1[SCHEDULE U
(See rules 74, 74A, 74-B, 78 and 78A)
I. Particulars
to be shown in Manufacturing Records
A. SUBSTANCES, OTHER THAN PARENTERAL PREPARATIONS IN
GENERAL.
1.
Serial number
2.
Name of the product
3.
Reference of Master Formula Records.
4.
Lot/Batch Size.
5.
Lot/Batch Number.
6. Date of
commencement of manufacture and date of completion of manufacture and assigned
date of expiry.
7. Name of all
ingredients, specifications quantities required for the lot/Batch size and
quantities actually used. All weighings and measurements shall be carried out
by a responsible person and initialled by him and shall be counter-checked and
signed by the competent technical staff under whose personal supervision the
ingredients are used for manufacture.
8. Control Numbers of raw materials used
in the formulation.
9. Date, time and duration of mixing.
10. Details of environmental
controls like room temperature, relative humidity.
11.Date of granulation, wherever
applicable.
12. Theoretical weight and actual weight of
granules/powder blend.
13. Records of in-processes controls (Periodically
whenever necessary):
(a)
Uniformity of mixing.
(b) Moisture content of granules/powder in case
of Tablet/Capsules.
(c) pH of solution in case of liquid.
(d)
Weight variation.
(e) Disintegration time.
(f) Hardness
(g) Friability test
(h) Leak test in case of strip packing.
(i) Filled volume of liquids.
(j) Quantity of tablets/capsules in the final
container.
(k) Content of ointment in the filled
containers.
14. Date of compression in case of Tablets/date of
filling in case of capsules.
15. Date of
sealing/coating /polishing in case of capsules/tablets wherever applicable.
16. Reference
to analytical Report number stating the result of test and analysis.
17.
Separate records of the
disposal of the rejected batches and of batches withdrawn from the market.
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18. |
The theoretical yield and
actual productions yield and packing particulars indicating the size and
quantity of finished packings. ___________________________________________________________________________ 1. Subs. by . G.S.R.
735(E) , dt. 24.6.1988. |
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19. |
Specimen of label/strip,
carton with batch coding information like Batch Number, date of manufacture,
date of expiry, retail price as applicable stamped thereon and inserts used
in the finished packings. |
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20. |
Signature with date of
competent technical staff responsible for the manufacture. |
|
21. |
Counter-signature of the
head of the testing units or other approved person-in-charge of testing for
having verified the batch records and for having released and batch for sale
and distribution, the quantity released and date of release. |
|
22. |
Date of release of
finished packings and quantity released for sale and distribution. |
|
23. |
Quantity transferred to
warehouse. |
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24. |
For Hypodermic tablets
and ophthalmic preparations, which are required to be manufactured under
aseptic conditions, records shall be maintained indicating the precautions
taken during the process of manufacture to ensure that aseptic conditions are
maintained. |
7. Names of all ingredients, specifications and quantity required for
the Lot/Batch size and quantity actually used. All weighings and measurements
shall be carried out by a responsible person and initialled by him and shall be
countersigned by the technical staff under whose personal supervision the stock
are issued and by another competent technical staff under whose supervision the
ingredients are used for manufacture.
8. Control
numbers of raw materials used in the formulation.
9. Date, time
and duration of mixing.
10. Details of
environmental controls like temperature, humidity, microbial count in the
sterile working areas.
11. pH of the
solution, wherever applicable.
12.
Date and method of
filtration.
13. Sterility test, reference on bulk batch wherever
applicable.
14. Record of check on volume filled.
15. Date of filling.
16. Records of tests employed: -
(a) To ensure that sealed ampoules are leak proof
(b) To check the presence of foreign particles.
(c) Pyrogen test, wherever applicable.
(d) Toxicity test, wherever applicable.
17. Records of checking of instruments and apparatus
of sterilization (indicators).
18.
Records of cleaning and
sterilization of containers and closures, if necessary.
19. Records of sterilization in case of parenteral
preparations which are heat sterilized including particulars of time,
temperature and pressure employed. Such records should be marked to relate to
the batch sterilized.
20. Number and
size of containers filled and quantity rejected.
21. The theoretical yield and actual yield and the
percentage yield thereof.
22. Reference to Analytical report numbers stating whether of standard
quality or otherwise.
23. Specimen of labels, cartons,
etc. with Batch coding information like batch number, date of manufacture, date
of expiry, as applicable, stamped thereon, and inserts used in the
finished packings.
24.
Signature with date of
the component technical staff responsible for manufacture.
25. Particulars regarding the precautions taken during the
manufacture to ensure that aseptic conditions
are maintained.
26. Countersignature of head of the testing unit or person in charge
of testing for having verified the documents and for having released the
product for sale and distribution, the quantity released and date of release.
27. Records for having
transferred to warehouse giving packings and quantities.
