1. WHO - PSM Documentation – Part 2 Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 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 Basic Principles of GMP Part One, 15

2. WHO - PSM Documentation Question no 7 l What would provide you substantial information at glance?

3. WHO - PSM Part One, 15.10–15.12 Documentation Labels l What must be labelled? ä Containers, equipment, premises, products, intermediates, samples, standards etc. ä Status (quarantined, accepted, rejected, clean) l What must be on the label? ä Company internal system ä Final products: national or multinational system l Who has responsibility for labelling? ä QC and production for status labels ä Final product, intermediates, reagents etc.

4. WHO - PSM Documentation

5. WHO - PSM Part One, 15.13–15.21 Documentation Specifications and Test Procedures l Starting and packaging materials l Intermediates and bulk products l Finished products l Specifications: approved and dated by authorised persons l Test procedures: validated or verified for reliability and consistency

6. WHO - PSM Documentation

7. WHO - PSM Documentation- batch record l Easy reading l Well designed by careful setting of blocks l Systematic approach of information

8. WHO - PSM Part One, 15.22–15.25 Documentation Master Formulae I l Manufacturing instructions ä Name of product with product reference code ä Dosage form, strength and batch size ä Full list of materials including quantities; unique reference code ä Expected final yield with acceptable limits (+intermediate yields) ä Processing location and principle equipment

9. WHO - PSM Part One, 15.22–15.24 Documentation Master Formulae II l Manufacturing instructions - continued ä Equipment preparation methodology ä Stepwise processing instructions ä Details of in-process controls with instructions for sampling and acceptance limits ä Storage requirements and special precautions.

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

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

12. WHO - PSM Documentation

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

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

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

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

17. WHO - PSM Documentation

18. WHO - PSM Documentation Standard Operating Procedures - I l Who is responsible for SOPs? ä Writer, supervisor, manager, QA ä Writing, checking, approval l Where should SOPs be stored? ä Master copies – responsible department ä Authorised copies: working place ä Non-valid copies and non-valid master copies ; where Part One, 15.31–15.48

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

20. WHO - PSM Documentation Standard Operating Procedures - III l Which activities require SOPs? - continued ä Batch release or rejection. ä Maintenance of distribution records ä Equipment assembly and validation ä Calibration and operation of analytical apparatus ä Maintenance, cleaning and sanitation ä Personnel recruitment, training, clothing and hygiene ä Environmental monitoring Part One, 15.31–15.48

21. WHO - PSM Documentation Question no 8 l What do the letters SOP mean?

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

23. WHO - PSM Documentation Question no 9 l What is the situation when documentation is needed very very very much. And information has to be found in the documents very quickly to take actions as rapidly as possible.

24. WHO - PSM Documentation Water Quality Manual l Full details of design of system, operation and maintenance ä Supplier manuals can be used with internal procedures l Details of testing requirements ä Microbiological ä Chemical

25. WHO - PSM Documentation Conclusion l If there is no documentation, there work has not been carried out!!! l Everything has to be documented, right?