This document outlines specifications and testing procedures for pharmaceutical products. It discusses the need to validate testing procedures before adopting them routinely. It also describes the requirements for specifications of starting materials, packaging materials, intermediate and bulk products, and finished products. Specifications should include a description of the material, reference standards, qualitative and quantitative requirements, storage conditions, and expiration dates. Periodic revision may be necessary to comply with pharmacopoeia standards.

1. SRIKRUPA INISTITUTE OF PHARMACEUTICAL SCIENCES
(Approved by AICTE; PCI)
(Affiliated to Osmania University)
ASSIGNMENT ON
SPECIFICATIONS AND TESTING PROCEDURES
SUBMITTED BY
HUZAIFA NAAZ

2. Specifications and testing procedures
15.13 Testingproceduresdescribedindocumentsshouldbe validatedinthe contextof available
facilitiesandequipmentbefore theyare adoptedfor routine testing.
15.14 There shouldbe appropriatelyauthorizedanddatedspecifications, includingtestsonidentity,
content,purityandquality,forstartingand packagingmaterialsandforfinishedproducts;where
appropriate,they shouldalsobe available forintermediateorbulkproducts.Specifications
for water,solventsandreagents(e.g.acidsandbases) usedinproduction shouldbe included.
15.15 Each specificationshouldbe approved,signedanddated,andmaintained bythe QCor QA units.
Specificationsforstartingmaterials,intermediates, bulk,finishedproductsandpackagingmaterialsare
referredtoinsections 15.18–15.21.
15.16 Periodicrevisionsof the specificationsmaybe necessarytocomplywith new editionsof the
national pharmacopoeiaorotherofficial compendia.
15.17 Pharmacopoeias,reference standards,reference spectraandother reference materialsshouldbe
available inthe QClaboratory.
Specificationsfor starting and packaging materials
15.18 Specificationsforstarting,primaryandprintedpackagingmaterialsshould provide,if applicable,a
descriptionof the materials,including:
(a) the designatedname (if applicable,the INN) andinternal code reference;
(b) the reference,if any,toa pharmacopoeial monograph;
(c) qualitative andquantitative requirementswithacceptance limits. Dependingonthe company’s
practice otherdata may be addedto the specification,suchas:
(a) the supplierandthe original producerof the materials;
(b) a specimenof printedmaterials;
(c) directionsforsamplingandtesting,ora reference toprocedures;
(d) storage conditionsandprecautions;
(e) the maximumperiodof storage before reexamination. Packagingmaterial shouldconformto
specifications,andshouldbe compatible withthe material and/orwiththe medicinesitcontains.The
material shouldbe examinedforcompliance withthe specification,andfordefectsaswell asforthe
correctnessof identitymarkings.
15.19 Documentsdescribingtestingproceduresshouldstate the required frequencyforre-assaying
each startingmaterial,asdeterminedbyits stability.
Specificationsforintermediate and bulk products
15.20 Specificationsforintermediate andbulkproductsshouldbe available. The specificationsshouldbe
similartospecificationsforstartingmaterials orforfinishedproducts,asappropriate.
Specificationsforfinishedproducts
15.21 Specificationsforfinishedproductsshouldinclude:
(a) the designatedname of the productand the code reference, where applicable;
(b) the designatedname(s) of the active ingredient(s) (ifapplicable, withthe INN(s));
(c) the formulaora reference tothe formula;
(d) a descriptionof the dosage formandpackage details;
(e) directionsforsamplingandtestingora reference toprocedures;
(f) the qualitative andquantitativerequirements,withacceptance limits;
(g) the storage conditionsandprecautions,whereapplicable;
(h) the shelf-life.