Documentation in pharmaceutical industry

documentation

1. DOCUMENTATION IN PHARMACEUTICAL INDUSTRY PREPARED BY: DEVIPRIYA P V M PHARM 2017 DEPT OF PHARMACEUTICAL ANALYSIS

2. DOCUMENTATION Document is any written statement or proof. An essential part of quality assurance. Defines the specification for all materials and methods of manufacture and control. Provides an audit trial. Ensures the authorized person to have all the necessary information. 2

3. OBJECTIVES Define the manufacturers system of information and control. To minimize the risk of misinterpretation inherent in oral communication. To follow uniform procedures. To allow tracing of batch history. 3

4. AIM To define the specifications for all materials. To define methods to manufacture and control. To ensure that all personnel connected with manufacture and control know what to do & when to do. To ensure that all personnel authorized to release a batch for sale or reject it have all the information that is necessary to take the decision. 4

5. To provide information during investigation , if a batch is suspected to have defects. To make available data for validation , review and statistical analysis. 5

6. Revised M schedule has the following elements which are related to documentation: Specifications and Standards. Master Formulae Records. Batch Production and Control Records (BPCR). Batch Packaging Records (BPR). Calibration and Validation records. Quality control records. Distribution records. 6

7. STANDARD OPERATING PROCEDURES “SOP is a set of instructions complied by an organization to help workers to carry out the complex routine operation”. 7

8. AIM Create the culture where quality objective are transparent and well understand. They form the backbone of the pharmaceutical. To achieve efficiency. To achieve quality output. To achieve uniformity of performance. To achieve uniformity of quality. 8

9. SOP writing style SOPs shall be written in concise, step by step, easy to read and follow format. Information should not be complicated. Should be simple and short. Routine procedures that are short and require few decisions can be written using simple step format. 9

10. Cont….. Long procedures with more than 10 steps, with few decisions should be written along with graphical format or hierarchical steps. Procedure that require many decisions should be written along with flow chart. Include the requirements for document identification and control, accountability and traceability, responsibility. 10

11. While writing SOP Write in present tense. Avoid ambiguity. Be concise. Keep the words short and get to point. Move from one step to another in logical manner. Highlight exception. Highlight warning. Reduce the word count where possible without altering the meaning of the text. Introduce acronyms without explaining what it means. 11

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13. General format for SOP SOP number: Title: Department: Date: Revision number: Effective date: 13

14. MASTER FORMULA RECORD “Written procedures that give the complete description of all aspects of its manufacture, packing and control with an intention to ensure the purity , identity, quality and strength of each dosage unit throughout its shelf life” 14

15. Cont… Prepared by research and development team. Include all information about the manufacturing process for the product. Used as a reference standard for preparing Batch Manufacturing Records (BMR) by manufacturing units. Also called Master Manufacturing Record, Master Production Record. 15

16. It includes the following information: Specifying a fixed formulation. Identifying quality criteria for components. Providing a set of manufacturing instructions. Describing systematic sampling procedure. Using precise assays, tests etc. Establishing methods for ensuring complete accountability for all materials including packing and labeling. 16

17. Include: Product details Flow chart. Equipment. Special instructions. Calculations. Manufacturing process. Packaging process. Yield. 17

18. Master formula record 18

19. Steps to prepare MFR Production department in association with R&D, shall prepare MFR. Prepare as per the format associated with SOP. Divided into two parts: Packaging part. Manufacturing part. 19

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22. BATCH FORMULA RECORD BPR is a documentation which shows that significant manufacturing processes and in-process controls were accomplished in accordance with master formulation record for that product Required to be maintained for each batch of the product manufactured . Product and batch specific document which gives an entire picture of manufacturing history of each batch of every product. 22

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24. It include: Name of the product Trade name Specification of raw material. Name of raw material. Specification of container, closure and packing material. Name of item. Weighment sheet. Dispensing instructions. 24

