SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED …

1 83_____3AQ11a nSPECIFICATIONS AND CONTROL TESTS ON THEFINISHED PRODUCTG uideline TitleSpecifications and CONTROL TESTS on the FINISHED ProductLegislative basisDirective 75/318/EEC as amendedDate of first adoptionDecember 1991 Date of entry intoforceJune 1992 StatusLast revised 1991 Previous titles/otherreferencesControl of the FINISHED Product/ III/3324/89 Additional NotesThis note for guidance concerns the application of Part 2,section E of the Annex to Directive 75/318/EEC asamended, with a view to the granting of a marketingauthorisation for a new medicinal ANALYSISAPPENDIX85_____3AQ11a nSPECIFICATIONS AND CONTROL TESTS ON THEFINISHED PRODUCTNote for guidance concerning the application of Part 2, section E of the Annex to Directive75/318/EEC as amended.

2 For the purposes of granting a marketing glossary of terms used is included in an appendix to this characteristics covered by the specificationsQuality characteristics cover the following area: general characteristics of the pharmaceutical form, particularly pharmacotechnical;that is to say those characteristics, determined in general by physical TESTS with limitsof acceptance, relating to the product performance or handling ( hardness, friabilityof a conventional tablet); identification of the active substance(s); assay of active substances (and also for herbal medicines, quantitative determinationof the constituents with known therapeutic activity).

3 If necessary, identification and assay of the excipients such as: identification of colorants used, identification and assay of antimicrobial agents or antioxidant preservatives (withacceptance limits); purity TESTS (if necessary, the investigation of breakdown products, residual solvents orother process related impurities, microbial contamination); pharmaceutical TESTS ( dissolution); safety TESTS including abnormal or specific toxicity TESTS , where applicable, i nparticular for biological order to determine the SPECIFICATIONS of the FINISHED product.

4 The quality characteristicsrelated to the manufacturing process should be taken into appropriate specification for each aspect of quality studied during the phase ofdevelopment and during the validation of the manufacturing process should be least those aspects considered to be critical should be the object of SPECIFICATIONS Relationship between dossier SPECIFICATIONS and thePharmacopoeiaThe general provisions of the European Pharmacopoeia describe and define the content andlegal weight of the various sections of its monographs and general 3AQ11a_____Directive 75/318/EEC as amended recapitulates those aspects of quality which must be theobject of appropriate SPECIFICATIONS by referring to the general monographs of the EuropeanPharmacopoeia or, failing this, to pharmacopoeias of Member monographs on medicinal products.

5 The European or national pharmacopoeiaedefine the reference quality level. In the marketing authorisation application, the applicantshould determine the most appropriate means for reaching the stated objective, and supply theappropriate analytical validation data. In all cases, routine TESTS on the FINISHED product atrelease follow the stipulations of section addition, as a result of the fact that these monographs correspond to regulatoryspecifications, they represent the limit values of medicinal product at the end of their shelflife (except for those provisions referring to production).

6 The SPECIFICATIONS for release of thefinished product must comply with the criteria defined by Directive 75/318/EEC as amended, 5% for the assay of active substance(s) except when otherwise Relationships between the specification of a FINISHED product atthe end of shelf life and at manufacture (at release)a )The aim of the application dossier for a marketing authorisation is to set the qualitylevel of the medicinal product as intended for marketing.

7 It establishes SPECIFICATIONS , qualitative and quantitative characteristics, with test procedures and acceptancelimits, with which the medicinal product must comply during its intended shelf Part II F of the dossier, the applicant proposes a shelf life for the medicinal productmainly on the basis of the level of active constituents (efficacy) and the admissiblelevel of any breakdown products or impurities (safety) and consistentpharmacotechnical properties.

8 From the behaviour of the medicinal product theapplicant deduces the appropriate storage conditions which will maintain compliancewith the SPECIFICATIONS of the medicinal )The specification limits of the FINISHED product at the time of batch release are set by themarketing authorisation applicant such that the SPECIFICATIONS proposed at the end ofshelf life are guaranteed; they are established on the basis of a critical detailed reviewof the data gathered from the batches analysed.

9 Nevertheless, acquired experience is afactor recognised to be very important in terms of good manufacturing practice. One ofthe basic requirements of GMP (see the Guide to GMP) is the systematic review of a l lmanufacturing processes in the light of experience. Thus, the applicant, in compliancewith Directive 65/65/EEC as amended, Article 9. a, shall adapt or refine thespecifications at release as a function of experience acquired by the manufacturer(s) ofthe medicinal )

10 The SPECIFICATIONS of the FINISHED product at manufacture may be different from thoseof the medicinal product at certain cases, for characteristics of the medicinal product which may change duringstorage under the approved conditions, the quality required at the end of shelf lifeshould be taken into account in determining appropriate SPECIFICATIONS at the time ofmanufacture, for example in the case of overages for reasons of is desirable that all SPECIFICATIONS (characteristics and acceptance limits) of themedicinal product and the FINISHED product at the time of release be presented in the87_____3AQ11a nform of a summary table.