OBJECTIVE:
To describe the procedure for retention of Quality & GMP related documents.
SCOPE:
The scope of this SOP is to provide harmonized procedure for retention of quality Documents at Kshitij Pharma solutions of companies.
RESPONSIBILITY:
Document Owner/ Individual
To identify and collect the documents for submission in QA.
To submit the documents to QA after completion of activity.
Quality Assurance
- To verify the documents and enter the details in the respective log book.
- To place the documents in the respective location/ rack in document archival room with proper identification.
- Approval for relocation of documents.
- Approval for destruction of documents after completion of retention period.
- To witness for shred the documents after destruction approval.
Administration/ EHS Department
Responsible for destruction/ disposal of shredded documents.
Head CQA or Designee:
Responsible for archival and proper retention of documents.
Head Quality Assurance or Designee:
Responsible for archival and proper retention of site documents.
PROCEDURE:
Definition
Document:
A piece of written, printed, or electronic matter that provides information or evidence or that serves as an official record.
Standard operating procedures (SOPs): Step-by-step instructions for performing operational tasks or activities.
Protocol: Give directions to perform the activities.
Records: Provide evidence of various actions taken to demonstrate compliance with instructions, e.g activities, events, investigations, and in case of manufactured batches a history of each batch of product including the distribution.
Batch Records: Document which provide step-by-step instructions for production related tasks and activities.
Logbooks: Collection of forms used to document activities. Logbooks are used for documenting the operation, maintenance, and calibration of a piece of equipment.
Logbooks are also used to record critical activities, e.g., monitoring of clean rooms, solution preparation, recording of deviation, change controls and its corrective action assignment.
Destruction of Documents/ Records:
It means the final stage in record management whereby documents/ records which are no longer worthwhile or needed in terms of administration, research and investigation are stored and disposal of in accordance with the define procedures.
Pre-Requisites
Document store/ retention room shall be properly maintained w.r.t. sufficient racks/ compactor, adequate cleaning, lighting, ventilation, smoke detector, fire extinguisher, adequate pest control etc.
Room should be provided with lock & key or access control facility to restrict the unauthorized entries in the area.
Authorized personnel list shall be maintained and to be displayed.
List of authorized personnel shall be prepared as per Annexure.
All documents should be arranged in proper manner with easy traceability.
Documents retained for life time shall not be destroyed.
Any visitor/employee of company can enter in the documentation room along with the authorized person of QA department only.
Retention of Documents/ Records
Generally record is generated in the form of manually written and pre printed documents.
The criteria for retention of the documents are defined in two types:
Perpetual (Permanent/lifetime)
Transitory (Defined time period)
Perpetual Documents/ Records: A document/ record which is retained permanently for life time because of its procedure, historical or legal value.
Transitory Documents/ Records: A document/ record which shall be retained as per defined specific retention period.
Secure control shall be in place to ensure the integrity of the record throughout the retention period of the documents. All documents shall be arranged in proper manner with easy traceability.
Retention period of documents/ records (Paper based hard copy & electronic copy) shall be as per Annexure
Respective user department shall submit the documents/ records to QA after completion of activity and completion of documents and done the entry in the “Document Submission & Retention Record” as per Annexure in the presence of QA.
The submitted documents/ records shall be retrieved and verified as per the details filled up by concern department in the Annexure and shall be received by QA.
After submission of documents/ records, if required note for additional information, QA shall mention the details in remark column.
QA shall mention the retention period of document/ record and destruction date as per retention time defined in Annexure and allot the rack no./ location where document shall be stored as per availability.
Respective person from QA shall place the documents/ records in the respective place with proper identification of document which can visualized and identified easily.
Excel sheet can be maintain by site QA for traceability of location of documents in document store room and it shall be handled by authorized person from QA and shall be password protected.
Rack No./Sub Rack No./Box No/File No etc. can be maintained in the excel sheet for easy traceability.
