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 Officer/Executive QA shall retain the master documents permanently i.e. till that document is obsolete/discontinued/revised as below: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 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
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 operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
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