28. Separate records of the disposal of the
rejected batches and of all batches withdrawn
from the market.
29.
Records of reprocessing if any and particulars of reprocessing.
II. Records of Raw Materials
Records
in respect of each raw material shall be maintained indicating the date of receipt,
invoice number, name and address of the manufacturer/supplier, batch number,
quantity received, pack size, date of manufacture, date of expiry, if any, date
of analysis and release/rejection by quality control, analytical report number
with special remarks, if any, quantity issued, date of issue and the
particulars of the name and batch numbers of products for the manufacture of
which issued and the proper disposal of the stocks.
III. Particulars to be recorded in the Analytical
Records
A. TABLETS AND CAPSULES.
1.
Analytical report
number.
2.
Name of the sample.
3.
Date of receipt of
sample.
4.
Batch/Lot number.
5.
Protocols of tests
applied.
(a) Description.
(b) Identification.
(c) Uniformity of weight.
(d) Uniformity of
diameter (if applicable).
(e) Disintegration test
(time in minutes).
(f) Any other tests.
(g) Results of Assay.
Note:
Records regarding various tests
applied (including readings and calculations) should be maintained and
necessary reference to these records should be entered in Col. 5 above whenever
necessary.
6.
Signature of the
Analyst.
7. Opinion and signature of the approved Analyst.
B. PARENTERAL PREPARATIONS.
1.
Analytical report number.
2.
Name of the sample.
3.
Batch number.
4.
Date of receipt of samples.
5.
Number of containers filled.
6.
Number of containers received.
7. Protocols of tests applied.
(a) Clarity.
(b) pH wherever applicable.
(c) Identification.
(d) Volume in container.
(e) Sterility – (i) Bulk sample wherever applicable (ii)
container sample.
(f) Pyrogen test, wherever applicable.
(g) Toxicity test, wherever applicable.
(h) Any other tests.
(i) Results of Assay.
Note: Records regarding various tests applied
(including readings and calculations) should be maintained and necessary
reference to these records should be entered in Col. 7 above, wherever
necessary.
8.
Signature of the
Analyst.
9.
Opinion and signature of
the approved Analyst.
PYROGEN TEST:
1. Test Report Number.
2. Name of the sample.
3. Batch Number.
4. Number of rabbits used.
5. Weight of each rabbit.
6. Normal temperature of each rabbit.
7. Mean initial temperature of each rabbit.
8. Dose and volume of solution injected into
each rabbit and time of injection.
9.
Temperature of each rabbit noted at suitable intervals.
10. Maximum temperature.
11. Response.
12. Summed response.
13. Signature of the Analyst.
14.Opinion
and signature of the approved Analyst.
TOXICITY TEST
1. Test Report Number.
2. Name of the sample.
3. Batch Number.
4. Number of mice used and weight of each mouse.
5. Strength and volume of the drugs injected.
6. Date of injection.
7. Results and remarks.
8. Signature of Analyst.
9. Opinion and signature of the approved Analyst.
C.
FOR OTHER DRUGS
1. Analytical report number.
2. Name of the sample.
3. Batch/Lot number.
4. Date of receipt of sample.
5. Protocol of tests applied.
(a) Description.
(b) Identification.
(c) Any other tests.
(d) Results of Assay.
Note:Particulars regarding various tests applied (including
readings and calculations) shall be maintained and necessary reference to these
records shall be entered in Column 5 above, wherever necessary.
6. Signature of Analyst.
7. Opinion and signature of the approved Analyst.
D.
RAW MATERIALS
1. Serial number.
2. Name of the materials.
3. Name of the manufacturer/supplier.
4. Quantity received.
5. Invoice/Challan number and date.
6. Protocols of tests applied.
Note: Particulars regarding various tests applied (including
readings and calculations) shall be maintained and necessary reference to these
records shall be entered in Column 6 above, wherever necessary.
E. CONTAINER,
PACKING MATERIALS ETC.
1. Serial number.
2. Name of the item.
3. Name of the manufacturer/supplier.
4. Quantity received.
5. Invoice/Challan number and date
6. Results of tests applied.
Note: Particulars
regarding various tests applied shall be maintained and necessary reference to
these records shall be entered in Column 6 above, wherever necessary
7. Remarks.
8. signature of the examiner.
Notes: (1) The foregoing provisions represent the
minimum requirements to be complied with by the licensee. The Licensing
Authority may, however, direct the nature of records to be maintained by the
licensee for such products as are not covered by the categories described
above.
2.
The Licensing Authority
may permit the licensee to maintain records in such manner as are considered
satisfactory, provided the basic requirements laid down above are complied
with.
3. The Licensing Authority may at its
discretion direct the licensee to maintain records for such additional
particulars as it may consider necessary in the circumstances of a particular
case.]