LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR INSPECTION LINE Dosage Form: Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time INSPECTION [Released / Not Released / Hold / Rejected / Not…
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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COMPRESSION Dosage Form: Tablet Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas /Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time COMPRESSION [Released / Not Released / Hold / Rejected / Not Applicable]…
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Education in Ukraine offers Courses & Fees Sumy State University (SSU), Sumy Courses & Fees B.Tech. (Bachelor of Technology) Available Courses Course Name Duration Fees(Annual) BA in Mechanical engineering 4.0 Years 1.21 Lacs BA in Heat and power engineering 4.0 Years 1.21 Lacs BA in Engineering Materials Science 4.0 Years 1.21 Lacs BA in…
Zhejiang Ludao Technology Co., Ltd.(USFDA warning Letter) 2/23/18 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 Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Nan San (HK) Pharmaceutical Factory Ltd.(USFDA warning Letter) 2/23/18 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 Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
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Nowcos Co., USFDA warning Letter 2/14/18 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 Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Questions and answers EU GMP guide annexes: Supplementary requirements 1. How should the integrity of sterilising filters be verified? H+V June 2007 Annex 1, paragraph 85 states, ‘the integrity of the sterilised filter should be verified before use and should be confirmed immediately after use by an appropriate method such as a bubble-point, diffusive-flow or…
Questions and answers Basic requirements for active substances used as starting materials: GMP compliance for active substances 1. How can GMP compliance for active-substance manufacturers be demonstrated? H+V April 2011 Directive 2001/83/EC as amended (Directive 2001/82/EC for veterinary medicinal products) states that manufacturing-authorisation holders are obliged to use, as starting materials, only active substances that have been manufactured in accordance with the detailed guidelines on…
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Questions and answers on Data integrity Data integrity Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities.It is a fundamental requirement of the pharmaceutical quality system described in EU GMP chapter 1, applying equally to manual (paper) and electronic systems. Promotion of a quality culture together with implementation of organisational and technical measures…
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Deviation Handling and Quality Risk Management Purpose The aim is to contribute to the understanding of a quality risk management approach in the handling of deviations from a practical perspective as per WHO expectations. The intent is to support the effective and timely implementation of tools related to deviation management encountered during vaccine and biological…
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Stability Testing of Drug Substances and Products A. General QUESTIONS 1: What is the scope of and implementation date for the FDA stability guidance? ANSWERS 1: The FDA stability guidance covers all new ANDAs under the Federal Food, Drug, and Cosmetic Act, section 505 (j), and DMFs (Type II for drug substances that support the ANDAs). It…
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Investigating Out-of-Specification This topic provides how to evaluate out-of specification (OOS) test results. the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside…
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COMPRESSION MACHINE URS (USER REQUIREMENT SPECIFICATION) Table of Contents of compression machine URS General Salient Features Operational Requirements Utilities Maintenance Inspection and Testing Commissioning and Documentation Training Packaging Deviations Delivery TECHNICAL REQUIREMENT OF COMPRESSION MACHINE URS Equipment No. : To be embossed/imprinted conspicuously on the equipment Description: 37-station double rotary compression machine, D tooling PLC controlled compaction…
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