pharamacopoeial standards

RAGHAVA REDDY.KRATNAM INSTIUTE OF PHARMACY

NELLOR EANDHRA PRADESH

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Why we need standards ?

How we can frame the standards ?

What is pharmacopoeia ?

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Scientific body Subject experts Representatives of CDSCO State regulatory authorities Specialist from industries Associations ,councils...

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Pharmacopoeia in 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.

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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.

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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.

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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

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Pharmacopoeial standards are the minimum ones

Acceptable levels of change

Strong compliance between GMP and pharmacopoeial standards

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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

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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

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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

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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

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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.

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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.

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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.

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Decision making capacity : which monograph we have to introduce[include] or exclude.

Based on the adverse effects , indications, prevalence of the disease.

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THALIDOMIDE-cons

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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

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Expression of terms used in pharmacopoeia should be clear…..

Ex: negligible freshly prepared cold freezing temperature

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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

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TITLE INN Chemical formula A.W&M.WCATEGORY description DOSE usual strengthIDENTIFICATION assay SOLUBILITY structure