sop for sampling of packaging materials PM
1.0 OBJECTIVE:
To lay down a procedure for sampling of packing materials so as to get the representative sample of the whole lot.
2.0 RESPONSIBILITY
2.1 The Officer / Assistant – Quality Control Packaging
2.2 The Executive – Quality Assurance
3.0 ACCOUNTABILITY
Executive – Quality Assurance
4.0 PROCEDURE:
4.1 Receive Goods Receipt Note (GRN) from Warehouse and record relevant information’s in packaging material register.
4.2 Take out Photocopy of Sampler’s Check List – PM
4.3 The separate sampler’s remark shall be used for each lot of Batches.
4.4 Prepare the “UNDER TEST” label from the computer system to affix on the consignment.
4.5 Check the delivered items to ensure that the quantity received corresponds with the GRN Quantity
4.6 Fill the necessary details in Sampler’s Check List by taking the reference of Goods Receipt Note (GRN). If discrepancy found in GRN inform to warehouse for corrective action.
4.7 Go to the Quarantine area and identify the material to be sampled from Quarantined label which is affixed by Warehouse on the packs.
4.8 In case of Aluminium and PVC foils carry out the sampling under Laminar Air Flow (LAF).
4.9 Cleaning of LAF shall be carried out on every alternate day or early if required. The LAF shall be cleaned with wet mop followed by dry mop.
4.10 The cleaning shall be recorded in the cleaning record for LAF
4.11 Ensure that the surrounding area is clean, if not get it cleans, prior to start of the sampling.
4.12 Check the packing condition of the material and details mentioned on the Under Test labels.
4.13 Verify that the Quarantine Labels are affixed by Warehouse Personnel.
4.14 In case of any discrepancies intimate to Executive / Head – Quality Assurance or Head – Quality Control for necessary action.
4.15 Ensure that packs are cleaned externally and open the packages only after ensuring the proper cleaning. Observe the material for any abnormalities and record it on the Sampler’s Check List.
4.16 Check the following points during sampling of the material: –
4.16.1 Mode of packing,
4.16.2 Indication of packing,
4.16.3 Details available on pack (Containers),
4.16.4 No. of packs (containers) received,
4.16.5 Total quantity received,
4.16.6 No. of packs (containers) sampled,
4.16.7 Quantity to be sampled.
4.16.8 Name of the person who sampled along with date of sampling.
4.17 Withdraw the samples randomly by opening different containers / Boxes as per ROOT N +1 and take out sampling quantity for visual inspection as per sampling plan
4.18 Note down the sampled quantity in Sampler’s checklist based on the number of packages to be sampled.
4.19 Examine the sampled material as per AQL against the approved standard for general appearance, deviation from normal visual quality, colour, text etc. wherever applicable.
4.20 Record the results in approved Visual Inspection Report for Aluminium foil and PVC Foil.
4.21 After completion of sampling the material pack shall be resealed with BOPP Tape or tied with the help of cable – tie.
4.22 Affix the “UNDER TEST” refer Annexure – 4. To all the rolls of sticker labels, foils and every container of rubber plugs.
For all other packaging materials at least one “UNDER TEST” Label shall be affixed on bottom container/ pack of each pallet.
4.23 Affix the SAMPLED BY QC sticker label duly signed and mentioning the container number according to sampling plan,
on outer container of the material from which sample is taken.
4.24 Check that the number of packs is correct as mentioned in under test label.
4.25 Take out composite sample for analysis as per respective Packing Material Specifications. Put the sampled quantity
in self-sealing polybag bearing the label of “SAMPLE FOR ANALYSIS”
4.26 Carry out testing of the packaging material as per the laid down specifications of respective material.
4.27 The sampling procedure described above will not be applicable for Tertiary Packaging material like Shipper,
pad, partition and corrugated trays. For these materials only one unit shall be collected and carry out the analysis as per laid down specification.
5.0 REASON FOR REVISION:
SOP is revised to incorporate detailed sampling procedure as per AQL and incorporation of Packaging material inward register.
6.0 TRAINING:
Trainer — Executive – QA
7.0 DISTRIBUTION:
Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : File Copy for Packaging Department
Certified Copy No. 3 : Head – PLANT OPERATIONS
Original Copy : Head – QUALITY ASSURANCE
8.0 ANNEXURES:
Annexure – 1 : Format for Packaging Material Register
9.0 REFERENCE:
In-house.
sop for Calibration and Maintenance of Laboratory Instruments and Equipment
Disposal of Residual Sample or Left Over Material
sop for for Laboratory Incident
standard operating procedure temperature monitoring
sop for operation of infrared moisture balance
sop for preparation of mobile phase
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 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