The document discusses pharmacopoeial standards and the Indian Pharmacopoeia. It explains that standards are created by a scientific body to provide minimum quality standards for drugs. Standards aim to balance desirable quality with what is achievable for manufacturers. Monographs include identification tests, purity tests, limits for impurities and dosage information. Test methods are clearly described to allow replication in various laboratories. The history and process for developing the Indian Pharmacopoeia are also summarized.

1. pharamacopoeial standards RAGHAVA REDDY.K RATNAM INSTIUTE OF PHARMACY NELLOR E ANDHRA PRADESH 12/30/2010 1

2. Why we need standards ? How we can frame the standards ? What is pharmacopoeia ? 12/30/2010 2

3. Scientific body Subject experts Representatives of CDSCO State regulatory authorities Specialist from industries Associations ,councils... 12/30/2010 3

4. Pharmacopoeiain its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society. 12/30/2010 4

5. OBJECTIVE The overall objective has been the creation of a compilation of standards that reflect the state of the industry in the country and the production and testing capabilities of units varying in size from the small to the very big. 12/30/2010 5

6. Priority given to monographs of drugs included in the National Essential Drugs List and their dosage forms. Regular upgradation of monographs but consistent with the level and degree of sophistication acceptable to the majority of manufacturers. Harmonization of IP standards with international acceptance criteria for drug quality. 12/30/2010 6

7. QUALITY STANDARDS A compromise between the desirable and the achievable Retention of simple tests where complicated methods offer no advantage No compromise on limitation of toxic impurities Gradual tightening of standards over the years 12/30/2010 7

8. Pharmacopoeial standards are the minimum ones Acceptable levels of change Strong compliance between GMP and pharmacopoeial standards 12/30/2010 8

9. The primary focus of the pharmacopoeia has been provision of standards for licensed products Prescribing standards for labeling and packaging Considerable support must be given to the traditional medicines 12/30/2010 9

10. NORMAL FORMATE Description: Physical form of the material, whether hygroscopic, odour, and indication of polymorphism, if applicable Identification Tests usually including infrared spectrometry, if appropriate Non-specific purity tests, such as light absorption, optical rotation, sulphated ash etc 12/30/2010 10

11. Impurities may result from manufacturing process or by degradation of product during storage Impurities other than related substances that may require control such as heavy metals, inorganic impurities, residues of solvents and reagents used during synthesis and purification 12/30/2010 11

12. Storage guidelines considering different geographical atmosphere Other tests such as loss on drying Assay and limits for purity calculated on the anhydrous, dried or solvent-free basis, as appropriate 12/30/2010 12

13. The requirements given in the monographs are not framed to provide against all possible impurities, contaminants or adulterants; they provide appropriate limitation of potential impurities only. 12/30/2010 13

14. Identification tests based on those for the parent drug substance, where applicable, with suitable details for isolation of the active ingredient from the excipients. Impurities as in the case of drug substances but additionally including those arising on manufacture or storage of the dosage form. 12/30/2010 14

15. TEST METHODS Pharmacopoeial methods usually prescribe the use of testing equipment available to most manufacturers and public testing laboratories. Test methods are described in a clear language and in sufficient detail that they can be followed in any laboratory by a trained analyst. 12/30/2010 15

16. Decision making capacity : which monograph we have to introduce[include] or exclude. Based on the adverse effects , indications, prevalence of the disease. 12/30/2010 16

17. THALIDOMIDE-cons 12/30/2010 17

18. ANTI-CANCER DRUGS-pros They have serious adverse effects but because of their indications we have to continue in the treatment………. They have serious adverse effects like alopecia neurotoxicity nephrotoxicity cardiotoxicity HERE PROS &CONS MEANS POSITIVE & NEGATIVE 12/30/2010 18

19. Expression of terms used in pharmacopoeia should be clear….. Ex: negligible freshly prepared cold freezing temperature 12/30/2010 19

20. HISTORY OF IP Process started in the year 1944 under COL sri R.N CHOPRA First publication in the year 1946 First edition in the year 1955 1966 1985 1996 2007 2010 12/30/2010 20

21. TITLE INN Chemical formula A.W&M.W CATEGORY description DOSE usual strength IDENTIFICATION assay SOLUBILITY structure 12/30/2010 21