Basic Principles of GMP Materials Module 11 | Slide 1 of 25 January 2006 Materials Objectives To review specific requirements for each type of material: Starting.
Download ReportTranscript Basic Principles of GMP Materials Module 11 | Slide 1 of 25 January 2006 Materials Objectives To review specific requirements for each type of material: Starting.
Basic Principles of GMP Materials 14 Module 11 | Slide 1 of 25 January 2006 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 Module 11 | Slide 2 of 25 January 2006 Materials Principle Objective of the pharmaceutical manufacturer produce finished products for patient's use from a combination of materials Materials combined Active pharmaceutical ingredients and Excipients (auxiliary materials) Packaging materials Materials include also Gases, solvents, reagents, process aids, etc. Special attention Module 11 | Slide 3 of 25 January 2006 14.1, 14.2 Materials General requirements for materials Materials for cleaning, lubrication, and pest control Not in direct contact with product Suitable grade, e.g. food grade if possible All incoming materials and finished products quarantined after receipt or processing – until released for use or distribution stored – under appropriate conditions – orderly fashion (batch segregation) – materials management – stock rotation (FEFO) Water – suitable for use Module 11 | Slide 4 of 25 January 2006 14.3–14.6 Materials Starting Materials – I Purchasing – important operation From approved suppliers – if possible, direct from the manufacturer Specifications for materials Consignment checks Integrity of package Seal intact Corresponds with the purchase order Delivery note Supplier’s labels Cleaned and labelled with information 14.7 – 14.10 Module 11 | Slide 5 of 25 January 2006 Materials Starting Materials – II Different batches in one delivery/consignment Starting materials labelled name and internal code Supplier's batch number(s) and manufacturer's on receipt Status (e.g. quarantine, on test, etc.) expiry date or retest date Role of validated computer systems "Sampled" containers identified Module 11 | Slide 6 of 25 January 2006 14.11 – 14.14 Basic Principles of GMP Module 11 | Slide 7 of 25 January 2006 Basic Principles of GMP Damage to and problems with containers Recorded and reported to QC Investigated Module 11 | Slide 8 of 25 January 2006 Materials Examples of Labelling of Starting Materials Name of Material and/or internal code Control/ Batch No. Quarantined/Released/Rejected (Colours may be used) Status Expiry date or retest date Date Module 11 | Slide 9 of 25 Signature January 2006 Materials Starting Materials – III Use only QC released material if within shelf-life Dispensing designated persons written procedure Correct materials accurately weighed clean, properly labelled containers Independent checks and record material and weight or volume Dispensed material kept together and labelled 14.15 – 14.18 Module 11 | Slide 10 of 25 January 2006 Basic Principles of GMP Module 11 | Slide 11 of 25 January 2006 Materials Packaging materials - I Primary and printed packaging materials purchasing, handling and control – as for starting materials Printed packaging materials: particular attention Stored in secure conditions with authorized access Roll labels where possible in place of cut labels Loose materials stored and transported in separate, closed containers - to avoid mix-ups Issued by designated personnel 14.25–14.20 SOP for issue and returns Module 11 | Slide 12 of 25 January 2006 Basic Principles of GMP Module 11 | Slide 13 of 25 January 2006 Materials Printed and primary packaging materials - II Each delivery or batch: specific reference number or identification mark Delivery to packaging department Check quantity, identity and conformity to packaging instructions Outdated or obsolete material Destroyed Disposal record 14.21 – 14.23 Module 11 | Slide 14 of 25 January 2006 Basic Principles of GMP Intermediate and bulk products Kept under appropriate conditions If purchased as such Handled on receipt as though these are starting materials 14.24 – 14.25 Module 11 | Slide 15 of 25 January 2006 Basic Principles of GMP Finished products Held in quarantine until their final release Then stored as usable stock under suitable storage conditions Evaluation and documentation necessary for release Product release procedure Batch record review and related procedure Module 11 | Slide 16 of 25 January 2006 14.26 – 14.27 Materials Rejected, reworked and recovered materials Rejected materials and products Clearly marked Stored separately in restricted areas Action – returned to supplier/destroyed, etc. in timely manner Action approved by authorized personnel – records maintained 14.28 Module 11 | Slide 17 of 25 January 2006 Materials Rejected, reworked and recovered materials Rework and recovery Should be exceptional cases 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 additional testing to be considered by QC Module 11 | Slide 18 of 25 January 2006 Materials Recalled products and returned goods Recalled products Identified Stored separately Secure area - access controlled Decision taken on their fate Returned goods Destroyed unless suitable quality 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 Action taken to be recorded Module 11 | Slide 19 of 25 January 2006 Materials Reagents and culture media Records for receipt or preparation Reagents Preparation in accordance with SOP Appropriately labelled: – concentration, standardization factor, shelf-life, date that restandardization is due, storage conditions – signed and dated Culture media positive and negative controls each time prepared and used Inoculum size appropriate 14.34 – 14.36 Module 11 | Slide 20 of 25 January 2006 Materials Reference standards - I Official reference standards Use preferable whenever these exist Only for the purpose as per monograph Storage conditions Reference standards prepared by the producer Tested, released and stored in the same way as official standards In a secure area A responsible person Secondary or working standards 14.37 – 14.40, 14.42 Appropriate checks and tests at regular intervals Standardized against official reference standards – initially and at regular intervals Module 11 | Slide 21 of 25 January 2006 Materials Reference standards - II Reference standards labelled with information including Name Batch, lot or control number Date of preparation Shelf-life Potency Storage conditions Stored and used in an appropriate manner 14.41, 14.43 Module 11 | Slide 22 of 25 January 2006 Materials Waste materials Waste materials proper and safe storage when awaiting disposal toxic substances and flammable materials: – in suitably designed, separate, enclosed areas as per national legislation 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 | Slide 23 of 25 January 2006 Materials Miscellaneous materials Miscellaneous Rodenticides, insecticides, fumigating agents Sanitizing material No contamination risk to equipment, starting materials, packaging materials, in-process materials, finished products 14.45 Module 11 | Slide 24 of 25 January 2006 Materials Group session List specific aspects of GMP requirements, in relation to the groups of materials listed below, that you would assess when inspecting a manufacturer Printed packaging materials Thermolabile materials Water Sterile materials Identify three materials that present problems in your experience What are some of the problems that you have experienced before and during inspection of materials? Module 11 | Slide 25 of 25 January 2006