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Basic Principles of GMP. Materials. 14. 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

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materials
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
materials3
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

14.1, 14.2

materials4
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

14.3–14.6

materials5
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

materials6
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

14.11 – 14.14

basic principles of gmp8
Basic Principles of GMP
  • Damage to and problems with containers
    • Recorded and reported to QC
    • Investigated
materials9
Materials

Examples of Labelling of Starting Materials

materials10
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

materials12
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
    • SOP for issue and returns

14.25–14.20

materials14
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

basic principles of gmp15
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

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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

14.26 – 14.27

materials17
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

materials18
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
      • New batch number
    • additional testing to be considered by QC

14.29 – 14.30

materials19
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
    • Action taken to be recorded

14.32 – 14.33

materials20
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

materials21
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
    • Appropriate checks and tests at regular intervals
    • Standardized against official reference standards – initially and at regular intervals

14.37 – 14.40, 14.42

materials22
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

materials23
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

materials24
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

materials25
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?