Analysis of raw material and finished product

Analysis of raw material and finished product

1. PRESENTD BY :- PATIL PRANJAY SADASHIV. FIRST YEAR M.PHARM. DEPARTMENT OF QUALITY ASSURANCE. H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur ANALYSIS OF RAW MATERIAL AND FINISHED PRODUCT

2. Content:

3. Raw Material 1 A raw material or feedstock is basic material used in the production of good, finished product or intermediate. Ex. Crude oil is raw material providing finished product in fuel Raw material used by non human species . Ex. Twings object as used by bird to make nests . Raw material are often natural resources. Ex. Iron, oil and wood Raw material is called as factor market because raw material are factor of production along with labor. Raw material can be either active drug or inactive substance.

4. Two sub categories of raw material Direct raw material : Directly incorporated into in final product. Indirect raw material : Those which are consumed during the production process .

5. Diagramatic Presentation

6. Criteria For Raw Material 1 It must be noted that P harmacopoeial standard are minimum. Supplier of received material should have his name listed in companies approved vendor list, such list should be available in receiving dept. All raw material and related material should be check following point: a)Name of the manufacture b)Name of the product c)Batch no., Mfg date and Exp. Date Sampling of raw material should be received by Q.C person and container should be labelled accordingly.

7. Specification should include at least requirement for identification ,limit for purity & potency and limit for impurities. All received material must be properly identified with their status (receive, reject approved and material identification like code no., product name) If one delivery of material is made up of different batches each batch must be considered as separated for sampling, testing and release. Container from which samples have been taken out should be identified Only material released by Q.C dept. and within their shelf life should be used. All dispensed material must be recorded in a register in chronological order of date & time.

8. Role of Raw Material Management 1 Availability of raw material in the right quality and quantity will determine to a reasonable extent. Determination of economic order (EOQ), Reorder level and minimum & maximum stock level. Material management being the coordination of efforts (planning controlling), toward achieving efficiency in transportation and stocking.

9. Quality Control of Raw Material 2 water

10. Water is imp. Raw material in food industry. Maintenance of living organism. It is used in many technological process including the cleaning of raw material Occurrence of water in food depend on the physical &chemical composition of the natural food product. Force of hydrogen bonding & capillary action also characterized the occurrence of water in food. Where, P=partial V.P of food Po= V.P of pure water at same temp . Water activity(Aw)=   Water 2

11. Food Aw Meat, egg 0.97-0.98 Bread, cheese 0.97 Fruit jam 0.82 sugar 0.10 Microbiological study Aw Bacteria 0.94 Yeasts 0.90 Molds 0.75 Yeast osmophillic 0.60

12. Water activity influence the rate of reaction, lipid oxidation, non enzymatic browning, sucrose hydrolysis, chlorophyll degradation. Indices Requirement Appearance colorless pH 6-8 Total soluble matter Al Mg Oil substance Mostly 1000 0.2 0.125 0.005

13. Raw Material of Plant Origin 2 1)CEREALS 2)FRUIT & VEGETABLES 3) OILS SEED 4) LEGUMES

14. Consumption of cereals provide the energy & protein to the population. Cereals protein are generally of relatively poor nutritional quality In developing countries, M ore than 80% - plant origin protein More than 60% - cereals Only 40% - total protein consumption Cereals as R.M. graded on the basis of their physical property – size ,shape, color, hardness and % of damaged grain CEREALS 2

15. Cereals Water Protein Lipid Starch Wheat 13.2 11.7 2.2 59.2 Rye 13.7 11.6 1.7 52.4 Oats 13 12.6 5.7 40.1 Rice 13.1 7.4 2.4 70.4 Corn 12.5 9.2 3.8 62.6 Major wheat protein fractions are the gliadin & glutenin , comprising protein in an approximately ratio 1:1 Cereals are higher water activity the danger of presence of toxic metabolic product of different fungi’s mycotoxin may occur.

