Documentation –Part 2 Basic Principles of GMP Pharmaceutical Quality, Good manufacturing Practice & Bioequivalence Kiev, Ukraine 3 - 7 October 2005 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 E-mail: hietavam@who.int Part One, 15

Documentation Labels What must be labelled? What must be on the label? 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

Documentation

Specifications and Test Procedures 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

Documentation

Documentation- batch record Easy reading Well designed by careful setting of blocks Systematic approach of information

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, 15.22–15.24

Documentation Master Formulae II Equipment preparation methodology 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

Documentation Master Formulae III Name of the product 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

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

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Batch Processing Records - I 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

Batch Processing Records - II 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

Batch Packaging Records - III 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

Batch Packaging Records - IV 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 Record of activities and check signatures Part One, 15.28–15.30

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Standard Operating Procedures - I 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

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 Part One, 15.31–15.48

Standard Operating Procedures - III 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

Stock Control and Distribution Records 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 Part One, 15. 1–15.9

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