Retention and disposal of documents and records

 

Retention and disposal of documents and records

 

OBJECTIVE :

1.1 To lay down a procedure for retention of obsolete/discontinued documents and                   filled records and disposal after retention period.

2.0. SCOPE :

2.1 This procedure is applicable to obsolete/discontinued documents as well as filled records being generated at abc company mentioned in procedure part.
All validation and qualification protocols and reports are governed by Validation Master Plan (VMP) and hence are excluded from the scope of this SOP.

3.0. RESPONSIBILITY :

3.1 Officer/Executive of concern department shall be responsible to provide filled records to documentation cell of QA department on monthly basis.
3.2 Officer/Executive QA shall be responsible to retain and dispose the obsolete/discontinued documents as well as filled records as per completion of retention period.

4.0. ACCOUNTABILITY: Head QA.

5.0. PROCEDURE :
5.1. RETENTION OF MASTER DOCUMENTS.
5.1.1. Officer/Executive QA shall retain the master documents permanently i.e. till that document is obsolete/discontinued/revised as below:
• Master copy of MFR, BMR, BPR: Dosage form wise file.
• Specifications and Method of analysis of Raw Material, Packing Material and Finished product:
• Standard Test Procedure (STP) .
• Worksheets of raw material, packing material and finished product testing.
• Shade cards.
• Vendor approval certificate and Approved Vendor List.
• Filled data recording annexes (formats) and filled BMR, BPR.
• Site Master File
• Standard operating procedures (SOPs)



5.2. RETENTION OF OBSOLETE / DISCONTINUED MASTER DOCUMENTS
5.2.1. Whenever any master document become obsolete / discontinued, Officer/Executive QA make the obsolete with obsolete stamp and retain.
5.3. RETENTION OF RECORDS
5.3.1. Records are the filled logbooks and annexes which is issued by QA department and filled by respective department.
5.3.2. Officer/Executive of concern departments shall forward the filled records to Officer/Executive QA for retention purpose.
5.3.3. Officer/Executive QA shall verify the received records the filled annexes as mentioned above. He/She shall file these annexes .
5.3.4. The controlled executed documents shall be retained in documentation section of QA department for the period of 3 years.
5.3.5. Filled BMR and BPR shall be retained up to one year after expiry.
5.3.6. Officer/Executive QA shall keep these records in Month-wise as well as department-wise.
5.3.7. Validation batches, BMR& BPR shall be kept as per validation documents.
5.3.8. Validation & qualification documents should not be destroyed
5.3.9. Record shall be protected from fire, pest, water, termites.
5.4. NUMBERING AND LABELLING OF FILE/BOX
5.4.1. Officer/executive QA shall affix label on each file/corrugated box having following information:
• File/box name (name of document stored wherein)
• Box No.
• Name of department (if is applicable)
• Name of dosage form (if is applicable)
• Month/Year (whichever is applicable)
5.5. DISPOSAL OF OBSOLETE/DISCONTINUED RECORDS
5.5.1. Every three months, officer/executive QA shall segregate and keep aside the documents/records to be disposed and from Annex-I. He/She shall labeled the segregated documents/records as ‘Documents for Disposal’. QA officer/executive shall disposed off the “documents for disposal” after approval from QA head.
5.5.2. Officer/Executive QA shall fill the details for documents to be disposed in Annex-I wherein documents/records mentioned which are to be disposed. Then he/she shall forward this Annex to QA Head for approval. QA Head shall review and if found satisfactory with respect to retention period, approve them by signing on each page.
5.5.3. After approval of QA Head, Officer/Executive QA shall arrange the disposition of documents through shredding or putting fire in his/her presence.



6.0 ABBREVIATION :

Sr. No. Abbreviation used Full form of abbreviation used
1.0 SOP Standard Operating Procedure
2.0 BMR Batch Manufacturing Records
3.0 BPR Batch Packing Records
4.0 STP Standard Test Procedure
8.0 QA Quality Assurance department
9.0 VMP Validation Master Plan

ATTACHMENTS (ANNEXES)         :

Annex-I           : Documents Disposition form

 

8.0.      REFERENCE

Sr. No. Reference Title
1.0 Quality assurance of Pharmaceuticals, A compendium of guidelines and related materials, Volume 2

Annex-I

Documents Disposition form

Document title Type of document

 

Document No./ Reference Prepared by QA Officer/ Executive

 

       
Authorized by QA head                                                                               

                       Sign/date:

  Date of disposition

 

Verified by QA

 

   

Remarks: The disposition of above documents shall be done only after approval of                            head QA

performance qualification protocol for water for injection

Online Rejection in parenteral

Receipt of Batch from Production to Packing Department

sop for for Spillage Handling in parenteral area

sop for calibration of vessels with dipstick

sop for Cleaning of Bins and Containers

cip of mixing vessel and holding vessel

SOP FOR BATCH MANUFACTURING

sop for placebo batch

sop for Cleaning of Ampoule Filling and Sealing Machine

sop for Fogging in Sterile and Non Sterile Area

sop for for Filtration of Bulk Solution

sop for fumigation in production area

sop for post cleaning after media fill

sop for cip of mixing vessel mixing mobile vessel and holding vessel

sop for De-Bagging of Three Piece Vial Dropper Caps

sop for calibration and verification of check weigher

sop for Batch number and Manufacturing and Expiry Date Coding System

sop for Sanitization of Seals

standard operating procedure machine history file

sop for operation and cleaning of Hand coder

sop for Cleaning and Handling and Silicone Tubes

sop on operation and cleaning of coating pan

sop for Operation of cleaning of pipe lines

Sop for equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

sop for monitoring of reprocessing of products

sop for in-process control on liquids orals

sop for in process controls on tablets capsules packaging line

sop for Issuance retrieval and destruction of BMR and analytical records

sop for in process controls during granulation compression coating inspection

sop for Cleaning of Blister packing machine

sop for for charge hand over between the shifts

Performance requalification report of visual inspectors

sop for Cleaning and operation of ROPP caps inspection table

sop for usage and destruction of filter pad and cartridge filter

sop for cleaning and storage of transfer pipe

sop for Cleaning and operation of labeling machine

Cleaning and operation of the mono block filling and sealing machine

sop for Cleaning and operation of empty bottle inspection table

sop for Cleaning and operation of filter press

sop for cleaning and operation of liquid transfer pump and line

sop for cleaning and operation of storage vessels

sop for cleaning and operation of sugar syrup manufacturing vessel

sop for cleaning issuance and retrieval of accessories and change parts

sop for Cleaning and operation of visual inspection conveyor belt

sop for Cleaning and operation of spray gun and assemble

sop for Fogging in Aseptic and Non Aseptic Area

Retention and disposal of documents and records

 

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