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.
Proper documentation
is a primary requirement of CGMP (Current Good Manufacturing Practices) and it
is indeed imperative
that each member of the staff must be careful about documents under his/her
control. The emphasis must be on zero defect, so that the final document kept
as a record, will be defect free.
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.
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.
