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.

*SCHEDULE U

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*Separate records of the disposal of the rejected batches and of batches withdrawn from the market.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

*Toxicity test

*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

*Schedule U1

It details the particulars that are to be shown in the manufacturing records and records of raw materials for cosmetics.

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

*References

*Forensic pharmacy by N.K.Jain.

*www.google.com

*Kinins

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