Documentation for Manufacture of Pharma Sterile Products
Documentation for Manufacture of Pharma Sterile Products
The Documents relating to the manufacture of sterile products shall be as follows but not limited to these documents only: –
(1) Serial number of the Batch Manufacturing Record.
(2) Name of the product.
(3) Reference to Master Formula Record.
(4) Batch / Lot number.
(5) Batch / Lot size.
(6) Date of commencement of manufacture and date of completion of manufacture.
(7) Date of manufacture and assigned date of expiry.
(8) Date of each step in manufacturing.
(9) Names of all ingredients with the grade given by the quality control department.
(10) Quantity of all ingredients.
(11) Control reference numbers for all ingredients.
(12) Time and duration of blending, mixing, etc. whenever applicable.
(13) pH of solution whenever applicable.
(14) Filter integrity testing records.
(15) Temperature and humidity record whenever applicable.
(16) Records of plate counts whenever applicable.
(17) Results of pyrogen and/or bacterial endotoxin & toxicity.
(18) Records of weight or volume of drug-filled in containers.
(19) Bulk sterility in case of aseptically filled products.
(20) Leak test records.
(21) Inspection records.
(22) Sterilization records including autoclave leakage test records, load details, date, duration, temperature, pressure, etc.
(23) Container washing records.
(24) Total number of containers filled.
(25) Total numbers of containers rejected at each stage.
(26) Theoretical yield, permissible yield, actual yield, and variation thereof.
(27) Clarification for variation in yield beyond permissible yield.
(28) Reference numbers of relevant analytical reports.
(29) Details of reprocessing, if any.
