1. Module 12 - part 2Slide 1 of 23 WHO - EDM Basic Principles of GMP Documentation Part 2 Part One, 14

2. Module 12 - part 2Slide 2 of 23 WHO - EDM Documentation Group Session I

3. Module 12 - part 2Slide 3 of 23 WHO - EDM Documentation

4. Module 12 - part 2Slide 4 of 23 WHO - EDM Part One, 14.10–14.12 Documentation Labels l What must be labelled? l What must be on the label? l Who has responsibility for labelling?

5. Module 12 - part 2Slide 5 of 23 WHO - EDM Documentation

6. Module 12 - part 2Slide 6 of 23 WHO - EDM Part One, 14.13–14.21 Documentation Specifications and Test Procedures l Starting and packaging materials l Intermediates and bulk products l Finished products

7. Module 12 - part 2Slide 7 of 23 WHO - EDM Documentation

8. Module 12 - part 2Slide 8 of 23 WHO - EDM Part One, 14.22–14.25 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. Module 12 - part 2Slide 9 of 23 WHO - EDM Part One, 14.22–14.25 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. Module 12 - part 2Slide 10 of 23 WHO - EDM Part One, 14.22–14.25 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. Module 12 - part 2Slide 11 of 23 WHO - EDM Part One, 14.22–14.25 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. Module 12 - part 2Slide 12 of 23 WHO - EDM Documentation

13. Module 12 - part 2Slide 13 of 23 WHO - EDM Part One, 14.26–14.28 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. Module 12 - part 2Slide 14 of 23 WHO - EDM Part One, 14.26–14.28 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. Module 12 - part 2Slide 15 of 23 WHO - EDM Part One, 14.29–14.31 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. Module 12 - part 2Slide 16 of 23 WHO - EDM Part One, 14.29–14.31 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. Module 12 - part 2Slide 17 of 23 WHO - EDM Documentation

18. Module 12 - part 2Slide 18 of 23 WHO - EDM Documentation Standard Operating Procedures - I l Who is responsible for SOPs? l Where should SOPs be stored? Part One, 14.32–14.49

19. Module 12 - part 2Slide 19 of 23 WHO - EDM Documentation 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. Module 12 - part 2Slide 20 of 23 WHO - EDM 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, 14.32–14.49

21. Module 12 - part 2Slide 21 of 23 WHO - EDM Documentation Stock Control and Distribution Records l What should be recorded? l Where should records be stored? l Why are the records important?

22. Module 12 - part 2Slide 22 of 23 WHO - EDM Documentation Water Quality Manual l Full details of design of system, operation and maintenance l Details of testing requirements