Spesification of raw material, intermediate and final product

1. Spesification of raw material, intermediate and final product • Prepared by: Paras Shah • Guided by : Dhaval Rathod

2. Specification : • Specification is define as a list of test, reference to analytial procedure, and appropriate acceptence criteria which are numerical limits, range or other criteria for the test described. Specification mainly descibe in detail the requirement with which products or material used or obtaied during manufacturing have to confirm. • Specification are critical quality standards that are proposed and justified the manufacturer and approved by regulatory authorities as condition of approval.

3. Sourse of specification • Pharmacopeal • In- house • Finished product specification • Release specification • Stability indicating specification

4. Objective of finished product specification • The objective of specification is to assure that each unit contains the amount of drug claimed on the lable, that all the drug in each unit is available for complete use, the drug stable in the formulation in its specific final container for its expected shelf life and that it contain no toxic foreign substance.

5. General concept • Periodic and skip testing • Release vs shelf life acceptence criteria • In process test • Design and development consideration • Availibility of specific data • Parameter release • Alternative anlytical procedure • Pharmacopeal test and acceptence criteria • Impact of drug substance on drug product specification • Reference standard

6. Specification on the finished product • Quality characteristic covered by the specification • General charecteristic of p’ceutical dosage form(eg. Hardnness , friability) • Assay of the drug(with known thrapeutic activity) • Identification and assay of excipient • Purity test(impurities and microbial contamination)

7. Relationship between dossier specification and the pharmacopoiea. • Relationship between the specification of a finished product at the end of shelf life and at manufacture. • The aim of applicantion dossier for a marketing authorisation is to set the quality level of the medicinal product as intended for marketing . • The specification limit of the finished product at a time of batch release are set by the marketing authorisation applicant such that the specification proposed at the end of shelf life are guaranteed. • The specification of the finished product may be different from those of the medicinal product at expiry. .

8. Specificationmand routine tests for the release of batches of finished productat the time of manufature. • Acceptence limits.

9. Specification for documentation of the p’ceutical finished product • The designated name of the product and code. • The desiignated name of the active ingradient. • The formula or reference to formula. • A description of dosage form and the pakaged detail. • Direction for sampling and testing .

10. Specification for storage of p’ ceutical finished product • General acceptable specification for drug product. • General • Specific • Tablet • Capsule • Emultion • Oral solution and susp. • Metered dose inhaler

11. Ophthalmic preparation • Small volume parentral • Large volume parentrals • Suppository • Drug additives