Transcript Spesification of raw material, intermediate and final product

Spesification of raw material,
intermediate and final product
• Prepared by: Paras Shah
• Guided by : Dhaval Rathod
• 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.
Sourse of specification
• Pharmacopeal
• In- house
Finished product specification
a. Release specification
b. Stability indicating specification
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.
General concept
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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
Specification on the finished product
Quality characteristic covered by the
specification
a. General charecteristic of p’ceutical dosage
form(eg. Hardnness , friability)
b. Assay of the drug(with known thrapeutic
activity)
c. Identification and assay of excipient
d. Purity test(impurities and microbial
contamination)
 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.
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Specificationmand routine tests for the
release of batches of finished productat the
time of manufature.
Acceptence limits.
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 .
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
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Ophthalmic preparation
Small volume parentral
Large volume parentrals
Suppository
Drug additives