DOCUMENTATION
INTRODUCTION :-
Documentation is
covered by the Drugs Cosmetic Act 1940/Rules 1945 and is explained in schedule
U of the said act.
Any anomoly in
the documentation, if not explained properly by the staff, is deemed to be
violation and the company is liable for penal action. Hence documentation must
be taken as an individual responsibility and must be given the importance, it
deserves.
Documentation is
relevant in every phase of production facility, be it stores department to
receive and dispense the material or Production department to produce the
formulation or Quality Control department to carry out raw material/in
process/finished product testing or Quality Assurance department to release the
final goods to the customer.
PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS FOR SUBSTANCES OTHER THAN PARENTERAL PREPARATION 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 the 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 initialed
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. Detail 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.
(I) 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
18. The theoretical yield and actual productions
yield and packing particulars indicating the size and quantity of finished
packings.
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.
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 the 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.
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 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.
PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS
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).
(I) Any other tests.
(g) Results of
Assay.
Note : Records regarding
various tests applied (including readings and calculations) should be
maintained and reference to these records should be entered in Col. 5 above
whenever necessary.
6. Signature of the Analyst.
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 test 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 the Analyst.
RAW MATERIAL
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.
CONTAINER, PACKING MATERIAL
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 test 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.
GENERAL ANOMOLIES
Some of the
general anomolies observed in the BMR/BPR by Q.A., have been included in the
following list
a) Overwriting
and excessive cancellations of entries.
b) Signature
of Production officer, competent person missing from the document.
c) Entries
missed on the document, although duly signed by Production officer.
d) Wrong
entries of container numbers.
e) Wrong
subtraction of Gross and Tare weights.
f) Date
column not filled.
g) Sifter number not
ticked.
h) Cleanliness
record not completely filled, although document is duly signed by the production
officer.
i) Remark column not filled. If there is no relevant remark, the
relevant column can have 'Nil' or ' -' as an entry.
j) Some of the operations not bearing the initials of the operators
involved in the operation; although signature of Production officer is
available e.g. mixing operation in Norflox tablets.
k) A series of humidity observations having only one signature at the
top. All the observations must be individually signed.
l) Bulk density, Friability and Sieve analysis figures are available;
but the raw data is not available.
m) Average weight of the tablet after coating is calculated, but the
methodology of calculation was not shown on the BMR.
n) The word
'Production officer', was missing after conclusion of certain important steps
like inspection and hence the relevant page was not signed by the
"Production officer".
o) Temperature
not recorded during drying operation of one of the lots.
p) BMR No./A.R.No. not mentioned.
q) Soaking time does not match.
r) Compressed
air "Dew point" not recorded.
s) ‘Checked
by' not signed.
t) Batch
summary sheet not filled.
u) The
timings in the case of rinsing of pressure vessel in Aerosol manufacturing is
recorded less than the timing required as per SOP.
v) Reconciliation of cans does not tally.
w) The total
weight of foil does not tally.
x) Relevant
S.O.P numbers were not ticked.
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