Documentation & Record Keeping in Quality Control of Ayurvedic Formulations

Module 7 : Classical and Advanced quality control techniques for Ayurveda Formulations For Ayurvedic Post Graduate dtudents of Rasa Shastra evam Bhaishajya Kalpana - Experential Learning

1. Documentation & Record Keeping in Quality Control of Ayurvedic Formulations By Dr . Hariaumshree NAIR ASSISTANT PROFESSOR PG Dept. of rasashastra evam bhaishajya kalpana sjsach

2. 1. Importance • Ensures traceability, accountability, and reproducibility • Legal proof of compliance with GMP and Drugs & Cosmetics Rules, 1945 • Supports regulatory audits, product recall, and pharmacovigilance

3. 2. Types of Documentation • Master Formula Record (MFR) – Standard recipe • Batch Manufacturing Record (BMR) – Step-by-step batch record • Batch Packaging Record (BPR) – Packaging & labeling details • SOPs – Documented methods • Equipment Log Books – Calibration & maintenance • Raw Material Register – Source, authentication, test reports • In-Process Control Records – Monitored parameters • Finished Product Analysis Report – QC test results

4. 3. Key Records in Quality Control Laboratory • Sample register for raw materials and finished products • Analytical test reports for each batch • Reference standards register • Stability study records • Instrument calibration and maintenance logs • Reagent and chemical inventory register

5. 4. Retention Samples & Record Maintenance • Retain control samples for each batch • Keep records for minimum 5 years (as per AYUSH) • Retain records of recalls, complaints, and investigations

6. 5. Documentation in GMP (Schedule T) • Manufacturing license and premises details • List of technical and QC staff • Batch records, distribution, and market complaints • Standard specifications of raw materials and products

7. 6. Data Integrity Principles (ALCOA+) • Attributable – Who performed the task • Legible – Clear and readable • Contemporaneous – Recorded in real-time • Original – Not altered • Accurate – True to results • + : Complete, Consistent, Enduring, Available

8. 7. Digital Record Keeping (Modern Approach) • Use of LIMS (Laboratory Information Management System) • Barcoding / QR coding for traceability • E-signatures and audit trails for data authenticity

9. 8. Benefits • Ensures quality assurance and consistency • Facilitates inspection readiness • Enhances consumer confidence and global acceptability