guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
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Guidelines <strong>on</strong> Variati<strong>on</strong>s <strong>to</strong> a Registered Pharmaceutical ProductAuthority: The Nati<strong>on</strong>al Drug Authority (NDA)Biobatch: The batch used <strong>to</strong> establish bioequivalence or similarity <strong>to</strong> thecompara<strong>to</strong>r <strong>product</strong> as determined in bioequivalence or biowaiver studies,respectively.Finished <strong>pharmaceutical</strong> <strong>product</strong> (FPP): A finished dosage form of a<strong>pharmaceutical</strong> <strong>product</strong> which has underg<strong>on</strong>e all stages of manufactureincluding packaging in its final c<strong>on</strong>tainer and labelingIn-process c<strong>on</strong>trol: Check performed during manufacture <strong>to</strong> m<strong>on</strong>i<strong>to</strong>r or <strong>to</strong>adjust the process in order <strong>to</strong> ensure that the final <strong>product</strong> c<strong>on</strong>forms <strong>to</strong> itsspecificati<strong>on</strong>s.Manufacturer: A company that carries out operati<strong>on</strong>s such as <strong>product</strong>i<strong>on</strong>,packaging, repackaging, labelling and relabelling of <strong>pharmaceutical</strong>sOfficially recognized pharmacopoeia (or compendium): Thosepharmacopoeias recognized by NDA (i.e. The Internati<strong>on</strong>al Pharmacopoeia(Ph.Int.), the European Pharmacopoeia (Ph.Eur.), the British Pharmacopoeia(BP), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia(USP)).Pilot scale batch: A batch of an API or FPP manufactured, by a procedure fullyrepresentative of and simulating that <strong>to</strong> be applied <strong>to</strong> a full <strong>product</strong>i<strong>on</strong> scalebatch. For example, for solid oral dosage forms, a pilot scale is generally, at aminimum, <strong>on</strong>e-tenth that of a full <strong>product</strong>i<strong>on</strong> scale or 100,000 tablets or capsules,whichever is the larger, unless otherwise adequately justified.Producti<strong>on</strong> batch: A batch of an API or FPP manufactured at <strong>product</strong>i<strong>on</strong>scale by using <strong>product</strong>i<strong>on</strong> equipment in a <strong>product</strong>i<strong>on</strong> facility as specified in theapplicati<strong>on</strong>Stringent regula<strong>to</strong>ry authority (SRA): A stringent regula<strong>to</strong>ry authority is:a) the medicines regula<strong>to</strong>ry authority in a country which is: (a) a member ofthe Internati<strong>on</strong>al C<strong>on</strong>ference <strong>on</strong> Harm<strong>on</strong>izati<strong>on</strong> (ICH) (European Uni<strong>on</strong>(EU), Japan and the United States of America); or (b) an ICH Observer,being the European Free Trade Associati<strong>on</strong> (EFTA) as represented bySwissMedic and Health Canada (as may be updated from time <strong>to</strong> time);or (c) a regula<strong>to</strong>ry authority associated with an ICH member through alegally-binding, mutual recogniti<strong>on</strong> agreement including Australia, Iceland,Liechtenstein and Norway (as may be updated from time <strong>to</strong> time); andDoc. No.: DAR/GDL/005 Revisi<strong>on</strong> Date: 8 th July 2013 Review Due Date: 16 th July 2016Revisi<strong>on</strong> No.: 1 Effective Date : 16 th July 2013 Page 7 of 70