SEMINAR ON SCHEDULE U
presented by
Y . Shirisha
256212886033
M.Pharmacy 1st year
Department of Pharmaceutics
*
Schedule U of drugs and cosmetics rules,1945 details the particulars to
be shown in the manufacturing records, records of raw materials
&analytical records of drugs.
Particulars to be shown in manufacturing
records .
A. Substances other than parenteral preparations in general.
* Serial number.
* Name of the product.
* Reference of master formula records.
* lot/batch size.
* lot /batch number.
* Date of commencement of manufacture &date of completion of
manufacture &the assigned date of expiry.
* Name of all ingredients , specifications quantities required for the
lot /batch size and quantities actually used.
* All weighings & measurements shall be carried out by a responsible
personal & initialled by him &shall be counter-checked &signed by
the competent technical staff under whose personal supervision the
ingredients are used for manufacture.
* Control numbers of raw materials used in the formulation.
* Date , time and duration of mixing.
* Details of environmental controls like room temperature, relative
humidity.
* Date of granulation, wherever applicable.
* Theoretical weight and actual weight of granules or powder
blend.
* Records of in-processes controls.
* Date of compression in case of tablets or date of filling in case of
capsules.
* Date of sealing ,coating ,polishing in case of capsules or tablets
wherever applicable.
* Reference to analytical report number stating the results of test
and analysis.
* Separate records of the disposal of the rejected batches and of
batches withdrawn from the market.
* The theoretical yield and actual productions yield and packing
particulars indicating the size and quantity of finished packings.
* Specimen of label or 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
* Signature with the date of component technical staff
responsible for the manufacture
* counter-signature of the head of the testing units for other
approved person in charge of testing for having verified the
batch records and for having released the batch for sail and
distribution , the quantity released and date of release.
B . Parenteral preparations
* Serial number.
* Name of the product.
* Reference of master formula records.
* lot/batch size.
* lot /batch number.
* Date of commencement of manufacture and date of
completion of manufacture and the assigned date of expiry.
* 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 personal and initialled by him &shall be counter-
checked &signed by the competent technical staff under
whose personal supervision the ingredients are used for
manufacture.
* Control numbers of raw materials used in the formulation.
* Date , time and duration of mixing.
* Details of environmental controls like room temperature, relative
humidity, microbial count in the sterile working areas.
* pH of the solution, wherever applicable.
* Date and method of filtration.
* Sterility test, reference on bulk batch wherever applicable.
* Record of check on volume filled
* Date of filling
* Records of tests employed
* Records of checking of instrumentations and apparatus of
sterilization
* Records of cleaning and sterilization of containers and
closures , if necessary
* Records of sterilization incase of parenteral preparations
which are heat sterile including particulars of time ,
temperature and pressure employed. Such records should be
marked to relate the batch sterilized.
* Number and size of containers filled and quantity rejected.
* The theoretical yield and actual yield and the percentage
yield.
* Reference to analytical report numbers stating whether of
standard quality .
* Specimen of label or 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
* Signature with the date of component technical staff responsible
for the manufacture
* counter-signature of the head of the testing units for other
approved person in charge of testing for having verified the batch
records and for having released the batch for sail and distribution ,
the quantity released and date of release.
* Records of raw materials
* Records in respect of each raw materials shall be maintained
indicating the quantity received , control reference number ,
quantity issued from time to time, the names and batch numbers of
the products for the manufacture of which the said quantity of raw
materials has been issued and the particulars relating to the proper
disposal of the stocks
Particulars to be recorded in the analytical records
A . tablets and capsules
* Analytical report number.
* Name of the sample
* Date of receipt of sample.
* Batch or lot number
* Protocols of tests applied.
* Signature of analyst
* Opinion and signature of the approved
B . Parenteral preparations
* Protocols of tests applied
* Clarity , pH, volume in container, sterility, pyrogen test, toxicity
test , results of assay.
* Pyrogen test
* Test report number
* Name of the sample
* Batch initial temperature of each rabbit
* Number of rabbits used
* Weight of each rabbit
* Normal temperature of each rabbit
* Signature of the approved analyst
* Dose and volume of solution injected into each rabbit and time of
injection
* Temperature of each rabbit noted at suitable intervals
* Maximum temperature
* Response
* Summed response
* Signature of the analyst
* Opinion and signature of the approved analyst
* Test report number
* Name of the sample
* Batch number
* Number of mice used and weight of each mouse
* Strength and volume of drugs injected
* Date of injection
* Results and remarks
* Signature of analyst
* Opinion and signature of approved analyst
*
C . For other drugs
* Analytical report number.
* Name of the sample
* Date of receipt of sample.
* Batch or lot number
* Protocols of tests applied.
* Signature of analyst
* Opinion and signature of the approved
* Container , packing materials
* Serial number
* name of the item
* Name of the manufacturer or supplier
* Quantity received
* Invoice or challan number and date
* Results of test applied
* Remarks
* Signature of the examiner
It details the particulars that are to be shown in the
manufacturing records and records of raw materials for
cosmetics.
*Schedule U1
Particulars to be shown in manufacturing records
* Serial number.
* Name of the product.
* Reference of master formula records.
* lot/batch size.
* lot /batch number.
* Date of commencement of manufacture and date of completion of
manufacture and the assigned date of expiry.
* Name of all ingredients , specifications quantities required for the
lot /batch size and quantities actually used.
* Control reference numbers in respect of raw materials used in the
formulation
* Reference to analytical report numbers
* Actual production and packing particulars indicating the size and
quantity of finished packings
* Date of release of finished packing for distribution or sale
* Signature of the expert staff responsible for the manufacture
* Records of raw materials
* Records in respect of each raw materials shall be maintained
indicating the quantity received , control reference number ,
quantity issued from time to time, the names and batch numbers of
the products for the manufacture of which the said quantity of raw
materials has been issued and the particulars relating to the proper
disposal of the stocks
* Forensic pharmacy by N.K.Jain.
* www.google.com
*References
Therapeutic Use:
Increased bradykinin is possibly involved in the
therapeutic efficiency & cough produced by ACEIs
Aprotinin (Trasylolol), a kallekrein inhibitor,
used in treatment of acute pancreatitis, carcinoid
syndrome & hyperfibrinolysis
* Kinins
