remove harmful gases from the archive area while keeping tissue organs in formalin)

                                                                     END OF DOCUMENTS

You may like to read these links: 

1. List of All SOPs and Documents for Good Laboratory Practice (GLP)

2. List of All SOPs and Documents for In-vitro Laboratory

3. List of All SOPs and Documents for the Animal House Facility

4. List of All SOPs and Documents for Clinical Research

5. List of All SOPs and Documents for the Chemistry Laboratory

6. List of All SOPs and Documents for Quality Control

7. List of All SOPs and Documents For the Quality Assurance Dept.

8. List of SOPs and Documents Required to Achieve NABL Accreditation 

9. List of All SOPs and Documents for Laboratory Instruments and Equipment 

10. List of All SOPs and Documents for the Microbiology Laboratory

11. STANDARD OPERATION PROCEDURE TO MAINTAIN ARCHIVE 

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