Quality Control of Ayurvedic products .pptx

Ayurvedic Quality control

1. QUALITY CONTROL IN AYURVEDA Bijeshmon PP Manager – Quality control Sitaram Ayurveda Pvt. Ltd Thrissur

2. QC Departments and its Functions Type of Raw Materials & Testing Types of Finished Products & Testing Major Instruments and functions CONTENTS Sample flow at QC Lab

3. QC DEPARTMENT Chemistry Pharmacognosy Microbiology

4. FUNCTIONS OF QC LAB To ensure the quality of Raw materials used in medicines To check the finished product for the required parameters and Standards Stability Testing

5. QUALITY EVALUATION RAW MATERIALS & FINISHED PRODUCTS ORGANOLEPTIC BOTANICAL MICROBIAL CHEMICAL PHYSICIAL

6. ORGANOLEPTIC COLOUR ODOUR TASTE TEXTURE

7. BOTANICAL MACROSCOPIC MICROSCOPIC

8. PHYSICAL FOREIGN MATTER MOISTURE CONTENT ASH VALUES EXTRACTIVE VALUES pH VISCOSITY OPTICAL ROTATION

9. CHEMICAL PHYTOCHEMICAL CHROMATOGRAPHY HEAVY METAL PESCTICIDE

10. MICROBIAL TOTAL PLATE COUNT TOTAL YEAST & MOULD E.COLI SALMONELLA SPP. STAPH SPP. PSEUDOMONAS SPP. SWAB TEST, WATER ANALAYSIS

11. SAMPLE FLOW IN QUALITY CONTROL RECEIPT OF SAMPLE PRIMARY OBSERVATION ENTRY IN TO SRD REGISTER ASSIGN WORKS ANALYSIS AS PER MOA RESULTS TO WORK BOOK REVALIDATION OF RESULTS ENTRY IN TO REGISTERS & ERP APPROVAL/ REJECTION

12. Herbal Raw materials ( Dried and Raw) Animal by products ( Ghee, Honey, Wax etc.) Metals & Minerals (Lohabhasma, Annbhedi sindoora etc.) TYPES OF RAW MATERIALS Plant by products (Oils, Sugar, Jaggery etc.)

13. RAW MATERIALS Colour Odour Taste Texture Anatomical studies Powder microscopic studies Foreign matter Total Ash Acid-insoluble ash Alcohol-soluble extractive Water-soluble extractive Volatile oil determination Heavy Metal Analysis Total Aerobic bacteria Total Yeast & Mould Specific Organism

14. RAW MATERIALS Refractive Index Acid Value Iodine Value Saponification value Moisture Percentage Microbial presence Total Ash Acid-insoluble ash Iron Assay Microbial Presence pH Extraneous Matter Acid Insoluble Ash Total Ash Moisture Total Sugar Microbial presence

15. FINISHED PRODUCTS pH Specific G ravity Brix Value Alcohol Content Reducing Sugar Non-Reducing Sugar Total Sugar Total Acidity Microbial C ontamination ARISTAM & ASAVAM

16. FINISHED PRODUCTS pH Specific Gravity Brix Value Total Phenolics Microbial contamination KASHAYAM

17. FINISHED PRODUCTS pH Brix Value Moisture/LOD Total Ash Acid – Insoluble A sh Alcohol Soluble Extractives Water Soluble Extractives Total Sugar Microbial Contamination LEHYAM/RASAYANAM

18. FINISHED PRODUCTS pH Moisture/LOD Total Ash Acid – Insoluble Ash Water Soluble Extractives Particle Size Microbial Contamination CHOORNAM

19. FINISHED PRODUCTS Specific Gravity Refractive Index Moisture/LOD Acid Value Iodine Value Viscosity Saponification Value Rancidity Microbial C ontamination GHRUTHAM/MEDICATED OILS

20. Kashayam Tablet – QC Analysis Physicochemical Parameters Average Weight Moisture/LOD Hardness Disintegration Time Friability Total P henolics Microbial P arameters Total Aerobic B acteria Total Yeast & Mould E.coli, Salmonella, S. aureus, Pseudomonas Organoleptic Properties Colour Odour Taste

21. FINISHED PRODUCTS Oil – QC Analysis Organoleptic Properties Colour Odour Physicochemical Parameters LOD/ Moisture Acid Value Iodine Value Saponification Value Refractive Index Rancidity Microbial P arameters Total Aerobic Bacteria Total Yeast & Mould E.coli, Salmonella, S. aureus, Pseudomonas Oil – QC Analysis Organoleptic properties Shell colour Odour Taste Physicochemical Parameters Average w eight of Capsule Moisture/LOD Net weight of oil per capsule Number of drops per capsule Disintegration Time Microbial P arameters Total Aerobic Bacteria TotalY & Mould E.coli, Salmonella S. aureus, Pseudomonas

22. MAJOR INSTRUMENTS

23. MAJOR INSTRUMENTS pH Meter Moisture Analyser Friability Tester DT Apparatus Viscometer Refractometer

24. MAJOR INSTRUMENTS Spectrophotometer Polarimeter BOD Incubator

25. MAJOR INSTRUMENTS Stability Chamber Stability testing of products for Drug licensing Product Quality Assurance Shelf Life Determination Formulation and Packaging Optimization Risk Assessment Product Development and Innovation