Documentation Requirements for Sterile dosage form Injectable preparations
Name of the product.
Reference of master formula record
Batch / lot size
Batch nos. / lot nos.
Date of commencement of mfg. date of completion.
Name of all ingredients, specification and Qty. required for lot / batch size and qty. actually used. All weightings and measurements shall be carried out by responsible person initialed by him and shall be counter signed by technical staff under whose personal supervision stocks are issued by another competent technical staff under who’s supervision ingredients are used for mfg.
Control no’s of raw materials used information.
Date, time and duration of mixing.
Details of environmental controls like temp,humidity,microbial count in sterile working areas.
PH of solution where ever applicable.
Date and method of filtration.
Sterility test, reference on bulk batch where were applicable.
Record of check on volume filled.
Date of filling.
Record of the test employed.
A] To ensure that sealed ampoules are leake proof.
B] To check presence of foreign particles.
C] Pyrogen test when ever applicable.
D] Toxicity test when ever applicable.
17. Records of check of instruments and apparatus for sterilization. (Indicator)
18. Records of cleaning and sterilization of containers and closures if necessary.
19. Records of sterilization in case of parental preparation which are heat sterilized including particulars of time, temp. Pressures, employed such records should be marked to relate to batch sterilized.
20. Number and size and shape of containers filled qty.rejected.
21. The theoretical yield and actual yield and % yield there of.
22. Reference to analytical report numbers starting whatever of std qty. or otherwise.
23. Specimens of labels, cartons etc. w/c batch coding information like batch no.,
Date of mfg. date of expiry as applicable stamped there up on insert, used in finished products.
24. Signature date of competent, technical staff responsible for mfg.
25. Particulars regarding precautions taken during mfg. to ensure that aseptic condition are maintained.
26. Counter signature of head of testing unit or person incharge of testing for hawing verified the documents and for having released product for sale and distribution qty. released and date of release.
27. Records for having transferred to warehouse giving packing and quantities.
28. Separate records of disposal of reject batches of all batches drawn from market.
29. Records of reprocessing if any and particulars of reprocessing.