Storage, Retrieval & destruction of control Samples
This Document describes (Standard Operating procedure) SOP for storage, Retrieval & destruction of control Samples
SOP for storage, Retrieval & destruction of control Samples
I. Purpose & Scope:
- The purpose of this SOP for storage, Retrieval & destruction of control Samples
- This Standard operating procedure shall be applicable for storage, Retrieval & destruction of control Samples
II. Responsibilities:
• All Quality Assurance personnel shall be responsible to follow and implement this SOP.
III : Introduction and Procedural Part :
Procedure :
- Sampling of Finished products shall be planned so as to collect representative sample of the batch being processed in Packaging section of Tablet, Capsule, Ointment & Injection.
- The sampling shall be done throughout the process of packing at different interval (Initial, middle and near end of operation)
- Control sample shall be drawn in its original packs after filling in case of Ointments.
Collection and Storage of Control Samples of Finished products :
- Control samples shall be collected for each batch / pack and sticker of control sample should be affixed on the unit pack of Tablet/ Capsule/ Ointment as per status labeling Annexure.
- During the Packing operation, IPQA officer collect a representative sample of packed goods and record in the Control sample register.
- Quality Assurance Officer is responsible for maintenance of Control samples and shall record the details in Control sample register
- The Control samples shall be stored in the specified area at below 25°C temperature. Record the temperature twice in a day
- Control samples shall be maintained as Rack wise and record the entry of location chart of control sample room
- Finished product Control samples shall be maintained for a period of one year after the expiry date mentioned on product pack.
- Quality Assurance Officer is responsible for maintenance of Control samples tracking system.
COLLECTION & STORAGE OF CONTROL SAMPLES OF RAW MATERIALS:
- QC officer is responsible for Sampling of raw materials and sample the raw materials as per SOP.
- Quality Assurance Officer shall responsible for maintenance of control samples of Raw Material. The control samples shall be stored in control sample room at temperature below 25°C.
- QC Officer maintains the control sample of raw material twice the quantity of analytical sample.
- Keep the samples in HDPE container with proper labeling and record maintain in the control sample of raw material register.
- Arrange the raw material control samples serially in the HDPE with proper labeling.
- Raw material control samples shall be retained for a period of one year after the date of expiry (Expiry+ one year )
COLLECTION & STORAGE OF CONTROL SAMPLES OF PACKAGING MATERIALS:
- QC officer is responsible for sampling of packaging materials and sample the packaging materials as per SOP.
- Quality control Officer shall keep one specimen sample of packaging Material as the attached retained sample to respective analytical report of packaging material (Carton, insert /leaflet, Aluminum seal, label /sticker labels etc.). For other packaging material (Plain foil, printed foil, PVC/PVDC etc.) kept the cut piece of the respective packaging material.
- Quality control officer shall mention the analytical report number with sign and date on respective retained specimen sample for traceability of unique identification number.
- Retained specimen sample shall be retained along with respective analytical report in the QA documentation cell for a period of one year after the date of expiry.
WITHDRAWAL OF CONTROL SAMPLE :
- Prior permission shall be taken from Quality Assurance Manager for withdrawal of any control sample on requisition slip.
- Control sample shall be withdrawal for the following purpose:
- For market complaint investigation.
- For product study.
- For regulatory requirement/ Statutory requirement.
- On request of marketing agency.
- For physical verification
- Control sample should be withdrawn based on the availability of control sample.
- Destruction of finished product control samples to be done if integrity impact on primary packing material.
REVIEW OF FINISHED PRODUCTS CONTROL SAMPLE :
- Control samples shall be reviewed by visual examination at least once in a year as per given individual Formats:
- 1 blister of tablet /1 strip of capsule /1 tube of ointment / 1vial of injection shall be used for visual inspection.
- The sample used for visual inspection shall be discarded after visual inspection if failure of integrity.
- Any evidence of control samples deterioration shall be intimated to Quality Head or his/her designee and shall be investigated
DISPOSAL :
- Control samples shall be destroyed as per Destruction procedure described in SOP.
- The record of destruction shall be signed by concerned person.
PROCEDURE FOR DESTRUCTION :
TABLET & CAPSULE:
- All strips/blister should be cut open. Remove all tablets/ Capsule from the strips
- Collect all the tablets/capsule put in a bucketful of water and leave for one hour.
- Ensure no intact tablets/capsule remains in water and drain the water in to ETP.
- Destroy the strips (without tablets/capsule) and empty cartons, Leaflets, Labels and shippers by tearing off into pieces so that they cannot be reused.
