HYGIA-INSPIRING TRAINING & EARNING [HITE] Module: General Training DOCUMENTATION: LABORATORY IN A PHARMACY INSTITUTION Dr. Bharat Mishra, Professor, Dept. of Pharmacology & Director, Research & Development Hygia Group of Institutions Objectives ● To understand the type of documents required in a typical laboratory. ● To understand the common documents required in a pharmacy laboratory. ● To understand and comply the regulatory requirements for documentation. ● To understand the self explanatory and standard format of documents required in a pharmacy laboratory. ● To be enabled to develop and maintain the standard lab documents. Trainees will be enabled after the training: To create the standard documents required in a pharmacy laboratory Type of Documents 1. Personal Roles and responsibilities of the Lab technicians, general instructions, technician’s profile, instrument handling manuals, course practical books, practical manual, PCI requirement list, AKTU requirement list, time tables, total instrument cost, contact details of the engineers of various companies, institutional ARC guidelines for the labs and practical conduction etc. 2. Work Assignment: Syllabus, AKTU and PCI guidelines, Time schedule, defined process of lab and experiment planning, availability of material for that planning, policies and guidelines for conducting the experiments. 3. Log Records Record of planning of experiments, usage records for the consumables and non- consumables, instrument usage, instrument repair schedule and record, instrument calibration record, purchase indent record, receiving of goods record. 4. Informative: Bibliographic styles for the lab, instructions for the student, list of reference books, websites, tutorials etc. for the students and lab technicians, manual for the glassware and chemical storage, SOPs for the machine and processes, guidelines for the chemical storage methods and rack arrangements. Guidelines for the glassware cleaning and general maintenance of the instruments, safety manual for the lab and the laboratory users, guidelines for the standard treatment of expired chemicals etc. PCI and AKTU guidelines for the chemical storage and lab infrastructure, exam guidelines for the external and internal practical. 5. Holding and distribution Stock register for the chemical and glassware with the date of receiving, person responsible for receiving, and chemical usage register with the same particulars. Distribution of lab chemicals record. List of the documents in the lab, utilization record for the issued material to the lab other than chemicals. 6. Laboratory control Cleaning schedule, duty chart for the technician and attendance, responsibilities and hierarchies, confidentiality, exam related authorities and controls, student control etc. Principal record of the laboratory: 1. 2. 3. 4. 5. 6. 7. 8. PLANNING REGISTER ISSUE REGISTER STOCK REGISTER BREAKAGE REGISTER MAINTENANCE/REPAIR REGISTER CALIBRATION REGISTER LOG BOOK REGISTER LIST OF CHEMICALS AND GLASSWARES 9. FILE FOR THE XEROX OF THE ORDER FORM/INDENT FORMS. 10. PROCEDURES FILE/LAB MANUAL Action Plan for the documentation for the trainees: Step 1 After receiving a well discussed training and the training document use your notes to understand the structure, flow and sequence of information in the document. Step 2 Have a discussion with your head of the institution about the process of starting the documentation. Step 3 The head of the institution will discuss with the Central ARC head for the approval and process clearance. Step 4 The Central ARC head will direct to the institution ARC head for its systematic execution and will assist for further clarification. Step 5 The central ARC head can intimate the Director for the changes in documents and process. Step 6 Step 7 This process and the documents can be internally audited by the Central ARC head time to time for the assurance. The IQAC audit will look into the entire process and documents in the schedule audits. Let's learn the documentation