Record Keeping 1 Types of pharmaceutical documentation records

Record Keeping 1

Types of pharmaceutical documentation records 1. Pertaining to formulation industry a) Records of regular activities. b) Records of self audit/ reviews at regular time interval. 2. Pertaining to bulk drug manufacturing 2

Records of regular activities 1. Raw materials 2. Manufacturing processes 3. Packaging 4. Quality Control 5. Distribution 6. Complaints and Product recall 7. Miscellaneous. 3

1. Raw materials a) Purchasing planning- selection of vendor record b) Records of receipts, examination of container and issue of raw materials c) Sampling records 4

e) Raw material analysis records f) Issue and receipt register 5

2. Manufacturing processes a) Master manufacturing records b) Batch manufacturing records 6

3. Packaging records a) Master packaging instructions records b) Batch packaging instructions records c) Inventory records 7

4. Quality Control Records a) Sampling procedures b) In-process control for bulk finished products c) Specifications for bulk/ finished product d) Analysis record 8

e) Specifications for packaging components f) Packaging component analysis records g) Finished product release records h) Special records of finished products 9

i) Records of stability study j) Validation of test method records k) Records of auditing 10

5. Distribution Records a) Finished product receipt and issue register b) Records of drugs to all levels distribution (wholesaler, stockiest retailers, hospitals, doctors) 11

6. Complaints and Product recall a) The complaint records of drugs b) Records of the product recall after complaints of users 12

Miscellaneous Records a) Personal qualifications, training and health records b) Equipments maintenance records c) Sanitation, Waste disposal records 13

THANK YOU 14