sop for Control of issuance of record of analysis green sheets
1.0 OBJECTIVE
To lay down a procedure for control of Record of analysis (Green sheet)
2.0 RESPONSIBILITY
Quality Control Officer
3.0 ACCOUNTABILITY
Quality Control Manager.
4.0 PROCEDURE
All green sheets used for record of analysis shall be pre numbered.
4.2 The numbers of green sheets shall have six characters, all numeric. Out of six characters, the first two characters shall
denote identification number for the green sheet for which it will be used (Dosage form/ raw material/ packaging material etc.) (Annexure-1)
4.3 The remaining four characters shall be continuous number, starting from 0001. A typical example of unique number shall be as follows,
|
0
|
1 |
0 |
0 |
0 |
1 |
4.4 A record regarding issuance of green sheet shall be made in the respective register against the
Product name / raw material / Packing name and batch no. / AR.no. For the samples received.
4.5 All green sheets shall be in bound book form (100 sheets in each book) having a counter part bearing the same unique number of the green sheet.
4.6 The counter part of the green sheet alongwith the details duly filled in, shall be retained as such in the book. These books
having counter part shall be retained for a period of 5 years.
4.7 Additional green sheet(s) can be issued to an Analyst after specifying the reason for requirement in the form as per annexure-2 and
authorization by Quality Control Manager.
4.8 The original void green sheet if any shall be filed alongwith record of analysis with duly authorized form (annexure-2).
4.9 In case of revision number in the number of green sheet, the continuous number shall start from 0001 once again. All prenumbered
old green sheets shall be destroyed and record for the same shall be maintained.
5.0 ABBREVIATIONS
Nil
5.0 ANNEXURES
ANNEXURE –I Identification number of green sheets.
ANNEXURE – II Request for additional record of analysis (Green sheets)
ANNEXURE-1
Green sheet name Identification No.
Finished product analysis 01
Raw material analysis 02
Packing material sheet 03
Continuation sheet 04
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
Entry and Exit in Quality Control Department