Good documentation practice
- 3. CONTENTS • DEFINITIONS • ALCOA (+) PLUS • PRINCIPLE OF GOOD DOCUMENTATION • TYPES OF GMP DOCUMENTS • LABORATORY RECORDS • EQUIPMENT RELATED DOCUMENTATION • DEVIATION AND INVESTIGATIONS • BATCH RECORDS • CERTIFICATE OF ANALYSIS • STANDRD OPERATING PROCEDURE • PROTOCOLS AND RECORDS • TRIANING DOCUMNTATION • RETENTION TIME OF DOCUMENTS • PROCEDURE OF DOCUMENTATION • DO’S & DON’T’S
- 4. DOCUMENTATION: Documentation is a set of documents that provides official information or evidence or serves as a record. GOOD DOCUMENTATION PRACTICE : Methods for recording ,correcting and managing data, documents and records, to ensure the reliability and integrity. DATA INTEGRITY : Data integrity is the degree to which a collection of data is complete, consistent, accurate throughout the data life cycle. META DATA: Data that provides information about other data AUDIT TRAIL: Information associated with actions that related to the creation, modification or deletion of records. DEFINITIONS:
- 6. A Commenly used acronym for “ Attributable, Legible, Contemporaneous, Original and Accurate”. ATTRIBUTABLE: Who acquired the data or performed an action and when? LEGIBLE : Readable and understandable by all users of document. CONTEMPORANEOUS: Data must be document at the time of activity ORIGINAL: Data should be original or true copy ACCURATE: Data are correct, truthful, complete, valid and reliable. ALCOA
- 7. ALCOA expanded to ALCOA PLUS COMPLETE: All the data including the repeat analysis. No deletion. CONSISTENT: Consistent generation of records and the time stamps ENDURING: Data recorded in controlled work sheets or validated systems. AVAILABLE: Data available for review, audit, inspection for the life of the record. ALCOA PLUS
- 8. PRINCIPLES OF GOOD DOCUMENTATION • Clear and legible records. • Data entry should be recorded at the time of activity. • Backdating and postdating are not allowed. • Corrections to entries should be dated and signed. • Data entry should be traceable to the person who made the entry. • Uncommon abbreviation and acronym should be defined. • Control should be place to protect the integrity of the record.
- 9. PRINCIPLES OF GOOD DOCUMENTATION • Printouts taken on the thermal paper or easily fading inks should be photocopied. • Notebooks, Data sheets and Worksheets should be traceable. • Documentation system is needed to ensure the data integrity and availability of records. • During the retention period, the records should be readily available. • All pages should be paginated. Attachments to be paginated with a reference to parent document.
- 10. TYPES OF GMP DOCUMENTS LABORATORY RECORDS EQUIPMENT RELATED DOCUMENTATION DEVIATION AND INVESTIGATIONS BATCH RECORDS CERTIFICATE OF ANALYSIS STANDARD OPERATING PROCEDURES PROTOCOLS AND REPORTS ANALYTICAL PROCEDURES TRAINING DOCUMENTATION
- 11. LABORATORY RECORDS Laboratory records should be organized to ensure that the records are concise ,clear, legible and accurate and detail the following: • Description of Materials(E.g. Reagents) • Identification of equipment used • Procedures Used • Measurements • Formulae and Calculations • Results and Conclusions.
