Tag Archives: Pesaro and Urbino

SOP for Acceptable Quality Level sampling for Tablets and capsule

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Acceptable Quality Level sampling for Tablets and capsule 2.0 SCOPE:This procedure shall apply to formulation plant of Pharmaceutical Company  that manufacture, package, test, and store or distribute drug products. 3.0 RESPONSIBILITY: All concerned personnel shall responsible to follow the procedure mention …

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STABILITY STUDY MANAGEMENT

STABILITY STUDY MANAGEMENT Stability Study Management – To lay down the procedure to conduct stability studies of the drug product (dosage forms)/ Drug substances (API). This Procedure describes the procedure for assigning the stability of drug substances (Active pharma ingredients) and drug products (Packed finished dosage forms). The purpose of …

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In-process control of oral drug product during manufacturing & Packing

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Objective To lay down the procedure for in-process control of oral drug products during manufacturing & Packing. Scope This procedure is applicable for in-process sampling, analysis, and reporting to be carried out during manufacturing and packing of drug products at the formulation Plant. Responsibility Quality Assurance and production personnel shall …

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SAMPLING OF PACKING MATERIALS

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OBJECTIVE To lay down a procedure for sampling of packaging materials. SCOPE To describe the procedure for sampling of Primary packing materials i.e. Aluminium Foil, Blister Aluminium Foil, PVC Film etc. and secondary packing materials i.e. Cartons, labels, Leaflet shipper etc. RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Quality Assurance Manager PROCEDURE …

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PROCEDURE FOR OPERATION OF UNIT DOSAGE SAMPLER

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1.0       OBJECTIVE To lay down the procedure for operation and cleaning of unit dose sampler. 2.0     SCOPE This SOP shall be applicable for IPQA area in Quality Assurance.             3.0       RESPONSIBILITY In process Quality Assurance Executive /Officer 4.0       ACCOUNTABILITY Head Quality Assurance 5.0       PROCEDURE FOR OPERATING 5.1       Check the Status …

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SOP on QUALITY RISK MANAGEMENT (RISK ASSESSMENT)

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1.0 Objective: To provide a procedure for carrying out Risk assessment, evaluation, mitigation and review of risk by employing appropriate tool of Quality Risk Management Process. 2.0 Scope: Applicable to different aspects of pharmaceutical quality like development, manufacturing, testing, distribution, inspection and submission/review processes throughout the life cycle of drug …

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FDA – Warning Letter 

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FDA – Warning Letter September 10, 2019 For FDA Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more FDA warning Letter …

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Pharma FDA Warning Letter for Derma Pharm A/S MARCS-CMS – November 26

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Teligent Pharma, Inc. MARCS-CMS 587592 — November 26, 2019 For FDA Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more …

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Pharma FDA Warning Letter for OHM Pharma, Inc -November 19

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Pharma FDA Warning Letter for OHM Pharma, Inc MARCS-CMS 586428 — November 19, 2019 For FDA Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed …

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Pharma FDA Warning Letter for Alkermes, Inc.

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For FDA Warning Letter Click Here –   Alkermes, Inc. MARCS-CMS 597260 — December 02, 2019 Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA …

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FDA -WARNING LETTER -March 30, 2023

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FDA -WARNING LETTER -March 30, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, ALI Pharmaceutical Manufacturing, LLC, FEI 1920841, at 4410 S. 102nd Street, Omaha, from September 26 to October 3, 2022. This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for …

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