Study OF Drug Schedules – P,T & U - Jurisprudence - 2020

Drug Schedules P, T, and U as per pharmaceutical jurisprudence. It covers the classification, legal regulations, and significance of these schedules. Schedule P focuses on the standards for the storage of drugs, Schedule T pertains to requirements for good manufacturing practices (GMP) in Ayurveda, and Schedule U deals with documentation requirements for drug manufacturing and quality control. Understanding these schedules is crucial for compliance, ensuring drug safety, and maintaining regulatory standards in pharmaceutical practice.
Bachelor Of Pharmacy, Semester V, Pharmaceutical Jursiprudence.

1. Study OF Drugs Schedule – P,T & U Submitted To – Mrs. Neha Yadav Ma’am Submitted By - Pushpak Singh B.Pharm (Sem. – V) NIET (Pharmacy institute), Greater Noida

2. It deals With – Life period of drug Conditions of the storage of drugs Period in months between date of manufacture and date of expiry which the labelled potency period of the drug should not exceed under the conditions of storage Specified. Name of Drug Period in months Storage Condition Ampicillin 36 Cool place Adriamycin 30 Cool place Riboflavin 60 Well closed container, cool place

3. Name of Drug Dosage Forms Pack Sizes Famotidine Tablets 14 tabs Glyceryl Trinitrate Capsules 25 cap  Atenolol Tablet 14 tabs

4. Requirements of factory premises and hygienic conditions for Ayurvedic,siddha and Unani drugs. For getting a certificate of ‘Good Manufacturing Practices' of Ayurveda, Siddha-Unani drugs The applicant shall made application on plain paper providing the information on existing infrastructure of the manufacturing unit the licensing authority shall after verification of the requirements as per Schedule ‘T’ issue the certificate within a period of 3 months in form 26-E. Part 1 :- Good Manufacturing Practices for premises and materials Part 2 :- Requirements of Plant and equipment’s.

5. Gives the particulars to be shown in manufacturing records. Gives the particulars to be recorded of raw materials. Gives the particulars to be recorded in analytical records. The records or registers shall be retained for a period of 5 years for Drugs & 3 years for Cosmetics from the date of manufacture .

6. Substances parenteral preparations & other than parenteral preparations in general Name of the product. Reference of master formula records. batch size. 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 weighing's & 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. Common Conditions -

7. Tablets and capsules - Particulars to be recorded in the analytical records 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 Approved Parenteral preparations Records of raw materials Protocols of tests applied Clarity , pH, volume in container, sterility, pyrogen test, toxicity test , results of assay.

8. Manufacturing, raw materials and analytical records of cosmetics. The licensee shall keep records of the details of each batch of cosmetic manufactured by him and of raw materials used therein as per particulars specified in Schedule U(1). Such records shall be retained for a period of three years.

9. Particulars to be shown in manufacturing records – 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.

10. Thank You !