Documentation for Manufacture of Sterile products
The manufacturing records relating to manufacture of sterile products shall indicate the following details: –
(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.
(30) Name of all operators carrying out different activities.
(31) Environmental monitoring records.
(32) Specimens of printed packaging material.
(33) Records of destruction of rejected containers and printed packaging
materials.
(34) Signature of the competent technical staff responsible for manufacture and testing.
Notes :-
(1) Products shall be released only after complete filling and testing.
(2) Results of the tests relating to sterility, pyrogens, and Bacterial endotoxins shall be maintained in the analytical records.
(3) Validation details and simulation trial records shall be maintained separately.
(4) Records of environmental monitoring like temperature, humidity, microbiological data, etc. shall be maintained. Records of periodic servicing of HEPA filters, sterilizers, and other periodic maintenance of
facilities and equipment carried out shall also be maintained.
(5) Separate facilities shall be provided for filling-cum-sealing of Small Volume Injectables and Large Volume Parenterals.
(6) It is advisable to provide separate facilities for manufacture of Large Volume Parenterals in glass containers and/or plastic containers.
(7) For manufacture of Large volume parenterals in plastic containers, it is advisable to install automatic (with all operations). Form-Fill-Seal machines having one continuous operation.