- 12. EQUIPMENT RELATED DOCUMENTATION All equipment used in laboratory should be maintained, qualified and documented • Policies and procedures for operation and maintenance • Equipment use • Maintenance records • Calibration or qualification records • Instrument labeling
- 13. DEVIATION AND INVESTIGATIONS All aberrations, anomalies and exceptions should be documented. • Description of the event • Root cause investigation • Evaluation of data trend • Responsibilities of people involved in the deviation/investigations • Impact assessment • Corrective action and preventive action(CAPA) with timelines • Review and approval
- 14. BATCH RECORDS A Master Batch Record (MBR) created as a template for the manufacture of specific product. • Header information (E.g. product name, batch number, Manufacturing site) • Unit of operation (E.g. blending, coating, milling) • Manufacturing process • Target weights (raw materials) • Conditions (time, temperature) • Deviations and investigations • In-process sampling or testing • Other critical information, as applicable • Sampling plan for release, stability, and retention • Review and approval
- 15. CERTIFICATE OF ANALYSIS Report of analytical results. • Vendor, supplier, or manufacturer information (as applicable) • Product information (name and strength) • Results for the specific batch, with name of test, acceptance criteria, and result for each test • Conformance statement or equivalent • Reference to procedure and specification document • Reference of data source • Approval and date • Expiration date or retest information
- 16. STANDRAD OPERATING PROCEDURE Provide directions to trained personnel regarding a given set of activities. • Purpose and scope • Instructions and procedure • Responsibilities and roles • Materials or equipment, as appropriate • Definitions or references, as needed • Review and approval • Revision history
- 17. PROTOCOLS AND REPORTS Activities and tasks executed on the basis of predefined, preapproved protocols. • Equipment qualification • Analytical method validation or verification • Manufacturing process validation • Analytical method or manufacturing technology transfer • Cleaning validation • Stability study or testing • Comparability study
- 18. PROTOCOLS AND REPORTS Protocols and reports should included following sections. • Purpose • Plan or instructions • Predetermined acceptance criteria • Deviations or investigations, or a reference to (for report only) • Assessment or evaluation (for report only) • Data reference (for report only) • Review and approval • Revision history
- 19. ANALYTICAL PROCEDURES Direction to an operator on how to perform a given analytical Test. • Purpose • Test information • Product information • Safety information, if applicable • Materials and equipment • Procedure, as applicable • System suitability • Preparation of solutions and reagents • Preparation of standards and samples • Instrument parameters • Calculations and reporting • Review and approval with approval dates • Revision history
- 20. TRAINING DOCUMNETATION Training record should be documented, retained and readily available. • Training description including name of training, version, and mode (self-training or instructor led) • Completion date • Information on the trainer, as applicable
- 21. RETENTION OF DOCUMNETS Retention time length of document depends on the regulatory requirements or company procedures. However it should be at least 1 year after the batch expiration date.
- 22. RETENTION TIME OF DOCUMENTS
- 23. DOCUMNETATION PROCEDURE Generation Review & Approval Issuance Record Review & Reconcilia tion Retention Revision Destruction
- 24. GOOD DOCUMENTATION PRACTICE DO’S: • Use pre numbered bounded note book. (Every register form/note shall have header, date of opening, date of closing, Table of content) • Enter complete and accurate information at the time of activity. • Enter signature or Initials (According to procedure) • When more than one person completed the task, all person should be sign. • Use a non water soluble black or blue color ball point pen to make entries. • Corrections to written records must be made properly. • Draw a single line through the incorrect entry. • Write initials and date of correction. • Record the Data clearly. • When Spaces or shell don’t contain information, entry N/A. • Limit the use of abbreviation and acronym. • Second verification is must.
- 25. GOOD DOCUMENTION PRACTICE DONT’S • Don’t do any temporary entries in a bit paper of hand. • Don’t remove any pages from note book. • Don’t enter your performed by sign for the work performed by someone else. • Don’t back date or post date. • Don’t do over write. • Don’t mask the original entry. • Don’t use gel pens and ink pens. • Don’t use red or green color ink pens. • Don’t use correction liquid. • Don’t vary your signature or initial.
- 26. REFERENCE • HTTPS://ONLINE.USPNF.COM/USPNF/DOCUMENT/GUID-5A751AEB-D4F1- 488C-AE4B-018D9D6D698A_3_EN-US • HTTPS://WWW.IPA-INDIA.ORG/STATIC-FILES/PDF/EVENT/IPF2018- PRESENTATION22.PDF • HTTPS://WWW.SLIDESHARE.NET/HARDIK_MISTRY/GOOD- DOCUMENTATION-PRACTICE-14427854 • HTTPS://WWW.SLIDESHARE.NET/DRAMSAVELVEL/GOOD- DOCUMENTATION-PRACTICE-88810012