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Chapter 4 Documentation (General (Documentation (recorded by electronic…

- - - - description of dosage form, strength of product & batch size
      - list of starting materials used (amount, describe use designated name, reference that unique to material, mention made substance may disappear in course of processing)
      - name & reference code of product
      - statement of expected final yield with acceptable limits, relevant intermediate yields
    - - statement of processing location, principal equipment
      - methods, reference to methods, used for preparing critical equipment (e.g. cleaning, assembling, calibrating)
      - detailed of procedure (e.g. checks on materials, pre-treatments, sequence for adding materials, mixing times, temperatures)
      - instructions for any IPQC with limits
      - requirements for bulk storage of products (container, labelling, special storage conditions where applicable)
      - any special precautions to be observed
    - - exist for product & batch size manufactured
      - combined in one document
    - - drying, crushing, sifting, drying time, temperatures, methods used to control fragment @ particle size
      - security sieving @ other methods of removing foreign materials
    - - ensure that each container carefully examined
      - to detect any adulteration/substitution @ presence of foreign matter
      - metal @ glass pieces, animal parts @ excrement, stones, sand, rot & signs of decay
    - - Details
        
        base @ solvent, time & temperatures of extraction
        
        any concentration stages & methods used
- - - - specifications
      - sampling procedures
      - testing procedures & records
      - worksheets @ laboratory notebooks
      - analytical reports @ certificates
      - data from environmental monitoring
      - procedures for & records of calibration of instruments & maintenance of equipment
    - - retained for one year after expiry date of batch
  - - - Manufactured
        
        GMP & Product Registration dossier
        
        ensure suppliers compliance with acceptable standards
      - Audits
        
        comprehensive documentation
        
        audit trail of API is fundamental to quality of starting material
      - Authorised & date specification
        
        starting materials
        
        packaging materials
        
        finished products
        
        intermediate products
        
        bulk products
    - - Details
        
        scientific @ botanical name for plant; if possible with reference of authors
        
        details source of plant (country @ region of origin, where applicable, cultivation, time of harvesting, collection procedures, possible pesticides used)
        
        whether whole plant/animal @ only part used
        
        when dried plant/animal purchased, drying system be specified
        
        description of plant material, macroscopical @ microscopical visual inspection
      - Tests
        
        identification tests
        
        assay test
        
        limit tests
        
        determination of pesticide contamination & limits accepted
        
        tests for toxic metals, contaminants, foreign materials & adulterants
        
        tests for radioactivity, aflatoxin & microbial contamination
        
        any treatment used to reduce fungal/microbial contamination @ other infestation
    - - Description
        
        designated name & internal code reference
        
        reference, pharmacopoeia monograph
        
        approve supplier, original producer of products
        
        specimen of printed materials
      - directions for sampling & testing @ reference to procedures
      - qualitative & quantitative requirements with acceptance limits
      - storage conditions & precautions
      - maximum period of storage before re-examination
    - - be available if purchase @ dispatch
      - data obtained from intermediate products used for evaluation of finished product
      - similar to specifications for starting materials @ finished products
    - - Tests
        
        microbial & toxic metals contamination
        
        uniformity of weight (tablets, capsules), disintegration (tablets, capsules, pills), hardness & friability (tablets), viscosity (internal & external fluids)
        
        physical appearance (colour, taste, size)
      - Details
        
        designated name of product & code reference
        
        formula @ reference
        
        description of dosage form & package details
        
        directions for sampling, testing @ reference to procedure
        
        qualitative & quantitative requirements, with acceptance limits
        
        storage condition, any special handling precautions, where applicable
        
        shelf-life
- - - - at time each action taken
      - after completion
      - dated & signed in agreement by person responsible
    - - batch number, analytical control number, quantities of each starting material actually weighed (batch number, amount of any recovered @ reprocessed materials added)
      - any relevant processing operation @ event & major equipment used
      - initials of operator of different significant steps of production, person who checked each of operations (e.g. weighing)
      - record of IPQC initials person carry them out, results obtained
      - name of person responsible for each stage
      - product yield obtained at different & pertinent stages of manufacture
      - dates & times, significant intermediate stages & completion of production
      - notes on special problems (details, signed authorisation for any deviation from Manufacturing Formula & Processing Instructions)
      - name of product
- - - - at time each action taken
      - after completion
      - dated & signed in agreement by person responsible
    - - records of checks for identity & conformity with packaging instructions, results of IPQC
      - details (references to equipment & packaging lines used) of carry out operations
      - initials of operator of different significant steps
      - samples of printed packaging materials used, specimens of batch coding, expiry date & any additional over-printing
      - name of responsible persons carry out
      - notes on special problems, unusual events (details, signed authorisation Manufacturing Formula, Processing Instructions)
      - dates & times of packaging operations
      - quantities, reference number, identification of printed packaging materials & bulk product issued, used, destroyed or returned to stock, quantities of obtained product, provide for adequate reconciliation
      - name of product
- - - - receipt of each delivery
      - starting & primary printed packaging material
      - written procedures & records
    - - name of material on delivery note, containers
      - “ in-house” name @ code of material (if different from first)
      - date of receipt
      - supplier’s name & manufacturer’s name
      - manufacturer’s batch @ reference number
      - total quantity, number of containers received
      - batch number assigned after receipt
      - any relevant comment (e.g. state of the containers )
  - - - specify person authorised to take samples, sampling instructions
    - - batch (lot) numbering system
      - objective ensure each batch of intermediate, bulk, finished product
      - identify with specific batch number
    - - placed in close proximity
    - - same batch numbers not repeatedly use, applies also to reprocessing
      - applied to processing stage & respective packaging stage related to each other
  - - - calibrations, maintenance, cleaning, repair operations
      - include dates, identity of people that carry out
      - kept with major, critical equipment & record
    - - chronological order use of major @ critical equipment & area where products process