Daito Kasei Kogyo Co Ltd USFDA warning Letter 1/18/18
Daito Kasei Kogyo Co Ltd USFDA warning Letter 1/18/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
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Polaroisin International Co., Ltd. USFDA warning Letter 1/25/18
Polaroisin International Co., Ltd. USFDA warning Letter 1/25/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Celltrion Inc. USFDA warning Letter 1/26/18
Celltrion Inc. USFDA warning Letter 1/26/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Cosmecca Korea Co., Ltd. USFDA warning Letter 2/2/18
Cosmecca Korea Co., Ltd. USFDA warning Letter 2/2/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Imprimis Pharmaceuticals USFDA warning Letter 12/21/17
Imprimis Pharmaceuticals USFDA warning Letter 12/21/17 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Continental Manufacturing Chemist, Inc. USFDA warning Letter 12/21/17
Continental Manufacturing Chemist, Inc. USFDA warning Letter 12/21/17 For Warning Letter Click here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Investra-24hs USFDA warning Letter 12/28/17
Investra-24hs USFDA warning Letter WARNING LETTER The United States (U.S.) Food and Drug Administration (FDA) recently reviewed your websites (listed at the bottom of this letter) and determined that they offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites listed below offer unapproved new drugs…
Casmara Cosmetics, S.A. USFDA warning Letter 2/12/18
Casmara Cosmetics, S.A. USFDA warning Letter 2/21/18 For Warning Letter Click the Link – Casmara Cosmetics, S.A. 2/12/18 For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Questions and answers: GMP compliance for active substances (Annex 1: Manufacture of sterile medicinal products)
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: GMP compliance for active substances (EU GMP guide part II)
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 as per EU GMP(European Medicines Agency)
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 (Part – I)
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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Human interventions in aseptic processing
Human interventions in aseptic processing It is appropriate to focus on human interventions performed during aseptic processing because no other factor has the same potential for introducing contamination. Sterilization processes, environmental sanitization, room design, and heating and ventilation systems are all substantially less significant as sources of contamination. Personnel continuously shed microorganisms and particles to their surroundings and gowning materials cannot…
Validation of computerized systems as per WHO Technical Report Series, No. 937
Validation of computerized systems 1. General 2. System specification 3. Functional specification 4. Security 5. Back-ups 6. Validation 7. Validation of hardware and software 7.1 Hardware 7.2 Software General Computer systems should be validated at the level appropriate for their use and application. This is of importance in production as well as in quality control. The use…
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Analytical method validation as per WHO Technical Report Series, No. 937
Analytical method validation as per WHO Technical Report Series, No. 937 Principle General Pharmacopoeial methods Non-pharmacopoeial methods Method validation Characteristics of analytical procedures Principle This appendix presents some information on the characteristics that should be considered during validation of analytical methods. Approaches other than those specified in this appendix may be followed and may be acceptable. Manufacturers should…
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Cleaning validation protocols and reports as per WHO Technical Report Series, No. 937
Cleaning validation protocols Cleaning validation should be described in cleaning validation protocols,which should be formally approved, e.g. by the quality control or quality assurance unit. In preparing the cleaning validation protocol, the following should be considered: — disassembly of system — precleaning — cleaning agent, concentration, solution volume, water quality — time and temperature — fl ow…
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ANDAs: Stability Testing of Drug Substances and Products – Questions and Answers
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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Qualification as per WHO Technical Report Series, No. 937
Qualification as per WHO Technical Report Series, No. 937 Qualification should be completed before process validation is performed. The process of qualification should be a logical, systematic process and should start from the design phase of the premises, equipment, utilities and equipment. Depending on the function and operation of the equipment, utility or system, only installation qualification (IQ)…
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Validation as per WHO Technical Report Series, No. 937
Validation as per WHO Technical Report Series, No. 937 Approaches to validation Two basic approaches to validation — First is based on evidence obtained through testing (prospective and concurrent validation), and Second is based on the analysis of accumulated (historical) data (retrospective validation). Whenever possible, prospective validation is preferred. Retrospective validation is no longer Used Nowadays. Both prospective…
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Investigating Out-of-Specification (OOS) in Pharmaceutical Production
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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