16. Procedure is include in fruit and vegetables import requirement (FAVIR) Database. Approved fruit and vegetables are- FRUIT & VEGETABLES 2

17. Raw Material Of Animal Origin The raw material of animal origin are less well known than the plant origin R.M. Ambergris is a substance secreted by the intestine of a sperm whale & is ejected naturally. It is very expensive & valuable substance used in perfume making. Musk is a well known example is used for the fragrance in perfume industry. Strong smelling granule contain in a pocket under the belly of deer. Castor is an odoriferous secretion produced by beaver gland.

18. Authorized officer & official veterinary surgeon are involved with checking these product:

19. Cont …… 1)Meat 2)Egg 3)Milk

20. Soap are used in egg production facilities to clean the shell. Egg production is spurred by maintaining of lighted environment (4-7 hr /day) Effective candling is essential to quality control.( age, clarity) Salmonella hazard to the pharmaceutical product so govt. approval soap are used for the cleaning purpose. & it is 90% free from bacteria. Egg 2

21. Egg farmers are also careful to refrigerate the eggs as soon as they are gathered just prior to packing . Government standards for the grade and size of eggs are strictly adhered to. Flocks are periodically monitored for proper feeding as well as acceptable facility standards. Egg size gm Extra large 2.24(64gm) Large 1.96(56gm) Medium 1.72(49gm) Small 1.47(42gm)

22. Other Raw Material 2 1)Sugar 2)Salt 3)Spices

23. Sugar cane used as R.M for ethanol production. Composition of-stalk(81.2%),palm(6.1%),green leave (5.6%) During fermentation water (75-82%),soluble solid(10-25),sugar (15-24%) change due to several factor. Sugar 2

24. Waste water treatment Boiler Ethanol Enzyme production Evaporation Evaporation Process:

25. Rapid test kit(RTK):- Test the salt absence or presence of iodine Salt factories and lab. Should not use RTK in their quality management system. Reliable & inexpensive analytical method used for measuring iodine content is called as Iodometric titration. To check humidity, foreign matter & purity.

26. Finished product are product which are in the marketable pack. These product should be held in quarantine until their final release. Practically a transportable pack i.e shipper contain a salable pack Each batch of the finished product should be tested as per the sop and then release the product for sale or distribution Finished Product 2,3

27. Specification And C ontrol test 4 Specification Dossier specification Specification of finished product Acceptance limit Test procedure Batch analysis

28. Specification 4 1) Quality characteristics :- Determine general physical test with limit of acceptance, product performance & handling Identified active substance & assay of substance Identification of colorant used Purity test, pharmaceutical test(dissolution) Toxicity test

29. 2) Relationship between dossier specification and pharmacopoeia:- Monograph correspond to regulatory specification they represent the limit value of medical product at the end of their shelf life 3 ) Relationship between specification of product and manufacturer:- The specification of the finished product at mfg. may be different from those of the medicinal product at expiry The specification limit of the finished product at the time of batch release are set by market authorization .

30. 4)Acceptance limit:- Release limit of further justification. Relese limit wider than means vriation of both production and test procedure. Release limit primarily concern the mfg. of the product. 5)Test procedure:- Control method must be validated in accordance with validation of analytical procedure. Analytical result can not be dissociate from the method used.  

31. 6) Batch analysis:- Result obtained all specification at release, whether or not are intended to be verified batch to batch The consecutive batches should corresponds to production scale batches mfg. by all manufacturer. If these data are not available for industrial scale batches , they should be supplied to authority.

32. Conclusion For each raw material quality control test has been specified and standardized by pharmacopoeia. Testing criteria for selection of raw materials to finished product manufacturing process in every industry has specific protocols and limits. Finished product is a medical product which has under gone all stage of production including packaging.

33. References M anohar A. Potdar “PHARMACEUTICAL QUALITY ASSURANCE ” nirali prakashan fifth edition 2016, page no-4.2 to 4.5 Jiri Davidek , “Quality control of raw material” Institute of chemical and food technology, prague , Czech republic food quality and standards volume 2. www.madehow.com  ›  Volume 5 “Control of finished product” III/3324/89 Specification and control test on the finished product directive 75/318/EEC as amended, December 1991, Page no-83-91