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sop for sampling of sterile raw material

 

sop for sampling of sterile raw material

 

1.0 OBJECTIVE 
To lay down a procedure for aseptic sampling of sterile Raw Material so as to get a
Representative sample of the whole lot for analysis.

2.0 RESPONSIBILITY

Quality Control Officer.

3.0 ACCOUNTABILITY

Quality Control Manager.



4.0 PROCEDURE

4.1 Generate Sampler’s checklist-RM as per the Batch Number mentioned in the Under Test list and decide the number of containers to be sampled as per sampling plan (Annexure – I).

4.2 Check and reconcile number of containers and the total quantity as shown in Under Test
Label. Compare the details like manufacturing date, expiry date and pharmacopoeia status mentioned on Sampler’s checklist-RM with that mentioned on manufacturer’s label. Ensure that each container is affixed with ‘UNDER TEST’ label. In case of any discrepancies inform to Quality Control Manager / Ware-House Manager.

4.1 Check the packing condition of the containers for any damages. Physically damaged
Containers shall not be considered for sampling and the same shall be Rejected..

4.2 In case of material received in triple laminated bags, the sample container received alongwith
the material shall be used for microbiological and chemical testing.

4.3 In case of sterile material received in aluminium containers, follow the procedure given
below,

4.5.1 Select the containers to be sampled and inform Ware-House Officer to transfer these containers to the raw material storage area of production block.

4.5.2 Sterilize and depyrogenate all sampling accessories as mentioned

4.5.3 Prepare label for individual container sample, with details of name of the material, Batch no., and container number.
4.5.4 Total number of labels to be prepared shall be equal to the number of containers to be sampled.

4.5.5 Prepare labels (annexure-II ) for Sample for Analysis, microbiology test and control sample.

4.5.6 Transfer the containers to the buffer zone. Follow the SOP on ‘Raw material receipt, storage, and transfer to sterile area’.

4.5.7 Enter into the sterile area following gowning and degowning procedure for sterile area.

4.5.8 Transfer the container to be sampled to the Quality Control Microbiology Lab ( Sterile Area.)

4.5.9 Ensure that temperature inside the room is less than 25 deg.C. & RH is less than 40% or as specified on Manufacturer’s label.

4.5.10 Place one container under LAF. Peel off the outer tape/seal from the mouth of the container and open the lid of the container aseptically.

4.5.11 Withdraw an appropriate quantity of sample aseptically into a piece of depyrogenated aluminium foil.

4.5.12 Observe carefully the physical appearance of the material for any abnormalities like discolouration, lumps, foreign matter and physical heterogeneity.



4.5.13 If any abnormalities are observed, collect the sample in two separate vial, for separate evaluation.

4.5.14 If no abnormalities are observed, transfer the sample equally into vials and simultaneously transfer approximately 1 gm sample in

the other vial for identification test from individual container before a pooled sample is taken for analysis.

4.5.15 Plug all vials with sterilized rubber plugs.

4.5.16 Close the lid of the container tightly, wrap the mouth with adhesive tape and remove the container from LAF booth.

4.5.17 Mark the sample containers using glass marker with batch number and container number in case of individual sample and only batch number in case of pool, control sample & micro sample.

4.5.18 Mark containers / packs which are selected for sampling with marker as N/1/n, N/2/n….N/S/n

(‘N’ stands for total number of packs / containers, ‘S’ for serial number of container selected for sampling and ‘n’ for total number of containers taken for sampling).

4.5.19 Similarly sample the rest of the containers aseptically. Refer annexure-II for total quantity to be sampled.

4.5.20 Seal all the vials with aluminium tear off seals.

4.5.21 Transfer all the containers to Air lock-1.

4.5.22 Transfer all the samples & sampling aids in the Air lock-1.

4.5.23 Clean the LAF bench and room and leave the sterile area alongwith the samples.

4.5.24 Label all the collected sample vials.

4.5.25 Affix ‘SAMPLED’ labels (Annexure – III) duly signed with date of sampling on the container.

4.5.26 Record all observations in the Sampler’s checklist-RM

4.5.27 Give the samples along with the Sampler’s checklist-RM, Supplier’s COA (if available) to Quality Control Laboratory for Chemical Analysis.

4.5.28 Inform the Ware-House Officer to shift all the containers back to Stores ‘UNDER TEST STORAGE’ area after performing decontamination of external surfaces.



5.0 Preparation of sampling accessories

5.1 Vials : Follow washing, drying, sterilizing and depyrogenate procedure as followed in normal production.

5.2 Rubber Stopper: Follow washing steam sterilization and drying procedure as followed in normal production run.

5.3 Spoons : Wash the spoon dry and wrap in 3 layers of aluminium foil, depyrogenate in Dry Heat Sterilizer at 250 degree Celsius for one hour.

5.4 Aluminium Foil : Cut pieces of aluminium foil of approximately 10cm.sq.area, wrap them in triple

layer of aluminium foil and depyrogenate in Dry Heat Sterilizer at 250 degree Celsius for one hour.

5.5 After depyrogenation of sampling accessories, transfer them to production block hatch.
Remove outer layer of wrap here, from this hatch transfer the accessories to aseptic area
hatch. Remove the second layer of the wrap and transfer them to buffer zone LAF.

