DOCUMENT & DATA CONTROL SYSTEM

1. DOCUMENT & DATA CONTROL SYSTEM Presentation by Asad-uz-zamam, Deputy Plant managerWilshire Labs. (Pvt) LTD.Quad-E- Azam Industrial Estate, Lahore

2. DOCUMENT & DATA CONTROL SYSTEM DOCUMENTATION & RECORDs (PART I) Approved & Controlled Document - We should Follow & write what we did - We should not deviate from what is written in Document. Description of the Document - Specifications and procedures for all materials and methods of manufacture and control. - Ensures all personnel know what to do and when to do it. - Ensure that authorized persons have all information necessary for release of product.

3. DOCUMENT & DATA CONTROL SYSTEM • Good documentation • It is an essential part of the quality assurance system and, as such • should exist for all aspects of GMP. ISO GMP Guide lines WHO GMP Guide lines US-FDA Guide lines ICH Guide lines UK GMP Guide lines MCC GMP Guide lines, • South Africa TGA GMP Guide lines, Japanese GMP • Australia

4. DOCUMENT & DATA CONTROL SYSTEM • Benefit of the Documentation system • -Regular review of documents. • Ensures Up to date documents (current) • Amended Documents are available. • - Superseded documents removed properly and not used. • - Properly Distribution & Retrieval of Documents.

5. DOCUMENT & DATA CONTROL SYSTEM • Why are documents so important? • - Communication • It’s a means of Communication. • - Cost Due to availability of documents like Sops/Specification that does not allow to raise CA/PAs so no there is additional cost . • - Audit /Inspections Due to availability of documents, it helps in conducting Audit/inspection in a better.

6. DOCUMENT & DATA CONTROL SYSTEM • The Contents of Documents • Documents should have unambiguous contents. • The title, nature, purpose, Responsibilities, Procedure should be clearly stated.

7. DOCUMENT &DATA CONTROL SYSTEM -They should be laid out in an orderly fashion and be easy to check. - Documents should be clear and legible.

8. DOCUMENT & DATA CONTROL SYSTEM • Finished Products • All finished Products should be identified by labeling, as required by the national legislation, bearing at least the following information:- The name of the Product- A list of the active ingredient(s) showing the amount of each present and a statement of the net contents (e.g. number of dosage units, weight, volume)- The batch number assigned- The Mfg. Date-The expiry Date

9. DOCUMENT & DATA CONTROL SYSTEM • Reference standards • The label and/or accompanying documentshould indicate • -Potency or concentration, • -Date of manufacturing, • -Expiry date, • -Date of the closure after it is first opened, • - Storage conditions etc.

10. DOCUMENT & DATA CONTROL SYSTEM • Specifications and testing procedures -Testing procedures described in documents should be validated in the context of available facilities and equipment before they are adopted.-There should be appropriately authorized and dated specification, including tests on identity, content, purity and quality, for starting and packaging materials, In-Process Products and for finished products.

11. DOCUMENT & DATA CONTROL SYSTEM Labels • Labels are used for containers, equipment or premises should be clear, unambiguous and in the company’s agreed format. • It is often helpful in addition to the wording on the labels to use color to indicate status (e.g. quarantined, accepted, rejected, clean).

12. Document & Data Control System Labels What must be labelled? - Containers, equipment, premises Label information? - Clear, unambiguous, - Colours can be used, e.g. green (accepted), red (rejected)

13. DOCUMENT & DATA CONTROL SYSTEM Labels Different types of labels, e.g. cleaning status, production stage, status of materials, Recoverable Materials. To be Cleaned etc

14. Document & Data Control System Labels can indicate the status of materials such as "quarantine”, “Rejected”, “Approved” “Out Of Specification” etc.

