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Technical training and evaluation of Quality Assurance Officers. Quality Assurance

  • 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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