In case of any specific requirement for re-locating the documents from existing location/ compactor/ racks then before relocation, documents relocation details shall be approved by QA Head/ Designee as per Annexure and after approval, document shall be relocated in new location and details shall be filled in Annexure.
All the master / executed documents and other controlled documents like preprinted blank formats, logbooks, registers, raw data shall be stored in secured place.
All documents shall be retained for desired period of time as per Annexure.
otherwise justified and documented as per site specific procedure.
In case of any specific recommendation of Customer/Regulator/QA/CQA, documents shall be retained accordingly with proper justification as per site specific procedure.
The backup electronic data other than described in Annexure shall be stored for at least Ten years in safe condition so that they can be reproduced/ retrieved after any disaster or crisis.
Document Destruction Procedure:
The documents/ records which is due for destruction, shall be isolated and removed from document record room.
Documents destruction shall be done within 3 month from the due date of destruction. Document destruction shall be done only after shredding activity.
The list of documents which is to be shred shall be prepared as per Annexure. “Record for Document Destruction”.
List of documents for destruction shall be approved by QA Head before destruction.
After approval documents shall be shredded at designated place through shredding Machine in presence of QA.
Record of shredding shall be maintained by QA.
Shredded material shall be packed in polythene bags and sent to EHS for further Disposal.
Final disposal of shredded materials shall be done through EHS as per site specific SOP.
In case documents are required for future reference, scan copy can be retain for more time as per requirements.
Record of destruction shall be retained for at least 6 years from the date of destruction and then shall be destroyed by above procedure.
If, In case of any specific customer / regulatory requirement, records shall be retained for more than its retention period and the same shall be done after approval from the Head QA. The necessary entries shall be recorded and the label for destruction to be updated accordingly.
Documents / Records related to any legal litigation from local and regulated authority shall not be destroyed until the litigation is resolved.
Documents / Records retrieval procedure shall be followed as per defined procedure and its reconciliation and obsolete record shall be maintain.
Issuance of Submitted & Retained Documents From Document Retention Room
In case of any requirement raised by other departments except QA for documents which are retained in document storage room for reference/ review/ other purpose then request shall be raised by concerned person for issuance of document.
In the request, required details of retained document with reason for issuance shall be mentioned and this shall be reviewed by department head/ designee and submitted to QA concern person and also approved by QA head or its designee.
Request for issuance of retained document shall be prepared as per Annexure
After request approval, document shall be issued to concern person and details of document shall be filled in Retained document issuance register.
In case of any requirement of document by QA itself for more than one day then requirement shall be reviewed by concerned QA staff and same procedure shall be followed for issuance of submitted/ retained documents.
Retained document issuance record shall be prepared as per Annexure
ANNEXURE (S):
Annexure I : List of Documents/ Records with their Retention Period
Annexure II : List of Authorized Personnel
Annexure III Documents Submission Record
Annexure IV : List of Documents for Destruction
Annexure V : Document Relocation Form
Annexure VI : Request For Issuance of Retained Documents
Annexure VII : Retained Documents Issuance Record
ABBREVIATION(S):
QA : Quality Assurance
CQA : Corporate Quality Assurance
CSOP : Corporate Standard Operating Procedures
GMP : Good Manufacturing Practices
CAPA : Corrective Action & Preventive Action
OOS : Out of Specification
OOT : Out of Trend
QRA : Quality Risk Assessment
COA : Certificate of Analysis
HPLC : High Performance Liquid Chromatography
GC : Gas Chromatography
GLP : Good Laboratory Practices
PPA : Powder Processing Area
IPA : Iso Propyl Alcohol
HVAC : Heating Ventilation & Air Conditioning
HEPA : High Efficiency Particulate Air
HR : Human Resource
CCP : Change Control Proposal
SCM : Supply Chain management
I.T. : Information Technology
LIMS : Laboratory Information Management System
w.r.t. : With Respect To
EHS : Environment Health & Safety