15. Document & Data Control System Finished Product Label That includes: - Name - Active ingredients and their amounts - Batch number - Expiry date - Storage conditions, precautions if necessary - Directions for use, - Name and address of manufacturer

16. Document & Data Control System Specifications and Test Procedures Specifications: - Periodic review. - Compliance with current pharmacopoeia & reference standards available. Test Procedures: - Validated (facility and equipment) before routinely used

17. Document & Data Control SYSTEM Specifications: Starting and packaging materials Include: - Name and internal code - Pharmacopoeia (if applicable) - Qualitative and quantitative requirements and limits Other data may include: - Supplier - Sampling procedure or reference - Storage conditions, precautions - Retest date

18. Document & Data Control SYSTEM Sampling of Starting Materials • What types of documents are associated with sampling of starting materials? - “Sampling Procedure” - “Request for sampling” - “Sampling Form with description of samples”. - “Sampled” slip - “ Approved” or “Rejected” slip

19. Document & Data Control System Master Formula Master formula for each product and batch size • Manufacturing instructions (SMP) that includes: • Name of product with product reference code • Dosage form, strength and batch size • List of starting materials including quantities and unique reference code • Expected final yield with acceptable limits • Processing location and principal equipment

20. Document & Data Control System Standard Manufacturing Procedure • Manufacturing instructions • Equipment preparation (e.g. cleaning, assembling, calibrating, etc.) - Detailed stepwise processing instructions and checks, sequence of additions, times, temperatures, etc. - In-process control instructions and their limits - Storage requirements and special precautions

21. Document& Data Control System Batch Manufacturing Records • - Name of the product, batch number • - Dates and times (e.g. start, major steps, completion) • - 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

22. DOCUMENT &DATA CONTROL SYSTEM • Batch Manufacturing Record • - Record kept for each batch processed based on the master or specifications (e.g. copied to avoid errors) • Check suitability of area and Equipment, clear of previous products, documents, materials. • - Checks recorded

23. DOCUMENT & DATA CONTROL SYSTEM Batch Manufacturing Records • - Main processing steps and key equipment • - In-process controls carried out, person's initials, and results obtained • - Yield at each stage with comments on deviations • - Expected final yield with acceptable limits • - Comments on any deviations from process • - Reconciliation of the Product • - Area clearance check, instructions to operators • - Record of activities

24. Document & Data Control System Master Formulae (Packing Material) • Authorized packing instructions for each product, pack size and type, and to include: -Name of the product -Dosage form, strength and method of application -Pack size (number, weight or volume of product in final container) -List of all packaging materials (quantities, size, types and code number)

25. Document & Data Control System Packing instructions -Special precautions, including area clearance checks (before and after operations). -Description of the packaging operation including equipment to be used. -In-process controls, with sampling instructions and acceptance limits.

26. Document & Data Control System Batch Packaging Records For every batch or part of a batch • Before start – checks that equipment and work station suitable and clean, no previous product • Get “Line clearance Certificate” as per Sop.

27. Document & Data Control System Batch Packaging Records • Name of the product, batch number and quantity to be packed • Batch number, theoretical quantity and actual quantity of finished product • Actual quantity obtained • Dates and times of operation • Name of person responsible for packaging, initials of operators carrying out each step • Checks, and in-process results

28. DOCUMENT & DATA CONTROL SYSTEM Batch Packaging Records - Details of packaging operation, including equipment and line used - Returns to store - Specimen of printed packaging materials, with batch coding approval (batch number and expiry date) - Comments on deviations from the process and actions taken and authorization - Reconciliation of packaging materials, including issues, use, returns and destruction

29. Document & Data Control System Standard Operating Procedures (SOP) • What is an SOP ? • Who is responsible for preparing SOPs ? • What is the format for an SOP ? • Which activities require SOPs ? - Where should SOPs be stored ?

30. Document & Data Control System Standard Operating Procedures (Sop Which activities require SOPs? Equipment and analytical apparatus: -Assembly - Validation - Calibration - Internal labelling, - Quarantine - Storage of materials - Maintenance/Cleaning - Self Inspection Personnel Matters • Job Description with Qualification • - • Training • Clothing - Hygiene

31. Document & Data Control System Standard Operating Procedures - Environmental monitoring - Customers Complaints • Product Recalls from the Distributor/Market - Rejected & Returned goods

32. Document & Data Control System Standard Operating Procedures • SOP and records for receiving materials -Name of material as on delivery note. -Name and in-house code. -Date of receipt. -Supplier's and manufacturer's name. -Batch number. -Quantity and number of containers received. -Status of container and other information.

33. DOCUMENT & DATA CONTROL SYSTEM • Standard Operating Procedures • Batch release or rejection • Equipment assembly and validation • Maintenance, cleaning and sanitation

34. Part ( I ) of this Presentation is closed