OINTMENTS/CREAMS/GELS:
- Squeeze out the contents in a bucket and drain it into ETP.
- Cut empty squeezed tubes into two or more pieces.
- Tear off the cartons, Labels, Leaflets & shippers into pieces.
- All such tubes and cartons should be destroyed in such a way that they cannot be reused.
- Squeeze out the contents in a bucket and drain it into ETP.
- Cut empty squeezed tubes into two or more pieces.
- Tear off the cartons, Labels, Leaflets & shippers into pieces.
- All such tubes and cartons should be destroyed in such a way that they cannot be reused.
- In case of lotion, pour out the content in bucket and drain it into ETP. In case of containers, burn/puncture the containers
INJECTION :
- All vials should be cut open.
- Remove all the powder from vials.
- Collect the powder in a bucketful of water and leave for one hour.
- Ensure no intact powder remains in water and drain it in to ETP.
- Destroy the vials (without powder) and empty cartons, Leaflets, Labels and shippers by tearing off into pieces so that they cannot be reused.
RAW MATERIALS:
- Raw Materials shall be removed from their container.
- The containers shall be destroyed by breaking (in case of glass) or by cutting (in case of plastic).
- Collected materials put in a bucket of water & leave for one hour & drain it in ETP.
RECORD OF DESTRUCTION :
- Control samples shall be destroyed as per Destruction procedure described in SOP
- The record of destruction shall be signed by concerned person.
ANNEXURE :
| Annexure No | Format Name |
| Annexure – I | Control sample issue slip |
| Annexure – II | Control sample temperature record |
| Annexure – III | Visual Observation Of Control Sample (Tablet) |
| Annexure – IV | Control sample raw material resister |
| Annexure – V | Control sample finished product resister |
| Annexure – VI | Control sample location chart |
| Annexure – VII | Visual Observation of Control Sample (Tablet) |
| Annexure VIII | Visual Observation of Control Sample (Capsule) |
| Annexure IX | Visual Observation of Control Sample (Ointment) |
| Annexure X | Visual Observation of Control Sample (Injection) |
- Annexure I
- Control Sample Issue Slip
| Requested by Name : |
|
| Department : |
Designation Sign/date |
| Name of material/Product : | |
| A.R No./Batch No. : | |
| Quantity required : | |
| Reason/Purpose: | |
|
Approved by QA :
Instruction :
Remark :
|
|
| Quantity issued : |
|
| Remaining quantity : | |
| Control sample needed updated : Yes /No : | |
|
Received by sign/date Verified by sign/date
|
|
- Annexure II
CONTROL SAMPLE TEMPERATURE RECORD
Limit: Temp.: Not More than 250C Page 1 of 1
| Date | Time | Temp. in 0C | Min
Tem 0 C |
Max
Tem 0 C |
Checked By | Date | Time | Temp. in 0C | Min
Tem 0 C |
Max
Tem 0 C |
Checked By |
Reviewed By : _______________________
Department Head
Annexure III
VISUAL INSPECTION OF CONTROL SAMPLE
| VISUAL INSPECTION OF CONTROL SAMPLE FOR TABLETS, CAPULE, OINTMENT & INJECTION | ||||||||||||||||||
| PRODUCT NAME: |
|
QTY: | MARKET: | RACK NO: | SIGN & DATE | DESTROYED BY |
REMARKS | |||||||||||
| B. NO. | MFG DATE |
EXP. DATE |
PACK SIZE |
YEAR | Defects* | |||||||||||||
| Appearance | Sticking/Picking/ Capping/chipping/ Black Spot | Foreign Particles /Broken/Powered/ Crushed/pinholes | Mottling/Peeling/Rough Surface/logo defects/Twin | Others | ||||||||||||||
| Initial | ||||||||||||||||||
| 1ST | ||||||||||||||||||
| 2ND | ||||||||||||||||||
| 3RD | ||||||||||||||||||
| 4TH | ||||||||||||||||||
| Initial | ||||||||||||||||||
| 1ST | ||||||||||||||||||
| 2ND | ||||||||||||||||||
| 3RD | ||||||||||||||||||
| 4TH | ||||||||||||||||||
| Initial | ||||||||||||||||||
| 1ST | ||||||||||||||||||
| 2ND | ||||||||||||||||||
| 3RD | ||||||||||||||||||
| 4TH | ||||||||||||||||||
Annexure IV
Control Sample Register for Raw material
| Date | Name of material | A.R. No. | MFG Date | EXP Date | Quantity | Box No | Qty. Requested by | Reason for withdrawn | Qty.Withdrwn by | Balance Quantity | Sign | Due for Destruction | Destroyed by | Checked by |
Reviewed By : _______________________
