- OBJECTIVE :
- To lay down the procedure for training and evaluation of QA Officers on SOPs and cGMP.
- RESPONSIBILITY :
- Personnel who are knowledgeable with the subject by virtue of their qualification and experience.
- Head -Quality Assurance to ensure compliance.
- PROCEDURE :
- All Quality Assurance Officers shall undergo training and qualify on relevant/appropriate Standard Operating Procedures and Standard Cleaning Procedures as mentioned in annexure-1 and annexure-2 respectively.
- Every Quality Assurance Officer shall undergo full-fledged training on the current Good Manufacturing Practices for finished pharmaceuticals, Part 211 stated under Code of Federal Regulations relevant to their area of work.
- Quality Assurance Officers shall be imparted training on auditing procedures in individual departments.
- Lectures on subjects shall be conducted by qualified in-house/external staff.
- The subject of training shall be summarized as an abstract in the Training Log Book and duly signed by all the trainees for attendance.
- Trainees shall also fill their individual training cards.
- Evaluation of training shall be done by conducting oral / written tests, demonstrations and presentations.
- Any general/technical training on-campus or off-campus shall be entered in the individual training cards.
- For general development and training of staff, additional syllabus is outlined in the SOP “Staff Training Programme” by training department.
- Forms and Records (Annexures)
- List of Standard Operating Procedures – Annexure 1.
- List of Standard Test Procedures – Raw Materials – Annexure 2.
- List of Critical Tests – Annexure 3.
- List of Critical Tests – Annexure 4.
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision – 00 New SOP
Annexure-1.
List of Standard Operating Procedures
- Title
- Numbering system of Analytical Report Number.
- Sampling of Raw material (non-sterile)
- Approval of Raw Materials
- Handling of Reference Standards and Standardization of working standards.
- Operation and calibration of Programmable Tablet Dissolution tester, Model TDT – 06P.
- Operation and Calibration of Tablet Disintegration Tester, Model ED-2.
- Operation and Calibration of Automated Friabilator, Model EF-2.
- Operation and Calibration of Elico pH meter, Model LI-127.
- Operation and calibration of Conductivity Meter, Model CM -180.
- Operation and Calibration of Stability Oven.
- Operation and Calibration of Hot air oven.
- Operation and Calibration of LOD Oven.
- Operation and Calibration of Vacuum Oven.
- Operation and Calibration of Cold Chamber/BOD Incubator.
- Programming, Operation & Calibration of temperature Datalogger,Model Temprint 6000P.
- Operation and performance verification of muffle furnace.
- Operation and Calibration of Water Bath.
- Operation and Calibration of Bulk Density Apparatus.
- Operation and Calibration of HPLC Quaternary system with
- Variable Wavelength Detector, Model HP 1050 Series.
- Operation and calibration of Rudolph Research Polarimeter, Model Autopol IV.
- Operation and Calibration of Dissolution QA station, Make Vankel.
- Operation and Calibration of Electronic Analytical Balance, Model AG 245.
- Allotment of Lot numbers to volumetric solutions, buffer solutions, test solutions and HPLC mobile phases.
- Operation and Calibration of Melting point apparatus, Model FP 90.
- Operation and Calibration of Isocratic system, Model HP 1050.
- Operation and calibration of moisture analyser, Model LJ 16.
- Operation and calibration of K.F.Autotitrator.
- Operation and calibration of autotitrator, Model DL 25.
- Operation and Calibration of UV-VIS Spectrophotometer, Model Cary 1E/3E.
- Operation and Calibration of FT-IR Spectrophotometer, Model Paragon 1000.
- Operation of Millipore Water Purification system, Model Milli Q plus.
- Allotment of identification number to volumetric glassware and calibration of volumetric flasks, burettes, bulb pipettes, graduated pipettes and measuring cylinders.
- Operation and calibration of Electronic analytical balance, Model AG 204.
- Operation of compact clinical centrifuge.
- Operation of rotary shaker.
- Operation of Abbe Refractometer.
- Operation and calibration of Mechanical Sieve Shaker, Make: Jayanth.
- Operation and calibration of HPLC Quaternary system with diode array detector, Model HP 1050.
- Operation of Binocular Microscope.
- Operation and calibration Brookfield Viscometer, Model LVDV II+ Operation of hot plate.
- Procedure for controlling the stock of laboratory chemicals, glassware
- HPLC columns, GC columns, Spare parts and other laboratory consumables.
- Operation and Calibration of Gas Chromatograph, Model HP 5890 series
- II Plus with Headspace sampler, Model HP 7694.
- Issue and Control of registers and files.
- Operation and Performance verification of Laminar Flow Workstation, make : Clas.
- Operation and Performance verification of Horizontal Steam Sterilizer, Make : Lance Engineering.
- Maintenance of microbial cultures.
- Procurement, Preparation, Storage and disposal of microbiological media
- Operation and calibration of Anamed Electronic Balance, Model Z-4000.
- Cleaning of microbiological testing area.
- Operation of Libra balance – 1 Kg
- Monitoring of Microbial Load in Pilot Production.
- Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules.
- Procedure for cleaning of paddles/basket shafts, basket vessels, lids, bath and
- sampling lines.
- Cleaning and handling of UV-VIS Spectrophometer cells.
- Training and evaluation of Quality Control Chemists.
- Monitoring of oil content of compressed air.
- Monitoring of moisture content of compressed air.
Annexure – 2
List of Standard Test Procedures – Raw Materials
- Raw Material Name
- Sodium Lauryl Sulfate
- Croscarmellose sodium Starch
- Sodium Starch Glycolate
- Pregelatinized Starch
- Powder Cellulose
- Microcrystalline Cellulose
- Hydroxy propyl cellulose
- Titanium Dioxide
- Colloidal silicon dioxide
- Hydrogenated Vegetable oil, Type -I
- Hydrogenated Vegetable oil, Type -II
- Stearic acid
- Talc
- Opadry
- Lactose monohydrate
- Lactose anhydrous
- Dibasic calcium phosphate
- Povidone
- Magnesium stearate
- Purified water
- Potable Water
- Hydroxypropyl Methylcellulose
- Soft water
- Ibuprofen
Annexure – 3
List of Critical Tests
- Arsenic
- Bulk Density
- Hygroscopicity
- Powder fineness by Microscopy
- Distilling range
- Colour
- Heavy Metals
- Odour
- Iron
- Limit test for Salmonella species and Escherichia coli
- Limit test for Staphylococcus Aureus and Pseudomonas Aeruginosa
- Limit test for Total Aerobic Microbial Count
- Total combined Mold and yeasts count
- Dissolution
- Preparation and Standardization of Colorimetric solutions
- Residue on Ignition
- Lead
- Organic Volatile Impurities
- Dissolution apparatus – Suitability test by using Prednisone tablets RS (Dissolution Calibrator – Disintegrating)
- Dissolution apparatus – Suitability test by using Salicylic acid tablets RS (Dissolution Calibrator – Non Disintegrating)
- Differential scanning Calorimetry
- Preparation and Standardization of 0.1N Ammonium thiocynate VS.
- Preparation and Standardization of 0.1N Bromine VS.
- Preparation and Standardization of 0.05N Ceric ammonium Nitrate VS.
- Powder fineness by Sieve analysis.
- Preparation and Standardization of 0.1N cupric nitrate VS.
- Flow Properties.
- Preparation and Standardization of 0.05M Edetate disodium VS.
- Preparation and Standardization of 0.1N Ferric ammonium sulfate VS.
- Preparation and Standardization of 0.1N ferrous ammonium sulfate VS.
- Preparation and Standardization of 1N Hydrochloric acid VS.
- Preparation and Standardization of 0.5N Hydrochloric acid in methanol VS
- Preparation and Standardization of 0.1M Mercuric nitrate VS.
- Preparation and Standardization of 0.1N oxalic acid VS.
- Preparation and Standardization of 0.1N perchloric acid VS.
- Preparation and Standardization of 0.1N perchloric acid in Dioxane VS.
- Preparation and Standardization of 0.1N Potassium Bromate VS.
- Preparation and Standardization of 0.1N Potassium Bromide – Bromate VS.
- Preparation and Standardization of 0.05M potassium ferricyanide VS.
- Preparation and Standardization of 1N Potassium hydroxide VS.
- Preparation and Standardization of 0.5N potassium hydroxide, alcoholic VS.
- Preparation and Standardization of 0.1N Potassium hydroxide methanolic VS.
- Preparation and Standardization of 0.1N potassium permanganate VS.
- Preparation and Standardization of 0.1N Silver nitrate VS.
- Preparation and Standardization of 1N sodium hydroxide VS.
- Preparation and Standardization of 0.5N sodium methoxide in methanol VS.
- Preparation and Standardization of 0.1M sodium nitrite VS.
- Preparation and Standardization of 0.1N Potassium dichromate VS.
- Preparation and Standardization of 0.1N Sodium thiosulfate VS.
- Preparation and Standardization of 0.5N sulfuric acid in alcohol VS.
- Preparation and Standardization of 1N sulfuric acid VS.
- Preparation and Standardization of 0.1M tetramethyl ammonium bromide VS.
- Preparation and Standardization of 0.1M tetramethyl ammonium chloride VS.
- Preparation and Standardization of 0.1N titanium trichloride VS.
- Preparation and Standardization of 0.05M Zinc sulfate VS.
Annexure – 4
List of Critical Tests
- Assay by HPLC
- Related compounds by HPLC
- Assay by UV-VIS Spectrophotometer
- Assay by Gas Chromatograph
- Organic Volatile impurities by GC
- Chromatographic Purity by HPLC
- Dissolution
- Determination of Viscosity.
- Related Compounds by TLC.
- Water Determination K.F
- Specific rotation
- Potentiometric titrations
- Assay by perchloric acid titrations.
- Disintegration
- Bulk Density
- Arsenic
- Lead
- Heavy Metals
- Iron
- Loss on Ignition
- Loss on Drying
- Loss on Drying under vacuum
- Microbial limit tests
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