Tag: india

Investra-24hs USFDA warning Letter 12/28/17

Posted on By Pharmaceutical Guidanace

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…

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USFDA WARNING LETTER

Questions and answers: GMP compliance for active substances (EU GMP guide part II)

Posted on By Pharmaceutical Guidanace

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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Audit and Guideline

Questions and answers on Data integrity as per EU GMP(European Medicines Agency)

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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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Audit and Guideline

Deviation Handling and Quality Risk Management (Part – I)

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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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Quality Assurance

Non-sterile process validation as per WHO Technical Report Series, No. 937

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Non-sterile process validation as per WHO Technical Report Series, No. 937 1. Principle 2. Scope 3. General 4. Prospective validation 5. Concurrent validation 6. Retrospective validation 7. Revalidation 8. Change control Principle Process validation provides documented evidence that a process is capable of reliably and repeatedly rendering a product of the required quality. The principles of…

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Audit and Guideline

Validation of computerized systems as per WHO Technical Report Series, No. 937

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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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Audit and Guideline