Department Head
Annexure V
Control Sample Register for Finished Product
| Date | Name of Product | Batch No | Mfg. date | Exp.date | Quantity | Box No | Qty. Requested by | Reason for withdrawn | Qty.Withdrwn by | Balance Quantity | Sign | Due for Destruction | Destroyed by | Checked by |
Annexure VI
LOCATION CHART OF CONTROL SAMPLE FOR TABLET, CAPSULE, OINTMENT & INJECTION
| Shipper / Box No.: | Location: | ||||
| Sr.No. | Product Name | Batch no. / A.R.No. | Mfg. Date | Exp. Date | Remark |
Annexure VII
VISUAL OBSERVATION OF CONTROL SAMPLE (TABLET)
Product Brand/Generic Name: _________________________________________________________ Batch No.:___________________
MFG Date: _______________________ Expiry Date: _______________________________________
| Observation Year | Defects | Sign & date | Destroyed by |
Remarks | |||||
| Appearance
(Ok/Not ok) |
Sticking/Picking/ Capping/Chipping
(Observed /Not observed) |
Foreign Particles /Broken tablet /black Spot (Observed /Not observed) | Mottling/Peeling/Rough Surface/Logo Defects (Observed /Not observed) | Printing on Carton/Blister/ Strip sealing
(Ok /Not ok) |
Others | ||||
| 1st year
________ |
|||||||||
| 2nd Year
_________ |
|||||||||
| 3rd Year
__________ |
|||||||||
| 4th Year
__________ |
|||||||||
| Other | |||||||||
Product Brand/Generic Name: _________________________________________________________ Batch No.:___________________
MFG Date: _______________________ Expiry Date: _______________________________________
Annexure VIII
VISUAL OBSERVATION OF CONTROL SAMPLE (Capsule)
Product Brand/Generic Name: _________________________________________________________ Batch No.:___________________
MFG Date: _______________________ Expiry Date: _______________________________________
| Observation Year | Defects | Sign & date | Destroyed by |
Remarks | |||||
| Appearance
( free from mashed, bent, double cap, scrape, improper print) (Ok/Not ok) |
Dented/Color Variation/
discoloration/ swelling / split capsule (Observed/ Not observed) |
Locking defect /Loose Cap/Body or Cap broken /crack Capsule /black Spot on Body or Cap (Observed/
Not observed) |
Telescopic/ Foreign Particle/Peeling/ /punched ends/ (Observed/
Not observed) |
Printing on Carton/
Blister/ Strip (Ok/ Not ok) |
Others | ||||
| 1st year
________ |
|||||||||
| 2nd Year
_________ |
|||||||||
| 3rd Year
__________ |
|||||||||
| 4th Year
__________ |
|||||||||
| Other | |||||||||
Product Brand/Generic Name: _________________________________________________________ Batch No.:___________________
MFG Date: _______________________ Expiry Date: _______________________________________
Product Brand/Generic Name: _________________________________________________________ Batch No.:___________________
MFG Date: _______________________ Expiry Date: _______________________________________
Annexure IX
VISUAL OBSERVATION OF CONTROL SAMPLE (Ointment)
| Observation Year | Defects | Sign & date | Destroyed by |
Remarks | ||||
| Appearance
(Ok/Not ok) |
Crimping /Denting/ improper sealing/
(Observed/Not Observed) |
Foreign Particles/Black Particle in product (Observed/Not Observed) | Printing/Coding/on Tube/Carton
(Observed/Not Observed) |
Others | ||||
| 1st year
________ |
||||||||
| 2nd Year
_________ |
||||||||
| 3rd Year
__________ |
||||||||
| 4th Year
__________ |
||||||||
| Other | ||||||||
Annexure X
VISUAL OBSERVATION OF CONTROL SAMPLE (Injection)
Product Brand/Generic Name: _________________________________________________________ Batch No.:___________________
MFG Date: _______________________ Expiry Date: _______________________________________
| Observation Year | Defects | Sign & date | Destroyed by |
Remarks | ||||
| Physical Appearance
(Ok/Not ok) |
Flip off sealing
(Ok/Not ok) |
Foreign Particles/Black Particle/Crack on Vial
(Observed/Not Observed) |
Printing/Coding/on Vial/Carton
(Observed/Not Observed) |
Others | ||||
| 1st year
________ |
||||||||
| 2nd Year
_________ |
||||||||
| 3rd Year
__________ |
||||||||
| 4th Year
__________ |
||||||||
| Other | ||||||||
