by 1.0 OBJECTIVE
To describe the procedure for handling of records.
2.0 SCOPE
This SOP is applicable for all the functions.
3.0 RESPONSIBILITY
- Quality Assurance (QA) personnel staff shall be responsible for:
- Handling of relevant records.
- Disposal of records after retention period.
- Head QA shall be responsible for:
- Ensuring that the procedures defined are adhered to.
4.0 ACCOUNTABILITY
Head- Quality Assurance
5.0 PROCEDURE
5.1 Collection and retention of records
5.1.1 Complete the records at the time each action is taken.
5.1.2 Hand over the entire batch manufacturing record and approved analytical data to QA.
5.1.3 Store the record after review and approval in documentation room.
5.1.4 Store all other records in individual department in a manner that the identity and details of the record can be easily traceable.
5.1.5 The controlled documents (e.g. specification, method of analysis, Master Formulation Record, Batch Manufacturing Documents) provided by contract givers or clients shall be distributed through quality assurance as a controlled copy (QA shall retain the original copy) and the previous version (original) shall be stamped with OBSOLETE stamp after retrieving it. The previously distributed copies shall be destroyed.
5.2 Retention period of records
| Type of document | Minimum retention period |
| 1.0 Equipment | |
| – Cleaning, usage and maintenance records | 5 years from the last date of entry. |
| – Calibration records | 5 years from the date of calibration |
| – Qualification records | Permanent |
| 2.0 Starting material and packaging material | |
| – Receipt and verification records | 5 years |
| – Sampling, testing and release record | 5 years from the date of release |
| – Inventory record | 5 years |
| – Labeling records | 5 years |
| – Rejection and disposition record | 5 years |
| 3.0 Batch production records | |
| – Master formula record of each product | Permanent |
| Type of document | Minimum retention period |
| – Batch manufacturing, In process control, sampling and packing records | 5 years form the date of release |
| – Batch distribution records | 5 years from the date of distribution |
| – Labeling records | 5 years |
| Art Work | 5 years |
| 4.0 Laboratory records | |
| – Testing and release record | 5 years from the date of certification |
| – Reference and working standard records | 5 years from the date of certification |
| – Volumetric solution records | 5 years |
| – Obsolete copy of specification & testing procedure | 5 years from the date of issue |
| – Environmental monitoring record | 5 years form the last date of entry |
| – Stability studies records | Permanent |
| 5.0 Qualification and validation records | |
| – Building qualification record | Permanent |
| – Facility qualification record | Permanent |
| – Water system qualification records | Permanent |
| – Process validation records | Permanent |
| – Software validation records | Permanent |
| – Method validation records | Permanent |
| – Cleaning validation record | Permanent |
| 6.0 Quality system records | |
| – Market complaint record | Permanent |
| – Product recall record | Permanent |
| – Process deviation record | Permanent |
| – Change control record | Permanent |
| – Non conformance report | Permanent |
| – Out of specification record | Permanent |
| – Failure investigation record | Permanent |
| – Annual product and quality review record | 5 years |
| – Internal quality audit report | 5 years |
| – Obsolete copy of standard operating procedure | 5 years from obsolete date |
| – Training records | 5 years |
| 7.0 General | |
| – Validation master plan | Permanent |
| – Site master file | Permanent |
| – Departmental manuals | Permanent |
| – Drug master file (DMF) and product dossier | Permanent |
| – Vendor audit report | Permanent |
| – Medical check up record | 4years |
- 5.3 Issuance of record
5.3.1 Whenever need arise to reevaluate the record, which is under custody of documentation department send a justified request to QA.
5.3.2 After verifying the reason, Executive QA will make the entry in issuance sheet with recording the issuance details.
5.3.3 Return the complete issued record back to QA after completion of required activity.
5.3.4 Verify the completeness of returned record and enter the details of returned record in the same annexure as above.
5.4 Disposal of records
5.4.1 After completion of specified retention period, prepare the list of records to be disposed, take the approval of Head of the department.
5.4.2 After getting approval, take out the record from the storage place and dispose it off by shredding /cutting it in to pieces and send it to scrap yard.
6.0 TRAINING
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
7.0 DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
8.0 ATTACHMENT
| Sr. No. | Annexure No. | Title | Format No. |
| 1 | NA | NA | NA |
9.0 REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
