Tuesday , May 26 2020

Recent Posts

DGFT guidelines for Barcoding as per GS1 Standards Pharmaceuticals

 

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

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 formulation Plant of Torque Pharmaceutical (P) Ltd., Unit-I, Dappar. Responsibility …

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SAMPLING OF PACKING MATERIALS

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

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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Batch Release Statement for Pharmaceutical Product

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Performace Qualification Protocol of Dispensing Booth

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Procedure for Microbiological Monitoring of Purified water

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Inprocess Control of Packing Lines

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Sampling of Intermediates and Finished Products

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Inprocess Control During Tablets Manufacturing

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SOP to prevent the spread of COVID 19 infection at workplace

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SOP on Line Clearance

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QUALITY RISK MANAGEMENT (RISK ASSESSMENT)

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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Risk Assessment Sample Format on Tablets Manufacturing Process

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USFDA Warning Letter for Lohxa LLC

Lohxa LLC MARCS-CMS 581785 — September 10, 2019 For 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 USFDA warning Letter …

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USFDA Warning Letter for Derma Pharm A/S MARCS-CMS

Teligent Pharma, Inc. MARCS-CMS 587592 — November 26, 2019 For 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 USFDA warning …

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USFDA Warning Letter for OHM Pharma, Inc

OHM Pharma, Inc. MARCS-CMS 586428 — November 19, 2019 For 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 USFDA warning …

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USFDA Warning Letter for Alkermes, Inc.

Alkermes, Inc. MARCS-CMS 597260 — December 02, 2019 For 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 USFDA warning Letter …

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USFDA Warning Letter for Pharmalab Enterprises, Inc.

Pharmalab Enterprises, Inc. MARCS-CMS 588432 — December 10, 2019 For 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 USFDA warning …

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USFDA Warning Letter for Wild Child WA Pty Ltd.

Wild Child WA Pty Ltd. MARCS-CMS 589463 — December 06, 2019 For 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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