6.0 ABBREVIATIONS :
SOP = Standard Operating Procedure
COA = Certificate of Analysis.

5.0 REFERENCES
In house

6.0 ANNEXURES :
Attached

 

ANNEXURE – I
SAMPLING PLAN

MINIMUM NUMBER OF CONTAINERS RECOMMENDED TO BE TESTED

Number of items in the batch Minimum no. of containers to be sampled
Not more than100 containers 10% or 4 containers, whichever is greater
More than 100 but not more than 500 containers 10 containers
More than 500 containers 2% or 20 containers, whichever is least

ANNEXURE – II
QUANTITY TO BE SAMPLED

Tests Sample Quantity (Approx.)
Chemical 40g (in two vials)
Microbiology (sterility & endotoxin) 20g
Control sample 20g
Total quantity 80g

 

Annexure III

SAMPLED

 

 

SIGN/DATE

 

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sop for for Laboratory Incident

standard operating procedure temperature monitoring

sop for drying of silica gel

sop for operation of infrared moisture balance

sop for preparation of mobile phase

sop for treated RO water

sop for Preparation and Issuance of Analysis protocol standard

sop of placebo and impurity stock solutions

sop for disposal of residual sample  

sop for handling of pharmacopoeial changes

sop for procedure for operation of ultrasonic cleaner

difference between UPLC and HPLC

sop for for Emergency Eyewash and Shower

sop for operation and calibration of total organic carbon analyzers

sop for operation of cobb tester

sop for Operation and calibration of atomic absorption spectrophotometer

sop for Operation and calibration of gas liquid chromatograph

sop for operation of humidity oven

sop for operation and calibration of serological water bath

sop for monitoring of drain trap

sop for destruction of analytical samples after testing and control samples

sop for destruction of used chemicals

Sop for Operation of suction pump

sop for Operation and calibration uv cabinet

sop for Operation and calibration of bulk density apparatus

sop for operation and calibration of shore hardness tester

sop for operation of rub proofness tester

sop for monitoring of purified water

sop for Retesting of packaging materials

sop for Retesting and resampling of raw materials

sop for Control of issuance of record of analysis green sheets

sop for Control of computer passwords

sop for sampling of packaging materials PM

sop for sampling of sterile raw material

sop for sampling of intermediates and finished products

sop for operation and calibration of friability test apparatus

sop for approval and rejection of packaging materials

sop for non conformance of RM PM and finished product

sop for collection storage and disposal of control samples

sop for trend analysis of finished products

sop for Chromatographic practices and system suitability

SOP For Good Laboratory Practices

sop for cleaning and operation of sieve shaker

general specification of packing material cartons

sop for Password for Analytical Instrument and LIMS software

sop for Rounding off numerical analytical results

sop for sampling of bulk and finished product

sop for cleaning of spillage material

sop for Handling of Reference Standard

sop for hplc column maintenance and washing

procedure for sampling and handling of bulk sample

STP for borewell generation point (raw water storage tank)

sop for preparation and standardization of 0.1M Zinc Sulphate

Operation &calibration of analytical balance (dhona)

Operation and Calibration Procedure for Disintegration Test apparatus

sop for preparation and standardization of 1 M Hydrochloric Acid

Preparation and standardization of 0.1 M ceric ammonium sulphate solution

sop for preparation and standardization of 0.05 m iodine solution

validation of volumetric solution 0.1m ammonium thiocyanate

handling of reference standard and preparation of working standard

sop for water sampling and analysis

sop for operation for validation of excel worksheets

sop for laboratory cleaning

sop for stability of volumetric solutions

sop for preparation of raw material in process finish product packing material data sheets

sop for handling of hazardous chemicals

sop for handling of glassware and allocation of identification number

sop for operation cleaning and calibration of bursting strength tester

sop for rounding off the analytical test results

procedure for Analyst Qualification

sop for operation and calibration of dissolution Apparatus

procedure for maintenance of desiccators

sop for for hplc column receipt checking id no and regeneration

safety data sheet for laboratory chemicals

procedure for handling of poisonous chemicals

sop for cleaning of sampling devices

sop for calibration procedure of instruments

sop for specification and standard testing raw material packing material and finished product

procedure for operation and calibration of potentiometric titrator

procedure for operating and calibration of digital hardness tester

procedure for disposal of expired chemicals, reagents and solvents

sop for behavior in quality control department

sop for preparation and standardization 0.1M sodium thiosulphate

sop for preparation and standardization 0.1M Disodium Edetate

preparation and standardization 0.1M Sodium Hydroxide Solution

Preparation and standardization of 0.1M Perchloric acid solution

sop for preparation 0.05M edetate disodium

sop for preparation 0.1M silver nitrate

sop for Operation and Calibration of High Performance Liquid Chromatography

sop for UV & Visible Spectrophotometer

procedure for Cleaning of laboratory glassware

Cleaning of Instrument, Instrument bench and surrounding area of Quality

Safety Precaution in Quality Control Department

Operation & Calibration of Analytical Balance

Calibration of Glassware in Quality Control Department

handling of samples received in Quality Control

Cleaning and Operation of Refrigerator

Operation, Cleaning and Calibration of water bath

Operation & Calibration of Refractometer

Operation and Cleaning of Centrifuge Apparatus

cleaning, operation & calibration of Vernier caliper

Calibration of Fourier Transform Infrared Spectrophotometer (FTIR)

Cleaning and operation of Moisture Analyzer

Cleaning & Operation of Vacuum pump in Quality Control Department

Operation and Calibration of Polarimeter

Cleaning and operation of Magnetic Stirrer

Cleaning Operation and Calibration of Melting Point

Operation Cleaning and Calibration of Muffle Furnance in Quality Control Department

procedure of operation and Cleaning of Sonicator

Operation Cleaning & Calibration of pH meter in Quality Control Department

Entry and Exit in Quality Control Department

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