Basic Principles of GMP Materials 14 Module 11
Basic Principles of GMP Materials 14 Module 11 | January 2006 Slide 1 of 25 STOP
Materials Objectives l To review specific requirements for each type of material: ä Starting materials ä Packaging materials ä Intermediate and bulk products ä Finished products ä Rejected and recovered materials ä Recalled products ä Returned goods ä Reagents and culture media ä Reference standards ä Waste materials ä Miscellaneous materials l To examine (in groups) the problems associated with materials, and how to overcome them Module 11 | January 2006 Slide 2 of 25 STOP
Materials Principle l Objective of the pharmaceutical manufacturer ä produce finished products for patient's use from a combination of materials l Materials combined ä Active pharmaceutical ingredients and ä Excipients (auxiliary materials) ä Packaging materials l Materials include also ä Gases, solvents, reagents, process aids, etc. ä Special attention Module 11 | January 2006 Slide 3 of 25 STOP 14. 1, 14. 2
Materials General requirements for materials l Materials for cleaning, lubrication, and pest control ä Not in direct contact with product ä Suitable grade, e. g. food grade if possible l All incoming materials and finished products ä quarantined after receipt or processing – until released for use or distribution ä stored – under appropriate conditions – orderly fashion (batch segregation) – materials management – stock rotation (FEFO) l Water – suitable for use Module 11 | January 2006 Slide 4 of 25 STOP 14. 3– 14. 6
Materials Starting Materials – I l Purchasing – important operation l From approved suppliers – if possible, direct from the manufacturer l Specifications for materials l Consignment checks ä Integrity of package ä Seal intact ä Corresponds with the purchase order ä Delivery note ä Supplier’s labels l Cleaned and labelled with information 14. 7 – 14. 10 Module 11 | January 2006 Slide 5 of 25 STOP
Materials Starting Materials – II l Different batches in one delivery/consignment l Starting materials labelled ä name and internal code ä Supplier's batch number(s) and manufacturer's on receipt ä Status (e. g. quarantine, on test, etc. ) ä expiry date or retest date Role of validated computer systems l "Sampled" containers identified Module 11 | January 2006 Slide 6 of 25 14. 11 – 14. 14 STOP
Basic Principles of GMP Module 11 | January 2006 Slide 7 of 25 STOP
Basic Principles of GMP l Damage to and problems with containers ä Recorded and reported to QC ä Investigated Module 11 | January 2006 Slide 8 of 25 STOP
Materials Examples of Labelling of Starting Materials Module 11 | January 2006 Slide 9 of 25 STOP
Materials Starting Materials – III l Use only QC released material if within shelf-life l Dispensing ä designated persons ä written procedure ä Correct materials accurately weighed ä clean, properly labelled containers l Independent checks and record ä material and weight or volume l Dispensed material ä kept together and labelled 14. 15 – 14. 18 Module 11 | January 2006 Slide 10 of 25 STOP
Basic Principles of GMP Module 11 | January 2006 Slide 11 of 25 STOP
Materials Packaging materials - I l Primary and printed packaging materials ä purchasing, handling and control – as for starting materials l Printed packaging materials: particular attention ä Stored in secure conditions with authorized access ä Roll labels where possible in place of cut labels ä Loose materials stored and transported in separate, closed containers - to avoid mix-ups ä Issued by designated personnel 14. 25– 14. 20 ä SOP for issue and returns Module 11 | January 2006 Slide 12 of 25 STOP
Basic Principles of GMP Module 11 | January 2006 Slide 13 of 25 STOP
Materials Printed and primary packaging materials - II l Each delivery or batch: specific reference number or identification mark l Delivery to packaging department ä Check quantity, identity and conformity to packaging instructions l Outdated or obsolete material ä Destroyed ä Disposal record 14. 21 – 14. 23 Module 11 | January 2006 Slide 14 of 25 STOP
Basic Principles of GMP Intermediate and bulk products l Kept under appropriate conditions l If purchased as such ä Handled on receipt as though these are starting materials 14. 24 – 14. 25 Module 11 | January 2006 Slide 15 of 25 STOP
Basic Principles of GMP Finished products l Held in quarantine until their final release l Then stored as usable stock under suitable storage conditions l Evaluation and documentation necessary for release ä Product release procedure ä Batch record review and related procedure Module 11 | January 2006 Slide 16 of 25 14. 26 – 14. 27 STOP
Materials Rejected, reworked and recovered materials l Rejected materials and products ä Clearly marked ä Stored separately in restricted areas ä Action – returned to supplier/destroyed, etc. in timely manner ä Action approved by authorized personnel – records maintained 14. 28 Module 11 | January 2006 Slide 17 of 25 STOP
Materials Rejected, reworked and recovered materials l Rework and recovery ä Should be exceptional cases ä Only if: – Risks involved have been evaluated and the quality of final product will not be affected – Specifications are met – Defined procedure – Records maintained 14. 29 – 14. 30 – New batch number ä additional testing to be considered by QC Module 11 | January 2006 Slide 18 of 25 STOP
Materials Recalled products and returned goods l Recalled products ä Identified ä Stored separately ä Secure area - access controlled ä Decision taken on their fate l Returned goods ä Destroyed unless suitable quality ä SOP: decision regarding their fate (relabelling, resale, etc. ) – Consider: nature of product, special storage conditions, condition, history, time elapsed since issue 14. 32 – 14. 33 ä Action taken to be recorded Module 11 | January 2006 Slide 19 of 25 STOP
Materials Reagents and culture media l Records for receipt or preparation l Reagents ä Preparation in accordance with SOP ä Appropriately labelled: – concentration, standardization factor, shelf-life, date that restandardization is due, storage conditions – signed and dated l Culture media ä positive and negative controls each time prepared and used ä Inoculum size appropriate 14. 34 – 14. 36 Module 11 | January 2006 Slide 20 of 25 STOP
Materials Reference standards - I l Official reference standards ä Use preferable whenever these exist ä Only for the purpose as per monograph ä Storage conditions l Reference standards prepared by the producer ä Tested, released and stored in the same way as official standards ä In a secure area ä A responsible person l Secondary or working standards 14. 37 – 14. 40, 14. 42 ä Appropriate checks and tests at regular intervals ä Standardized against official reference standards – initially and at regular intervals Module 11 | January 2006 Slide 21 of 25 STOP
Materials Reference standards - II l Reference standards labelled with information including ä Name ä Batch, lot or control number ä Date of preparation ä Shelf-life ä Potency ä Storage conditions l Stored and used in an appropriate manner 14. 41, 14. 43 Module 11 | January 2006 Slide 22 of 25 STOP
Materials Waste materials l Waste materials ä proper and safe storage when awaiting disposal ä toxic substances and flammable materials: – in suitably designed, separate, enclosed areas as per national legislation ä not to be allowed to accumulate – collected in suitable containers for removal to collection points – safe and sanitary disposal – regular and frequent intervals 14. 44 Module 11 | January 2006 Slide 23 of 25 STOP
Materials Miscellaneous materials l Miscellaneous ä Rodenticides, insecticides, fumigating agents ä Sanitizing material ä No contamination risk to equipment, starting materials, packaging materials, in-process materials, finished products 14. 45 Module 11 | January 2006 Slide 24 of 25 STOP
Materials Group session l List specific aspects of GMP requirements, in relation to the groups of materials listed below, that you would assess when inspecting a manufacturer ä Printed packaging materials ä Thermolabile materials ä Water ä Sterile materials l Identify three materials that present problems in your experience l What are some of the problems that you have experienced before and during inspection of materials? Module 11 | January 2006 Slide 25 of 25 STOP
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