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    Guidelines To Handle Potent Drugs PDF

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    Vi Vek

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    © All Rights Reserved
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    of 18
    Se Dr. Reddy's Laboratories Ltd. Document No: DRL/PS/001 NoofPages —: 1 of 18 Effective Date: 11.12.2008 RevisionNo —_: 00 Title: POLICY TO HANDLE POTENT DRUG SUBSTANCE/ DRUG PRODUCT FOR DEVELOPMENT & MANUFACTURING IN DR. REDDY’S POLICY APPROVA\ PROPOSED BY: NAME Dr. Shashank Lulay DESIGNATION Sr. Ditector, Development Quality Assurance SIGNATURE WITHDATE | \_. ony Sz\- ult> [rooe APPROVED BY: NAME Dr. Darshan B Makhey DESIGNATION Vice President - Global Quality signature win pate | fat ao nber 1, 2008 Sd/- GV Prasad, Vice-Chairman and Chief Executive Officer Sd/- Satish Reddy, Managing Director and Chief Operating Officer ‘Sd/- Saumen Chakraborty, President - Corporate & Global Generics Operations Sd/- Prabir Jha, Senior Vice President & Global Chief of HR Dr. Reddy's Laboratories Ltd. Document No: DRL/PS/001 NoofPages : 2 of 18 Effective Date: 11.12.2008 RevisionNo —_: 00 Title: POLICY TO HANDLE POTENT DRUG SUBSTANCE/ DRUG PRODUCT FOR DEVELOPMENT & MANUFACTURING IN DR. REDDY’S: 1.0 Objective ‘The objective of this policy is to define criteria for development & manufacturing of Drug Substance and Drug products of various categories of potent molecules (viz, Cytotoxics. Steroids, Antingoplastics, Immunomodulators. Hormones and peptide). This policy emphasizes on control of cross contamination through containment and segregation along with Patient and Operator safety. 20 Scope This policy is applicable for all National and Intemational locations of Dr. Reddy's Laboratories Lita 3.0 Date of commencement This policy will come into effect from 11.12.2008, 4.0 Background It is essential to establish an approach for appropriate categorization for handling of the potent compounds. The categorization and defining the criteria for handling the potent compounds is required where there is no regulatory guidance available. -Exclusions This policy does not attempt to guide the extent of cleaning requirement for any molecule. Such criteria shall be guided by research and or bibliographical information, specific to a particular molecule. ‘This policy does not include the drugs for which guidance is provided by Regulatory agencies and Health authorities. 6.0 Definitions POTENT DRUG MOLECULES: Active Pharmaceutical compounds or ingredients, which at a very low dose/concentration can produce profound Pharmacological adverse effects or Toxicological effects. Depending upon the category, potent compounds are known as Carcinogens, Mutagens, Cytotoxics, sensitizers etc. CONTAINMENT: Engineering controls for manufacturing, pilot plant, and lab operations to minimize the emission of substances into the work environment .The intent are the control of air surface and Personnel contamination. OCCUPATIONAL EXPOSURE LIMIT (OEL}: Refers to airborne concentration of substances that will not result in adverse effects to healthy working personnel, when exposed for 08 hrs/day, maximum 40 hrs! week. Compounds with OEL at or below 10 ug / m?ot air in & hrs time weighed average for the operators are considered to be highly potent. These compounds may produce incapacitating effect and need immediate medical intervention. OEL is to be established for the safely of the operators/ personnel involved in the handling, SS eee Dr. Reddy’s Laboratories Ltd. Document No — : DRL/PS/001 NoofPages : Sof 18 Effective Date: 11.12.2008 Revision No 00 Title: POLICY TO HANDLE POTENT DRUG SUBSTANCE/ DRUG PRODUCT FOR DEVELOPMENT & MANUFACTURING IN DR. REDDY'S DEDICATED: Can be defined as facilities and or equipments when intended to be used ‘exclusively for development or manufacturing of specitic category/group of drug substances or drug products. How potent compounds enter the ‘Ocular Environment Heath _‘inhalatfon Ingestion & Safety issues 10 May through Iypical OL: mochanical Ingestion through based on 4 transfer fom mouth and nese this route the hands “Transdermally very effective when Absorption mixed with certain Mechanical exposure soivents teanster to through the Mechanical transfer membranes on i skin’ dlothing, Inhalation equipment and feet can Intravenously from transfor accidental puncture mater tothe ‘Cross contamination children Intrayonously as a result of sharp ‘object penetration contaminated with the product 6.0 Route of Conta jon of Potent Compounds ‘The potent compounds may enter the body of Operator through different routes viz. Ingestion through mouth and inhalation through nose, Transdermally, Mechanically through clothes, punclure/injury at any part of the body accidentally during handling 7.0 Requirements 7.1 Whenever a new molecule or compound is selected for Development and or ‘manufacturing, following information shall be collected for categorization: Therapeutic category -Potency/Dose of the molecule (active compound)-mgiday -Material safety data (for Toxicological/Safety data) -OEL -Scale of operation ~ Patient safety information or Package Insert Sn Dr. Reddy’s Laboratories Ltd. Document No Effective Date : DRLIPS/001 2 11.12,2008 No of Pages Revision No 40f18 :00 Title: POLICY TO HANDLE POTENT DRUG SUBSTANCE/ DRUG PRODUCT FOR DEVELOPMENT & MANUFACTURING IN DR. REDDY'S 7.2 Technical information and data described in this policy provides the information and correlation among OEL, PB-ECL Classes and severity of the exposures. The required Containment and GMP is recommended based on this information. The appropriate safety level for the operators can be decided for the new molecules based on the exposure control ranges. 7.3 Depending upon the potency, and potentiat adverse pharmacological effect, complexities/criticality of the manufacturing operation at Lab scale, or at commercial scale can be evaluated with reference to the PB-ECL classification (performance based exposure contro! limits) and exposure severties. (Tab-1, Reference: AIHA JOURNAL (AMERICAN INDUSTRIAL HYGENE ASSOCIATION), 57:3342(1998) PB-ECL Classification DRL Maximum Toxicity & Potent Categorization | Classification ciass| Dally | OELRANGE (Based on OEL) ((n-house ) Dosage (ug!) (mg/day) 1 > 100 | 1000-10,000 | Category A : Low Toxicity OEL : More than 0.5 mg/m? Category A 2 > 10-100 | 100-1000 i.e, More than 600 g/m? Category B : Intermediate Toxicity 3 0.1-10 10-100 OEL : 0.5 mg/m*to 10 g/m? Category B Le. 10 pg/ m®to 500 yag/ m® Category C : Potent 4

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