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					            Basic Principles of GMP

          Documentation –Part 2
               Workshop on
 GMP and Quality Assurance of HIV products

                                   Shanghai, China
                                28 Feb - 4 March 2005
                                                                                 Part One, 15
                                     Maija Hietava
                                       M.Sci.Pharm
Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and
                                    Pharmaceuticals Cluster
                          Tel: +41.22.791.3598 Fax: +41.22.791.4730
                                World Health Organization           WHO - PSM
                              E-mail: hietavam@who.int
                  Documentation
                            Labels
   What must be labelled?
     Containers, equipment, premises, products, intermediates,
      samples, standards etc.
     Status (quarantined, accepted, rejected, clean)
   What must be on the label?
     Company internal system
     Final products: national or multinational system
   Who has responsibility for labelling?
     QC and production for status labels
     Final product, intermediates, reagents etc.
                                                       Part One, 15.10–15.12


                                                    WHO - PSM
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                WHO - PSM
             Documentation
      Specifications and Test Procedures

   Starting and packaging materials
   Intermediates and bulk products
   Finished products
   Specifications: approved and dated by
    authorised persons
   Test procedures: validated or verified for
    reliability and consistency
                                          Part One, 15.13–15.21


                                       WHO - PSM
Documentation




                WHO - PSM
     Documentation- batch record

   Easy reading
   Well designed by careful setting of blocks
   Systematic approach of information




                                            WHO - PSM
                 Documentation
                   Master Formulae I
   Manufacturing instructions
     Name of product with product reference code
     Dosage form, strength and batch size
     Full list of materials including quantities; unique
      reference code
     Expected final yield with acceptable limits
      (+intermediate yields)
     Processing location and principle equipment

                                                 Part One, 15.22–15.25


                                               WHO - PSM
                Documentation
                 Master Formulae II
   Manufacturing instructions - continued
     Equipment preparation methodology
     Stepwise processing instructions
     Details of in-process controls with instructions for
      sampling and acceptance limits
     Storage requirements and special precautions.


                                               Part One, 15.22–15.24


                                             WHO - PSM
                Documentation
                 Master Formulae III
   Packing instructions
     Name of the product
     Dosage form, strength and method of
      administration
     Pack size (number, weight or volume of product in
      finished pack)
     List of all packaging materials (quantities, size and
      code number)
                                            Part One, 15.22–15.24


                                            WHO - PSM
                Documentation
                Master Formulae - IV
   Packing instructions - continued
     Examples of printed packaging materials, with
      location of batching information
     Special precautions, including area clearance
      checks
     Description of the packaging operation
     In-process control checks, with sampling
      instructions and acceptance criteria     Part One, 15.22–15.24




                                              WHO - PSM
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                WHO - PSM
                 Documentation
            Batch Processing Records - I
   Name of the product, batch number
   Dates and times for major steps in process
   Name of person responsible for each stage of
    production
   Name of operators carrying out each step (check
    signatures)
   Theoretical quantities for materials in the batch
   Reference number and quantity of materials used in
    the batch
                                                 Part One, 15.25–15.27


                                             WHO - PSM
               Documentation
           Batch Processing Records - II
   Main processing steps and key equipment
   In-process controls carried out, and results
    obtained
   Yield at each stage with comments on deviations
   Expected final yield with acceptable limits
   Comments on any deviations from process.
   Area clearance check, instructions to operators
   Record of activities
                                           Part One, 15.25–15.27


                                         WHO - PSM
                Documentation
           Batch Packaging Records - III
   Name of the product, batch number and quantity to
    be packed
   Batch number, theoretical quantity and actual
    quantity of finished product
   Reconciliation calculations, dates and times of
    operation
   Name of person responsible for packaging, initials of
    operators carrying out each step
   Checks made and results obtained
                                           Part One, 15.28–15.30


                                            WHO - PSM
                    Documentation
             Batch Packaging Records - IV
   Details of packaging operation, including equipment
    and line used
   Returns to store
   Specimen of printed packaging materials, with batch
    coding
   Comments on deviations from the process and actions
    taken
   Reconciliation of packaging materials, including returns
    and destruction
   Area clearance check
   Product variables                           Part One, 15.28–15.30
   Record of activities and check signatures
                                                 WHO - PSM
Documentation




                WHO - PSM
             Documentation
     Standard Operating Procedures - I
   Who is responsible for SOPs?
       Writer, supervisor, manager, QA
       Writing, checking, approval
   Where should SOPs be stored?
       Master copies – responsible department
       Authorised copies: working place
       Non-valid copies and non-valid master copies ; where

                                            Part One, 15.31–15.48



                                            WHO - PSM
       Standard Operating Procedures - II
   Which activities require SOPs?
     Receipt of all material deliveries
     Internal labelling, quarantine and storage of materials
     Operation, maintenance and cleaning of all instruments and
      equipment
     Sampling of materials
     Batch numbering systems
     Material testing at all stages of production




                                                WHO - PSM
                 Documentation
        Standard Operating Procedures - III
   Which activities require SOPs? - continued
     Batch release or rejection.
     Maintenance of distribution records
     Equipment assembly and validation
     Calibration and operation of analytical apparatus
     Maintenance, cleaning and sanitation
     Personnel recruitment, training,
      clothing and hygiene
     Environmental monitoring


                                                Part One, 15.31–15.48



                                                  WHO - PSM
                 Documentation
     Stock Control and Distribution Records
   What should be recorded?
      Essential information needed for traceability to the
       manufacturer and supplier information of the material and the
       date of arrival  PRODUCT RECALL
      Stock Control: Batch numbers, status, quantities, expiry date
       etc., FIFO, EEFO (earliest to expire, first out)
      Distribution records: batch number, quantity and destination of
       each delivery
      Inventory: validation of the stock records
   Where should records be stored?
      Easily available
   Why are the records important?
      Traceability and status of materials



                                                    WHO - PSM
                 Documentation
                Water Quality Manual


   Full details of design of system, operation and
    maintenance
     Supplier manuals can be used with internal procedures
   Details of testing requirements
     Microbiological
     Chemical




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