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Click to edit Master text styles,Second Level,Third Level,Fourth Level,Fifth Level,Click to edit Master title style,Module 11Slide,*,of 19,WHO-EDM,Basic Principles of GMP,Materials,Part One Section 13,Materials,Objectives,To review specific requirements for each type of material:,Starting materials,Packaging materials,Intermediate and bulk products,Finished products,Rejected and recovered materials,Recalled products,Returned goods,Reagents and culture media,Reference standards,Waste materials,Miscellaneous materials.,To examine(in groups)the problems associated with materials,and how to overcome them,.,Materials,Principle,Objective of the pharmaceutical manufacturer:,produce finished products,combination of materials,Materials combined:,active pharmaceutical ingredients,auxiliary materials(excipients),packaging materials,Special attention,Part One 13.213.3,Materials,General requirements for materials,All incoming materials and finished products:,quarantined after receipt,until released for use,distribution,stored,under appropriate conditions,orderly fashion(batch segregation),materials management,stock rotation(FIFO or EEFO),Part One 13.413.7,Materials,Starting Materials I,Purchasing,Suppliers,Consignment:,integrity,seal,order,delivery note,suppliers labels,Cleaned and labelled,Part One 13.813.11,Materials,Starting Materials II,Damaged containers,Different batches in one consignment,Starting material label:,name and internal code,batch number(s),(supplier and manufacturer on receipt),status,expiry date or re-test date,Sampled containers identified,Materials,Examples of Labelling of Starting Materials,Part One 13.1213.15,Materials,Starting Materials III,Use only released material,Dispensing:,designated persons,written procedure,accurately weighed,clean,labelled containers,Independent checks,material and weight,Dispensed material:,kept together and labelled,Part One 13.1613.20,Materials,Packaging materials I,Primary and printed materials:,as for starting materials,purchasing,handling and control,No unauthorized access,Storage and transport,avoid mix-ups,issue and return:SOP,Part One 13.1613.20,Materials,Packaging materials II,Specific reference number for batch or consignment,Packaging department checks:,quantity,identity and conformity,Outdated or obsolete material,Part One 13.2113.22,Materials,Intermediate and bulk products,Appropriate conditions,Purchased:,as starting materials,Part One 13.2313.24,Materials,Finished products,Quarantine until released,Storage conditions,Evaluation and documentation,product release,Part One 13.2513.28,Materials,Rejected and recovered materials,Rejected materials,Clearly marked,Stored separately in restricted areas,Action,Reprocessing:,exceptional,procedure and records,batch number,additional testing,Part One 13.2513.28,Materials,Rejected and recovered materials,Recovery:,prior authorization,additional testing,Part One 13.2913.30,Materials,Recalled products and returned goods,Recalled products:,identified,stored separately,access controlled,fate,Returned goods:,SOP:decision regarding the fate,nature of product,storage conditions,history,time lapse,records,Part One 13.3113.33,Materials,Reagents and culture media,Recorded upon receipt or preparation,Reagents:,preparation in accordance with SOP,label:,concentration,standardisation factor,shelf-life,date that re-standardisation is due,storage conditions,signed and dated,Culture media:,positive and negative controls,Part One 13.3413.37,Materials,Reference standards,Official reference standards,use only as per monograph,storage,Reference standards prepared by the producer:,tested,released,stored in same way as official reference standards,Secondary or working standards:,appropriate checks and tests,regular intervals,based on official reference standards,Part One 13.3813.40,Materials,Waste materials and miscellaneous materials,Waste materials,proper and safe storage,toxic and flammable materials,separate,enclosed,as per legislation,not allowed to accumulate,collected for safe disposal,regular intervals,Miscellaneous,rodenticides,insecticides,sanitizing material,contamination risks,
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