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    Ipqc 112070804017 Ipqc 112070804017 Presentation Transcript

    • A SEMINAR ON IN PROCESS QUALITY CONTROL(IPQC) ON VARIOUS DOSAGE FORMS GUIDE BY : PRESENT BY: MR.Ashok mahajan Anuj patel M.PHARM. SEM-1(2011) DEPARTMENT OF QUALITY ASSURANCE A.P.M.C. PHARMACY COLLEGE
    • CONTENTS • Definition • Objectives • USFDA cGMP Guidelines • IPQC for Parenteral products • IPQC for Solid dosage forms • IPQC for Semisolid dosage forms • Completion stage • Records and Reports • References
    • Definition In process quality control (IPQC) is a planned system to identify the materials, equipments, processes, and operators; to enforce the flow of manufacturing and packaging operations according to the established rules and practices; to minimize human error or to detect the error if and when it does occur; and to pinpoint the responsibility to the personnel involved in each unit operation of the entire process. In general, in process control procedures are usually rapid and simple tests or inspection that are performed when the manufacturing of the product batch is in process.
    • Objectives: • The primary objective of an IPQC system is to monitor all the features of a product that may affect its quality and to prevent errors during processing. • The in-process checking during manufacturing plays an important role in the auditing of the quality of the product at various stages of production • They are used to detect variations from the tolerance limits of the product so that prompt and corrective actions can be taken.
    • USFDA cGMP guidelines • To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in- process controls, and tests, or examinations to be conducted on appropriate samples of in- process materials of each batch. • Such control procedure shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
    • Continue… • Valid in-process specification for such characteristics shall be consistent with drug product final specifications. • Examination and testing of samples shall assure that the drug product and in-process material conforms to specification. • In-process materials shall be tested for identity, strength, quality, and purity as appropriate, and approved or rejected by the quality control unit, during the production process, e.g., at commencement or completion of significant phases or after storage for long periods.
    • IPQC for Parenteral products • Checking the bulk solution, before filling, for drug contents, pH, color, clarity and completeness of solution • Checking the filled volume of liquid or the filled weight of sterile powders for injection in the final containers at predetermined intervals during filling • Testing for leakage of flame-sealed ampoules • Subjecting the products to physical examination (visually or mechanically) for appearance, clarity and particulate contamination
    • Continue… • Examining the sterility indicator placed in various areas of the sterilizer for each sterilization operation • Submitting the product for sterility testing or other predetermined biologic test to establish the safety and other parameters of the product.
    • IPQC for solid dosage forms(Tablets and Capsules) • Determining the drug content of the formulation • Checking the weight variation for tablets and capsules at predetermined intervals during manufacturing • Checking the disintegration and/or dissolution time, hardness and friability of the tablets, at least during the beginning, middle and end of the production or at prescribed intervals during manufacturing
    • Continue… • Testing soluble tablets for compliance with solution time requirements • Examining products by line inspection or other equally suitable means and removing the defective units prior to packaging
    • IPQC for semisolid dosage forms • Checking for uniformity and homogeneity of drug content prior to the filling operation. • Determining the particle size of the preparation when appropriate. • Checking the appearance, viscosity, specific gravity, sediment volume and other physical parameters at prescribed intervals. • Testing for filling weight during the filling operation • Testing for leakage on the finished jars or tubes.
    • Completion stage • Actual yield are checked against theoretical value and the representative samples are withdrawn for laboratory testing by the control inspector according to the predetermined sampling plan. • The operator actively performing the process, their supervisors, and the control inspector must all verify that the entire operation was accomplished in the prescribed manner. • Occasionally, materials in bulk storage are sampled at random and are examined to determine that no detectable change has taken place, and that the batch is satisfactory for final packaging.
    • Records and Reports • The batch production records and other needed documents are then delivered to the quality control office together with the withdrawn samples of the products. • These records and test results are reviewed for conformance to specification and cGMP. The bulk finished products are held in quarantine until they are released for packaging by quality control personnel.
    • References • Leon Lachman, H.A.Lieberman, J.L.Kanig, “The Theory and Practice of Industrial Pharmacy”;Varghese Publishing House; 804 • Sidney H. Willig; “Good Manufacturing Practices for Pharmaceuticals” Fifth edition; Marcel Dekker Inc.;109