25. Cont…. List of equipment and machinery. Dispensing instructions. Packaging requirements. Packaging instructions. Precautions to be taken. Finished product specifications. Expiry date. Review due on . 25

26. BFR should have following columns: Serial number. Name of ingredients. Reference of specifications of ingredients. Quantity to be added. Overages to be added. Quantity added per batch or per lot. Below that give the calculation step for every active ingredient, ensuring that the active material shall be compensated for assay values less than 100% which could be due to less potency or higher moisture content. 26

27. Batch formula record 27

28. QUALITY AUDIT “A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements, and whether these arrangements are implemented effectively and are suitable to achieve objectives”. 28

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30. Basic types Imposed upon manufacturer or supplier Regulatory Customer or potential customer. Third party( on behalf of customer) Performed by manufacturer: Internal External 30

31. THREE TIER APPROACH Internal audits are carried out by organization of its own system, procedures and facilities. Internal audits are required for business prospective. One possible system for internal audit is three tier approach. Carried out by corporate compliance group. External consulters may be used. 31

32. Cont…. To assess the readiness for regulatory audit. To have an expert view on specific critical activity. Three tier auditors are highly trained, experienced or specialist with an expert knowledge of GMP and other regulatory requirements for pharmaceuticals. 32

33. AUDIT PLAN Required for effective audit at low cost. A comprehensive list of the specific audit procedures that the audit team needs to perform to gather sufficient appropriate evidence on which to base their opinion on the financial statements. Audit planning is carried out before start of audit. 33

34. When planning the engagement, the auditor needs to develop and document a plan that describes the procedures to be performed to assess the risk of material misstatement at the financial statement and assertion level. The auditor must then carefully plan the nature, timing and extent of control tests and substantive tests that are designed to mitigate these risks to an acceptable level. 34

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36. Audit Documentation Written record of the basis for the auditor’s conclusion that provides the support for the auditor’s representations, whether those representations are contained in the auditor’s report or otherwise. It includes records of the planning and performance of the work, the procedures performed, evidence obtained 36

37. AUDIT REPORT Financial records and accounts of the company. The audit reporting is the communication of audit conclusions after having carried out the audit process in accordance with the audit plan. Signed written document which presents the purpose, scope and results of the audit. 37

38. The content of audit report Whether the financial information disclosed in the financial statements has been prepared using acceptable accounting policies. Whether the said policies are consistently applied year after year. Whether the financial information complies with the relevant regulations and statutory requirements. 38

39. Basic elements Title . Addressee. Opening or introductory paragraph. Identification of financial statement audited. A statement on the responsibility of the entity’s management and that of auditor. Scope paragraph. A reference to the auditing and standards generally accepted in India. A description of work performed by the auditor. 39

40. Opinion paragraph A reference to the financial reporting framework used to prepare the financial statement. Expression of opinion on the financial statement. Date of the report. Place of signature. Auditor’s signature. 40

41. SPECIFICATIONS Authorized and dated specifications for starting materials, packaging materials, finished products, intermediates and bulk products. Approved and maintained by the QC department. Periodic review is necessary. In India, D&C act requires the drugs to comply with standards as laid down in the 2 nd schedule. 41

42. TESTING PROCEDURES After having prepared the specifications for materials and finished products , QC department should prepare test procedures for testing materials. The items which are official in any pharmacopoeia or any other recognized book of standards can be tested as per test procedures. Methods should give accurate results. These should be validated before adopting for routine testing. 42

43. DISTRIBUTION RECORDS Written data related to distribution of drug products from the manufacturer to the distributors. Purpose is to ensure that adequate data is available to access trade A distribution register should be maintained for detailed information about distribution of each batch of drug product. 43

44. Cont…. Contain name and strength of the product , description of the dosage form, name and address of the consignee, data quantity shipped, lot or control number of the drug product. Include invoices, bill of lading, customer receipts, internal warehouse storage and inventory records. An inventory card is maintained to find out the stock position quickly. 44

45. THANK YOU 45